NCCTG
N o rt h c e n t r a l C a n c e r T r e at m e n t g r o u p
Working with Mayo Clinic to bring the latest cancer research to the community
Status Report 2007
For Group Meeting
September 24-27, 2007
Privileged Communication: Not for publication or reference
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Gastrointestinal Program
The NCCTG GI Committee continues to work on providing a providing a broader menu of trials
for patients with GI cancers. The recent reporting of several European and North American trials
have continued to reshape our trials. In response to the current rapidly changing field of GI
oncology the NCCTG GI Committee is developing both innovative phase II and potentially
practice defining phase III trials as described below.
The NCCTG GI Committee and those of the other Cooperative Groups continue to work more
closely in developing and promoting joint trials, as well as setting national agendas. This activity
is occuring through the GI Steering Committee. As noted previously, over the next several years
there will likely be a more limited number of phase III trials in order to accrue to those trials
more rapidly. A variety of trials are currently in development and should open in the next
several months. The breadth of trials and new opportunities continues to grow, maintaining
NCCTG’s prominence as a leader in inovative therapies for GI cancer patients.
Colorectal/Anal Cancer Program:
Adjuvant Studies:
Colon Cancer: ECOG 5202, a, trial for Stage II patients, opened in August 2005 and has been
endorsed by NCCTG. The trial requires central review of tissue for markers of high risk for
recurrence. It will therefore be important to coordinate trial participation with the patient’s
surgeon in order to allow adequate time for tissue submission and review (estimated to take up to
2 weeks). Patients with high risk markers will be randomized to FOLFOX6 with or without
bevacizumab. The NCCTG Stage III adjuvant trial (N0147) continues to accrue patients.
Patients receive 5-FU/LV administered as an infusion together with oxaliplatin (modified
FOLFOX6). Patients are randomized to receive 24 weeks of therapy given in one of two arms:
mFOLFOX6 with or without cetuximab. Tissue and blood will be requested from all patients.
This trial is one of the highest priority for the NCCTG GI committee and for the GI Intergroup.
Rectal Cancer: Two rectal neo/adjuvant trials are currently open. The NSABP developed trial
(R-04) randomizes patients to preoperative radiation combined with either capecitabine or an
infusion of 5-FU or these two arms with the addition of oxaliplatin (total of 4 arms). A second
trial led by ECOG (E5204) is evaluating FOLFOX with or without bevacizumab following the
completion of neoadjuvant radiation and surgery. The intent will be to have patients go onto R-
04 and then after surgery go onto E5204. NCCTG has endorsed both R-04 and E5204
recognizing the need for a national effort to complete these two trials.
Colorectal Liver Metastases: In the setting of resectable colorectal cancer metastases limited to
the liver, building on the NCCTG led phase II trial (N9945) of intraarterial FUDR, oxaliplatin,
and capecitabine, a randomized phase III trial of capecitabine and oxaliplatin +/- intraarterial
FUDR opened last year. This trial is being led by NSABP (C-09) with participation by NCCTG.
The NSABP trial design differs from N9945 by eliminating the fifth week of the treatment cycle,
a week of rest with no treatment. N014A was opened in late 2004 as a follow-up to 96-42-51.
N014A is ongoing, assessing the efficacy of FOLFOX + cetuximab in patients with not
optimally resectable liver-only metastases.
Advanced Disease:
First-line: . The current phase III trial for first-line therapy of mestastic colorectal cancer is
jointly led by CALGB and SWOG (80405). All of the Cooperative Groups have agreed to
support a single phase III trial. This trial randomizes patients to cetuximab, bevacizumab, or
both agents with chemotherapy. The physician, in consultation with the patient, will be allowed
to chose either FOLFOX or FOLFIRI.
While this trial is accruing patients, a randomized phase II NCCTG trial is currently in
development (N0548). This trial will assess the potential benefit of dual antibody therapy with
cetuximab and bevacizumab, but without concomitant chemotherapy. At the time of progression
patients will be randomized to receive either FOLFOX and both antibodies or FOLFOX and
bevacizumab. This trial is unique and innovative in the use of a non-chemotherapy regimen as
first-line therapy. It provides the potential for delaying the need for chemotherapy as well as the
toxicity associated with chemotherapy.
Second-line: SWOG and the NCCTG have jointly developed a phase III second-line trial
(S0600) with the active support of NCIC. This trial will evaluate the activity of FOLFIRI and
cetuximab, with or without bevacizumab, in patients who have disease progression while on
either FOLFOX or XELOX and bevacizumab. This trial will be very important to the GI
Intergroup effort and to helping to define the appropriate use of bevacizumab in second-line
therapy. This trial is now open for accrual.
NCCTG will also conduct a phase II trial of sorafenib and bevacizumab (N054C) in the second-
line setting. This unique combination has shown potentially promising activity in other settings
and offers the potential to have a chemotherapy-free interval while maintaning disease control
with a potentially less toxic combination. This trial and N0548 build on our program assessing
the benefits of non-chemotherapy containing regimens in patients with metastatic disease.
Translational and Record Studies: A variety of studies assessing outcomes from patients
entered on N9741 are currently underway or in development. This includes pharmacogenetic
analyses, assessment of patients achieving a CR, and occurrence of neurotoxicity. Additional
work is underway related to a published report in the NEJM from NCCTG and Dr. Steven
Gallinger’s lab at the University of Toronto showing that patients whose tumors show high levels
of microsatellite instability are actually adversely affected when given 5-FU based adjuvant
chemotherapy.
Anal Cancer: The RTOG led trial of 5-FU + either mitomycin or cisplatin with radiation in anal
cancer closed recently after completing accrual. Potential replacement trials are being discussed
through an Intergroup taskforce and within the NCCTG GI Committee.
Upper Gastrointestinal Cancer Program:
Gastroesophageal Cancer:
Adjuvant/Neoadjuvant: An adjuvant trial from CALGB of ECF or 5-FU before and after 5-
FU/RT (80101) remains open for resected stomach cancer and is available through the CTSU. A
new phase II trial (N044E) opened last year, assessing the activity of carboplatin, pemetrexed,
and radiation The trial accrued 6 patients and then closed for a planned interim toxicity analysis.
That analysis is now complete and the trial should be open for accrual by the time of the Spring
meeting.
Metastatic: A trial of paclitaxel, carboplatin, and PS-341 for metastatic esophageal cancer
opened in August of 2005. Based on the interim analysis it was decided that the results did not
warrant continuing accrual to the trial. In addition, a maintenance therapy trial of ZD1839 for
locally advanced esophageal cancer was also closed do to poor accrual.
A new trial is in-development for patients with metastatic gastroesophageal adenocarcinoma and
will assess the potential benefit of sunitinib added to chemotherapy.
Pancreatic Cancer:
Adjuvant: The GI Intergroup has opened an adjuvant phase II trial.
Locally Advanced: A phase II trial (N0349) previously closed after meeting its planned accrual.
This trial assessed the combination of infusional 5-FU, oxaliplatin, and radiation, building on a
successful regimen used in esophageal cancer. Analysis of the results of this trial did not show
meaningful improvement compared to what would be expected from 5-FU and radiation alone.
A new trial is now in-development that will evaluate the potential benefit of adding an EGFR
inhibitor to 5-FU and radiation. Building on preclinical work and clinical findings from trials in
other cancer types, N064A will evaluate the combination of panitumumab, 5-FU, and radiation
in patients with locally advanced pancreatic cancer. In addition this trial will assess the potential
benefit of maintainance therapy with panitumumab after completing radiation.
Metastatic: The phase II trial of of gemcitabine, oxaliplatin, and bevacizumab (N034A) recently
closed after it accrued very quickly. Given the failure of oxaliplatin in ECOG E6201 and
bevacizumab in CALGB 80303 to improve outcomes over gemcitabine alone, there remains
uncertainty about where to focus current clinical research efforts. The NCCTG GI Committee
is currently focusing on dual EGFR inhibition. N064B will evaluate the combination of
gemcitabine, erlotinib, and panitumumab. A randomized phase II trial design will be used that
will include a contempary comparison arm of gemcitabine and erlotinib.
Hepatobiliary cancer:
A phase II trial (N044J) for hepatocellular carcinoma recently closed. This trial was assessing
the investigational agent AZD2171 that acts on several angiogenesis targets. The trial of
gemcitabine and pemetrexed (N9943) for gallbladder and biliary tract cancer also recently
closed. Early results from this trial did not show efficacy that would have warranted a phase III
trial. New opportunities are being pursued in both of these areas.
Small Bowel Cancer:
A new trial for carcinoma of the small bowel is now open. N0543 will assess the activity of a
combination of capecitabine, oxaliplatin, and irinotecan utilizing UGT 1A1 testing to
appropriately dose irinotecan.
Summary of GI Program Goals
Goals for the near future include identifying active regimens for phase II testing based on
preclinical leads identified in collaboration with the Novel Therapeutics Committee and
maintaining a strong record of accrual. There will also be a focus of developing several new
phase III trials. The integration of translational studies whenever appropriate into trials also
remains a priority.
Program Status Reports for GASTROINTESTINAL - September 2007
Lower GI
N0147 A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorou-
racil(5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after
CurativeResection for Patients with Stage III Colon Cancer
N014A A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU),Leuco-
vorin (CF), and Cetuximab (C225) for Patients With UnresectableHe-
patic Metastases from Metastatic Adenocarcinoma of the Colon
orRectum
N0341 Phase II Trial of Irinotecan + 5-Fluorouracil + Leucovorin +Oxaliplatin
as First-Line Treatment for Metastatic Colorectal CancerPatients
N0346 A Phase II Trial of Celecoxib (Celebrex) and Capecitabine
(Xeloda)Combined with Pelvic Irradiation as Neoadjuvant Treatment of
Stage IIor III Adenocarcinoma of the Rectum
N0347 Young-Onset Colorectal Cancer: Clinical Characteristics and Intervals-
for Recurrence and Survival
N0543 A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan,Oxali-
platin, and Capecitabine as First-Line Therapy for Advanced Small-
Bowel Adenocarcinoma
Upper GI
N0041 Phase II Trial of Gemcitabine and Docetaxel in Patients WithMeasurable
Unresectable or Metastatic Hepatocellular Carcinoma
N0342 A Phase II Study of Maintenance ZD1839 (Iressa) in Patients withLo-
cally Advanced Esophageal Cancer after Treatment Given with Cura-
tiveIntent
N0349 Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External-
Beam Radiation Followed by Gemcitabine in Patients with LocallyAd-
vanced Pancreatic Cancer
N034A Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in
PatientsWith Metastatic Pancreatic Adenocarcinoma
GI NCCTG GI Committee Table of Contents - Page 1 of 4
Program Status Reports for GASTROINTESTINAL - September 2007
N044B A Phase II Trial of PS-341 in Combination with Paclitaxel andCarbopl-
atin for Metastatic Adenocarcinoma of the Lower Esophagus,Gastroe-
sophageal Junction, and Gastric Cardia
N044E A Phase II Trial of Preoperative Radiation and Chemotherapy(Pemetr-
exed and Carboplatin) for Locally Advanced Esophageal Cancer
N044J A Phase II Study of AZD2171 in Patients with Locally Advanced
orMetastatic Hepatocellular Carcinoma
N9943 Phase I/II Trial of Gemcitabine and ALIMTA in Patients with Measur-
ableor Evaluable, Unresectable or Metastatic Biliary Tract Carci-
noma(Intrahepatic, Extrahepatic, Ampulla of Vater) and
GallbladderCarcinoma
Other Closed Trials
924652 Phase II Trial: Evaluation of the Role of Multiple MetastasectomyCom-
bined with Systemic and Hepatic Artery Infusion Chemotherapy forCol-
orectal Carcinoma Metastatic to the Liver
964152 A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma
ofthe Stomach or Gastroesophageal Junction Incorporating Pretreat-
mentand Posttreatment Biopsies for Evaluation of Tumor Thymidylate-
Synthase, MIB-1, Topoisomerase I, and p53
MC9944 Colorectal Cancer Screening: Fecal Blood vs. DNA
N0044 A Phase II Trial of Preoperative Radiation and Chemotherapy(Pacli-
taxel, Carboplatin, and Continuous Infusion 5-FU) for LocallyAdvanced
Esophageal Cancer
N0144 Profile of Long-Term Survivors on NCCTG Advanced Colorectal Can-
cerTreatment Trials
N0242 A Phase II Study of Docetaxel and Capecitabine in Patients withMeasur-
able Metastatic Adenocarcinoma of the Stomach andGastroesophageal
Junction
N0442 Determination of Clinical Significance of Caspase Inhibitory Pro-
teins,Regulators of Death Receptor (DR) -Mediated Apoptotic Pathway,
andCorrelation of Apoptotic Proteins with Previously Studied Biomark-
ersin Stage II and III Colorectal Carcinoma
GI NCCTG GI Committee Table of Contents - Page 2 of 4
Program Status Reports for GASTROINTESTINAL - September 2007
N9841 A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Ver-
susOxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in
PatientsWith Advanced Colorectal Carcinoma Previously Treated With
5-FU
N9942 A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy inPa-
tients with Locally Advanced Pancreatic Cancer
N9945 A Phase II Trial Evaluating Multiple Metastasectomy Combined With-
Hepatic Artery Infusion of Floxuridine (FUDR) and Dexamethasone
(DXM)Alternating With Systemic Oxaliplatin (OXAL) and Capecitab-
ine (CAPCIT)for Colorectal Carcinoma Metastatic to the Liver
Protocol Concepts
N0548 Randomized Phase II Trial of Cetuximab/Bevacizumab (CB) as Pallia-
tiveFirst-Line Therapy in Patients with Advanced Colorectal CancerFol-
lowed by FOLFOX+CB vs. FOLFOX+B
N054C Phase II Study of Sorafenib/Bevacizumab as Second-Line Therapy inPa-
tients with Metastatic Colorectal Cancer
N064A Phase II Study of Panitumumab, Chemotherapy and External BeamRa-
diation in Patients with Locally Advanced Pancreatic Cancer
N064B Phase II Randomized Trial of Panitumumab, Erlotinib, and Gemcitab-
inevs. Erlotinib and Gemcitabine in Patients with Untreated, Metastatic-
Pancreatic Adenocarcinoma
N0743 Validation of GHI (Genomic Health) Algorithm for Estimation of theR-
isk of Recurrence at 5 Years in Patients with Stage III Colon CancerRan-
domized to Receive 5FU/LV on NCCTG Protocols 894651 and 914653
CTSU
80101 Phase III Intergroup Trial of Adjuvant Chemoradiation After Resec-
tionof Gastric or Gastroesophageal Adenocarcinoma
R-04 A Clinical Trial Comparing Preoperative Radiation Therapy and-
Capecitabine with or without Oxaliplatin with Preoperative Radiation-
Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with
orwithout Oxaliplatin in the Treatment of Patients with OperableCarci-
noma of the Rectum
GI NCCTG GI Committee Table of Contents - Page 3 of 4
Program Status Reports for GASTROINTESTINAL - September 2007
GI NCCTG GI Committee Table of Contents - Page 4 of 4
NCCTG Status Report for Study N0147 - September 2007
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-
FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resec-
tion for Patients with Stage III Colon Cancer
Purpose of - Primary Objective
Study: 1) To compare the disease-free survival in patients with stage III (TxN1-2M0)
colon cancer randomized to 24 weeks of adjuvant chemotherapy with either:
(1) Oxaliplatin (OXAL) + 5-fluorouracil/leucovorin (5-FU/LV) (FOLFOX
6m) or (2) FOLFOX 6m + C225.
- Secondary Objectives
1) To compare the overall survival in two groups of patients with stage III (Tx,
N1-2, M0) colon cancer randomized to 24 weeks of adjuvant chemotherapy
receiving FOLFOX with or without C225.
2) To compare disease-free and overall survival among EGFR expressing
patients randomized to FOLFOX with or without C225.
3) To assess toxicities resulting from the addition of C225 to chemotherapy.
4) To compare the quality of life, measures of patient satisfaction, nutrition,
and cancer risk in patients treated with FOLFOX with or without C225,
using four patient-completed questionnaires.
5) To evaluate gene environment and epigenetic environment interactions in
colorectal cancer patients.
6) To evaluate the impact of nutritional agents on cellular pathways in colorec-
tal carcinogenesis.
Study Chairs: Steven R. Alberts M.D. QC Specialist: Lisa M. Finstuen
Suresh G. Nair M.D.
Statistician: Daniel J. Sargent Ph.D. Nurse Resource:
Status: 02/10/2004 Activated Projected Number of Patients: 2648
Excluded: 35 Final Accrual: NA
Stratification Histology Lymph node involvement
Factors:
Schema: Randomize (Enrolled after 6/1/05)
Arm A: OXAL + 5FU + CF (ie, FOLFOX 6m)
Arm D: OXAL + 5FU + CF + C225 (ie, FOLFOX 6m + C225)
Treating Schedule:
Arm Agent Dose Route Days Freq
A Oxaliplatin (FOL- 85 mg/m2 IV infusion 500 ml D5W 1 Q14 days
FOX) over 120 minutes
GI NCCTG GI Committee N0147 - Page 1 of 14
NCCTG Status Report for Study N0147 - September 2007
Arm Agent Dose Route Days Freq
D Oxaliplatin (FOL- 85 mg/m2 IV infusion 500 ml D5W 1 Q14 days
FOX + C225) over 120 minutes
* Leucovorin 400 mg/m2 In 250 ml D5W IV infus- 1 Q14 days
tion over 120 minutes
* 5-fluorouracil 400 mg/m2 IV push 1 Q14 days
* 5-fluorouracil 2400 mg/m2 IV, via an ambulatory 1, after leucovorin Q14 days
infusion pump or choice
over 46-48 hrs
# Cetuximab 400 mg/m2 IV over 2 hours given 1 (Cycle 1 only) Week 1
before chemotherapy
# Cetuximab 250 mg/m2 IV over 1 hour (undiluted 8 (Cycle 1 only) Week 2
2 mg/ml)
# Cetuximab 250 mg/m2 IV over 1 hour (undiluted 1 and 8 (Subse- Weekly
2 mg/ml) given before quent Cycles)
chemotherapy
* For Arms A and D
# For Arm D
Study Design: As of the summer of 2005, this study was reduced to a two-arm trial evaluating
the primary endpoint of disease-free survival. The two arms that will be compared are FOLFOX
alone versus FOLFOX + C225 (i.e., Arms A & D). Historically, the best data available on the
outcome of patients with resected stage III colon cancer comes from Intergroup Study 0089,
where the 3-year, disease-free survival in stage III patients was 64%. For the purposes of plan-
ning this study, we assumed that FOLFOX will provide at least some incremental benefit over
this 64% 3-year disease-free survival. Therefore, as the basis for the sample size calculations for
the current trial, we assumed a 3-year disease-free survival of 68% in the arm with the poorest
outcome. We note that this rate is intermediate between the 64% observed in INT 0089, and the
72% rate recently observed for FOLFOX in the MOSAIC trial in stage III patients. We addition-
ally assumed an accrual period of 3 years, a minimum follow-up on all patients of 2 years, and a
model for disease-free survival (with annual failure rates based on data from INT 0089 and
NCCTG 914653). A sample size of 1150 patients per arm will result in 615 total events, provid-
ing 90% power to detect a hazard ratio of 1.3 for this comparison, at 0.05 level of significance.
Accrual: This study opened to accrual on February 10, 2004. On June 1, 2005, enrollment was
limited to arms A and D, based on results reported by other trials. A total of 1491 patients have
been registered at this time, with 1112 concurrently enrolled to arms A and D.
Patient Characteristics: See Patient Characteristics Table for more information.
GI NCCTG GI Committee N0147 - Page 2 of 14
NCCTG Status Report for Study N0147 - September 2007
Available Information: Currently, there are 16 ineligible patients, 14 patients that have refused
their initial treatment assignment (ie, cancelled), and 5 patients declared to have a major protocol
violation.
Adverse Events: Adverse Event data is currently available on 1199 patients (all arms). Com-
mon grade 4 events (percent of patients) include ischemia/cerebral (0.5), neutropenia (12.2),
thrombosis (1.4), hypersensitivity (0.5), and ischemia/infarction (0.3). Thirteen patients have
died during treatment (diarrhea-Arm C, acute colitis-Arm B, ischemia/infarction-Arm A, ven-
tric asystol-Arm A, 2 hemorrhage/CNS-Arm D, 2 sudden deaths with unknown reasons-Arm D,
encephalopathy-Arm D, multi-organ failure-Arm D, thrombosis-Arm D, small intestine
obstruction-Arm D, and colon infection-Arm D). See the Adverse Events table for more infor-
mation.
Study Status: This study is currently open to accrual for sites whose IRBs have approved
Addendum 5 - registering patients and collecting data via the Clinical Trials Support Unit (i.e.,
CTSU).
Accrual Table:
Randomizing Total Past 6 Past 12
Group Entered Months Months
NCCTG 431 136 224
CTSU 1060 318 548
Total Group Accrual 1491 454 772
Baseline Characteristics Table:
Arm Arm Arm Arm Arm Arm
Characteristics
A B C D E F
Adherence
Yes 87 18 11 72 8 6
No 534 93 100 485 37 40
Gender
f 296 53 50 270 20 21
m 325 58 61 287 25 25
Histology
High (poorly or undifferentiated) 156 25 28 143 10 12
Low (well or moderately differentiated) 465 86 83 414 35 34
Lymph node involvement
1-3 381 71 70 341 29 29
>4 240 40 41 216 16 17
Race
GI NCCTG GI Committee N0147 - Page 3 of 14
NCCTG Status Report for Study N0147 - September 2007
Arm Arm Arm Arm Arm Arm
Characteristics
A B C D E F
White 550 100 100 489 37 43
Black or African American 39 6 7 36 5 2
Native Hawaiian or Other Pacific Islande 4 0 1 3 0 0
Asian 17 4 2 20 3 0
American Indian or Alaska Native 2 1 1 4 0 0
Not reported: patient refused or not ava 6 0 0 4 0 0
Unknown: Patient unsure 3 0 0 1 0 1
Was There Bowel Obstruction?
Yes 117 15 22 99 5 12
No 504 96 89 458 40 34
Was There Bowel Perforation?
Yes 39 9 4 42 2 2
No 582 102 107 515 43 44
GI NCCTG GI Committee N0147 - Page 4 of 14
NCCTG Status Report for Study N0147 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 485
Arm B Evaluable Patients: 106
Arm C Evaluable Patients: 107
Arm D Evaluable Patients: 420
Arm E Evaluable Patients: 39
Arm F Evaluable Patients: 42
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 0 0 2 0 57 12 0 0
B 0 0 0 0 15 14 0 0
C 0 0 1 1 19 18 0 0
D 0 0 5 1 49 12 0 0
E 0 0 0 0 3 8 0 0
F 0 0 1 2 3 7 0 0
LEUKOPENIA A 0 0 3 1 2 0 0 0
B 0 0 1 1 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 8 2 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
THROMBOCYTOPENIA A 0 0 0 0 3 1 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 2 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
LEUKOPENIA A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Allergy/Immunology HYPERSENSITIVITY A 0 0 6 1 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 2 2 0 0 0 0
D 0 0 16 4 5 1 0 0
E 0 0 1 3 0 0 0 0
F 0 0 1 2 0 0 0 0
Cardiovascular L VENTRICULAR FAIL A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
GI NCCTG GI Committee N0147 - Page 5 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 1 3 0 0
F 0 0 0 0 0 0 0 0
ISCHEMIA/INFARCTION A 0 0 0 0 0 0 1 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 1 1 0 0
D 0 0 2 0 3 1 0 0
E 0 0 2 5 1 3 0 0
F 0 0 0 0 0 0 0 0
THROMBOSIS A 0 0 14 3 6 1 0 0
B 0 0 3 3 2 2 0 0
C 0 0 4 4 1 1 0 0
D 0 0 6 1 6 1 1 0
E 0 0 1 3 1 3 0 0
F 0 0 0 0 1 2 0 0
ARRHYTHMIA-SVT A 0 0 1 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 1 2 0 0
ATRIAL FIBRILLATION A 0 0 0 0 0 0 0 0
B 0 0 0 0 1 1 0 0
C 0 0 0 0 0 0 0 0
D 0 0 1 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 1 2 0 0
VENTRIC ASYSTOL A 0 0 0 0 0 0 1 0
B 0 0 0 0 1 1 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
TROPONIN I INC A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 2 0 0 0
E 0 0 2 5 0 0 0 0
GI NCCTG GI Committee N0147 - Page 6 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
F 0 0 0 0 0 0 0 0
Constitutional Symptoms FATIGUE A 0 0 20 4 1 0 0 0
B 0 0 2 2 1 1 0 0
C 0 0 7 7 0 0 0 0
D 0 0 19 5 2 0 0 0
E 0 0 1 3 0 0 0 0
F 0 0 2 5 0 0 0 0
Dermatology/Skin RASH A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 32 8 0 0 0 0
E 0 0 5 13 0 0 0 0
F 0 0 6 14 1 2 0 0
ACNE NOS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 32 8 1 0 0 0
E 0 0 5 13 0 0 0 0
F 0 0 6 14 0 0 0 0
Gastrointestinal NAUSEA A 0 0 12 2 0 0 0 0
B 0 0 10 9 0 0 0 0
C 0 0 7 7 0 0 0 0
D 0 0 16 4 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 7 17 0 0 0 0
DEHYDRATION A 0 0 7 1 0 0 0 0
B 0 0 2 2 0 0 0 0
C 0 0 5 5 0 0 0 0
D 0 0 17 4 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 1 2 0 0 0 0
VOMITING A 0 0 14 3 1 0 0 0
B 0 0 8 8 0 0 0 0
C 0 0 6 6 0 0 0 0
D 0 0 9 2 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 4 10 0 0 0 0
DIARRHEA-NO COLOSTOM A 0 0 36 7 2 0 0 0
B 0 0 15 14 0 0 0 0
GI NCCTG GI Committee N0147 - Page 7 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 13 12 1 1 1 1
D 0 0 57 14 2 0 0 0
E 0 0 6 15 0 0 0 0
F 0 0 6 14 0 0 0 0
SMALL INTESTN OBSTRU A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 1 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Hemorrhage HEMORRHAGE-CNS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 1 0 2 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Infection/Febrile Neutropenia FEBRILE NEUTROPENIA A 0 0 3 1 1 0 0 0
B 0 0 2 2 0 0 0 0
C 0 0 3 3 0 0 0 0
D 0 0 8 2 5 1 0 0
E 0 0 1 3 0 0 0 0
F 0 0 0 0 1 2 0 0
INFECTION A 0 0 3 1 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
IMPLANT SITE INFECTN A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 1 2 0 0
CATHETER INFECTN A 0 0 1 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
GI NCCTG GI Committee N0147 - Page 8 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
F 0 0 0 0 0 0 0 0
Blood Infectn A 0 0 0 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Blood infectn A 0 0 1 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 1 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 1 2 0 0
Colon infectn A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 1 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Metabolic/Laboratory HYPOCALCEMIA A 0 0 0 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 0 0 0 0
D 0 0 1 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
HYPOKALEMIA A 0 0 10 2 2 0 0 0
B 0 0 2 2 0 0 0 0
C 0 0 1 1 0 0 0 0
D 0 0 18 4 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 1 2 0 0 0 0
HYPOPHOSPHATEMIA A 0 0 1 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 2 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 1 2 0 0 0 0
HYPERGLYCEMIA A 0 0 11 2 1 0 0 0
B 0 0 8 8 0 0 0 0
GI NCCTG GI Committee N0147 - Page 9 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 6 6 0 0 0 0
D 0 0 8 2 0 0 0 0
E 0 0 1 3 0 0 0 0
F 0 0 1 2 0 0 0 0
Musculoskeletal MUSCLE WEAKNESS A 0 0 0 0 1 0 0 0
B 0 0 0 0 1 1 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
MYOSITIS A 0 0 0 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Neurology SYNCOPE A 0 0 1 0 0 0 0 0
B 0 0 1 1 0 0 0 0
C 0 0 1 1 0 0 0 0
D 0 0 2 0 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
ISCHEMIA-CEREBRAL A 0 0 1 0 3 1 0 0
B 0 0 0 0 1 1 0 0
C 0 0 1 1 0 0 0 0
D 0 0 1 0 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 1 2 0 0
DEPRESSION A 0 0 1 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 1 1 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 1 2 0 0 0 0
CONFUSION A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 1 3 0 0
GI NCCTG GI Committee N0147 - Page 10 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
F 0 0 0 0 0 0 0 0
NEURO-SENSORY A 0 0 9 2 2 0 0 0
B 0 0 2 2 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 13 3 0 0 0 0
E 0 0 1 3 0 0 0 0
F 0 0 2 5 0 0 0 0
NEURO A 0 0 53 11 2 0 0 0
B 0 0 1 1 0 0 0 0
C 0 0 5 5 0 0 0 0
D 0 0 26 6 0 0 0 0
E 0 0 3 8 1 3 0 0
F 0 0 0 0 0 0 0 0
ENCEPHALOPATHY A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 1 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Pain MYALGIA A 0 0 1 0 0 0 0 0
B 0 0 0 0 1 1 0 0
C 0 0 0 0 0 0 0 0
D 0 0 1 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
ARTHRALGIA A 0 0 0 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
PAIN-ABDOMINAL A 0 0 6 1 1 0 0 0
B 0 0 1 1 0 0 0 0
C 0 0 1 1 0 0 0 0
D 0 0 8 2 1 0 0 0
E 0 0 1 3 0 0 0 0
F 0 0 2 5 0 0 0 0
ANGINA PECTORIS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
GI NCCTG GI Committee N0147 - Page 11 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 0 0 0 0 0 0
D 0 0 0 0 1 0 0 0
E 0 0 1 3 0 0 0 0
F 0 0 1 2 0 0 0 0
PAIN-HEADACHE A 0 0 1 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 2 2 0 0 0 0
D 0 0 2 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
PAIN-EXTREMITY A 0 0 0 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 1 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Pulmonary EFFUSION-PLEURAL A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
PULMONARY FIBROSIS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 1 2 0 0
PNEUMONITIS A 0 0 4 1 1 0 0 0
B 0 0 0 0 1 1 0 0
C 0 0 0 0 0 0 0 0
D 0 0 3 1 0 0 0 0
E 0 0 1 3 0 0 0 0
F 0 0 1 2 0 0 0 0
HYPOXIA A 0 0 1 0 0 0 0 0
B 0 0 0 0 1 1 0 0
C 0 0 1 1 0 0 0 0
D 0 0 1 0 0 0 0 0
E 0 0 0 0 0 0 0 0
GI NCCTG GI Committee N0147 - Page 12 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
F 0 0 0 0 0 0 0 0
PNEUMOTHORAX A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 1 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
PULMONARY A 0 0 0 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
DYSPNEA A 0 0 6 1 1 0 0 0
B 0 0 3 3 0 0 0 0
C 0 0 1 1 1 1 0 0
D 0 0 6 1 0 0 0 0
E 0 0 3 8 0 0 0 0
F 0 0 2 5 0 0 0 0
Renal /Genitourinary CREATININE A 0 0 0 0 1 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Death MULTI ORGAN FAILURE A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 1 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
SUDDEN DEATH A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 1 1
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 2 0
E 0 0 0 0 0 0 0 0
F 0 0 0 0 0 0 0 0
Vascular VASC ACCESS COMPLIC A 0 0 11 2 0 0 0 0
B 0 0 3 3 0 0 0 0
GI NCCTG GI Committee N0147 - Page 13 of 14
NCCTG Status Report for Study N0147 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 5 5 0 0 0 0
D 0 0 5 1 0 0 0 0
E 0 0 1 3 0 0 0 0
F 0 0 1 2 1 2 0 0
Maximum Grade Adverse Event A 0 0 135 28 85 18 2 0
B 0 0 33 31 21 20 1 1
C 0 0 40 37 22 21 1 1
D 0 0 203 48 72 17 9 2
E 0 0 20 51 6 15 0 0
F 0 0 22 52 10 24 0 0
GI NCCTG GI Committee N0147 - Page 14 of 14
NCCTG Status Report for Study N014A - September 2007
A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), Leucovorin
(CF), and Cetuximab (C225) for Patients With Unresectable Hepatic
Metastases from Metastatic Adenocarcinoma of the Colon or Rectum
Purpose of - Treatment
Study: 1) Primary Endpoint: To evaluate the surgical resectability rate of patients
with not optimally resectable advanced colorectal carcinoma confined to the
liver after treatment with cetuximab, oxaliplatin, 5-fluorouracil, and leucov-
orin.
2) Secondary Endpoint: To assess the response rate, toxicity, quality of life
and overall survival in patients with not optimally resectable advanced col-
orectal carcinoma confined to the liver, after treatment with cetuximab,
oxaliplatin, 5-fluorouracil, and leucovorin.
Study Chairs: Steven R. Alberts M.D. QC Specialist: Carol A. Leonard
Ellison F. Kalda II M.D.
Patrick J. Flynn M.D.
Statistician: Michelle R. Mahoney M.S. Nurse Resource: Gwen Finck R.N., OCN
Status: 12/03/2004 Activated Projected Number of Patients: 73
Excluded: 2 Final Accrual: NA
Stratification None
Schema: Register
C225 + OXAL + 5FU + CF (Phase A)
Surgery (Phase B)
C225 + OXAL + 5FU + CF (Phase C)
Treating Schedule:
Arm Agent Dose Route Days Freq
C225 400 mg/m2 IV over 2 hours 1 Cycle 1 only
C225 250 mg/m2 IV over 1 hr (undiluted 2 8 Cycle 1 only
mg/ml)
C225 250 mg/m2 IV over 1 hour (undiluted 1, 8 Starting Cycle 2 & Subsequent
2 mg/ml) Cycles Q 2 weeks
OXAL 85 mg/m2 In 250 ml D5W IV over 2 1, Q 2 weeks
hours (Start 30 min after
C225)
CF 400 mg/m2 In 250 ml D5W IV over 2 1 Q 2 weeks
hours concurrently with
oxal
5-FU 400 mg/m2 IV bolus after leucovorin 1 Q 2 weeks
GI NCCTG GI Committee N014A - Page 1 of 4
NCCTG Status Report for Study N014A - September 2007
Arm Agent Dose Route Days Freq
5-FU 2400 mg/m2 Continuous 46 hour IV 1-2 Q 2 weeks
infusion after bolus 5-FU
Study Design: This study replaces NCCTG 97-46-51, (Alberts et. al. (JCO 2005)) which
observed surgical resection rate (complete and partical resecations) of 35% (15/42), in the same
population and following treatment with Oxaliplatin, 5-FU, and CF. In the current trial, three
outcomes are possible and in the end the combination therapy will be declared either (1) ineffec-
tive if 16 or fewer complete/partial resections are observed, (2) inconclusive if 17 or 18 com-
plete/partial resections are observed, or (3) promising if at least 19 complete/partial resections
are oberved in all 67 evaluable patients. An interim analysis will be conducted at the time the
25th patient is evaluable. Six complete/partial resections in 25 evaluable patients at this time
will warrant continuing enrollment to a total of 67 patients. Note that patients are prescreened
for EGFR status prior to going on study.
Accrual: This study has had an accrual of 31 patients thus far. Please see Accrual Table for
details.
Patient Characteristics: See Patient Characteristics table for details.
Available Information: One patient is ineligible and one patient had a major treatment viola-
tion.
Adverse Events: Adverse Event data is currently available on 27 patients. 19 patients have
experienced a grade 3+ adverse event. Commonly occuring grade 3 events (percent of patients)
include neutropenia (33%), dehydration(22%), diarrhea-no colostomy(19%), neuro-sensory
(19%), SGPT(ALT)(11%), vomiting(11%), and hyponatremia(11%). Four patients have experi-
enced a grade 4+ adverse event. Grade 4 events include neutropenia(15%) and leukopenia(7%).
One patient died as a result of having blood infection considered probably related to treatment.
See the Adverse Events table for more information.
Study Status: The study is temporarily closed for the interim anlysis.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Allegheny WP 2 0 1
Carle 1 1 1
GI NCCTG GI Committee N014A - Page 2 of 4
NCCTG Status Report for Study N014A - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Des Moines 2 1 1
Duluth 1 0 1
Fargo 2 0 0
Green Bay 1 0 1
Gulf CCOP 5 1 3
Jacksonville 2 1 1
Lehigh 2 0 1
MN CGOP 2 0 0
Mayo 1 0 0
Metro MN 1 1 1
Mo Valley 1 0 0
Peoria 3 1 2
Scottsdale 1 0 0
Sioux Falls 1 0 0
St. Cloud 1 0 1
Upstate Carol 1 0 0
Wichita 1 1 1
Total Membership Accrual 31 7 15
Baseline Characteristics Table:
Arm
Characteristics
A
Gender
f 13
m 18
Race
White 29
Black or African American 2
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 27
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 8 30 9 33 4 15 0 0
LEUKOPENIA A 18 67 1 4 2 7 0 0
ANEMIA A 9 33 1 4 1 4 0 0
THROMBOCYTOPENIA A 15 56 1 4 1 4 0 0
Allergy/Immunology HYPERSENSITIVITY A 1 4 0 0 1 4 0 0
Cardiovascular HYPOTENSION A 2 7 0 0 1 4 0 0
THROMBOSIS A 0 0 1 4 1 4 0 0
ATRIAL FIBRILLATION A 0 0 0 0 1 4 0 0
GI NCCTG GI Committee N014A - Page 3 of 4
NCCTG Status Report for Study N014A - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Constitutional Symptoms FATIGUE A 17 63 1 4 1 4 0 0
WEIGHT LOSS A 7 26 0 0 0 0 0 0
Dermatology/Skin ALOPECIA A 10 37 0 0 0 0 0 0
DRY SKIN A 7 26 0 0 0 0 0 0
SKIN RXN-HAND/FOOT A 4 15 1 4 0 0 0 0
RASH A 22 81 0 0 1 4 0 0
PRURITUS A 3 11 0 0 0 0 0 0
Gastrointestinal ANOREXIA A 9 33 2 7 0 0 0 0
NAUSEA A 11 41 3 11 0 0 0 0
STOMATITIS A 10 37 1 4 0 0 0 0
DEHYDRATION A 0 0 6 22 1 4 0 0
CONSTIPATION A 4 15 0 0 0 0 0 0
TASTE A 3 11 0 0 0 0 0 0
DYSPEPSIA A 4 15 0 0 0 0 0 0
VOMITING A 5 19 3 11 0 0 0 0
DIARRHEA-NO COLOSTOM A 16 59 5 19 0 0 0 0
ANUS MS FS A 3 11 0 0 0 0 0 0
Hepatic SGOT (AST) A 7 26 2 7 1 4 0 0
SGPT (ALT) A 6 22 3 11 0 0 0 0
HYPOALBUMINEMIA A 4 15 2 7 0 0 0 0
BILIRUBIN A 2 7 1 4 0 0 0 0
Infection/Febrile Neutropenia Blood Infectn A 0 0 0 0 0 0 1 4
Metabolic/Laboratory HYPOCALCEMIA A 6 22 0 0 0 0 0 0
HYPONATREMIA A 2 7 3 11 0 0 0 0
HYPERKALEMIA A 3 11 0 0 0 0 0 0
HYPOKALEMIA A 2 7 2 7 0 0 0 0
ACIDOSIS A 0 0 0 0 1 4 0 0
HYPOMAGNESEMIA A 6 22 1 4 0 0 0 0
HYPERGLYCEMIA A 5 19 1 4 0 0 0 0
ALK PHOSPHATASE A 10 37 1 4 0 0 0 0
Neurology INSOMNIA A 3 11 1 4 0 0 0 0
NEURO-SENSORY A 16 59 5 19 0 0 0 0
Pain MYALGIA A 2 7 1 4 0 0 0 0
PAIN-ABDOMINAL A 5 19 0 0 0 0 0 0
Pulmonary COUGH A 8 30 0 0 0 0 0 0
HYPOXIA A 0 0 0 0 1 4 0 0
DYSPNEA A 8 30 1 4 1 4 0 0
Maximum Grade Adverse Event A 8 30 11 41 7 26 1 4
GI NCCTG GI Committee N014A - Page 4 of 4
NCCTG Status Report for Study N0341 - September 2007
Phase II Trial of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin as
First-Line Treatment for Metastatic Colorectal Cancer Patients
Purpose of 1) To evaluate tumor response rate to CPT-11/OXAL/5-FU/CF as first-line
Study: treatment in patients with advanced colorectal carcinoma.
2) To evaluate time to tumor progression, time to treamtent failure, treatment
toxicity, and overall survival.
3) To assess the quality-of-life during chemotherapy in patients with advanced
colorectal carcinoma.
4) To determine whether UGT1A1 polymorphism is related to toxicity (espe-
cially leukopenia, diarrhea, neutropenia) or response in this chemotherapy
program.
Study Chairs: Charles Erlichman M.D. QC Specialist: Carol A. Leonard
Muhammad Salim M.D.
Statistician: Bruce W. Morlan M.S. Nurse Resource: Gwen Finck R.N., OCN
Status: 04/08/2005 Activated Projected Number of Patients: 100
Perm. Closed
Excluded: 1 Final Accrual: 14
Stratification None
Factors:
Schema: Register
A) CPT-11 + OXAL + CF + 5FU
Treating Schedule:
Arm Agent Dose Route Days Freq
A CPT-11 175 mg/m2 IV over 90 minutes in 500 1 Every 3 weeks
ml NS or D5W
A OXAL 85 mg/m2 IV over 2 hours in 250 ml 1 Every 3 weeks
D5W after CPT-11
A CF 20 mg/m2 IV as short infusion prior 2-5 Every 3 weeks
to 5-FU
A 5-FU 240 mg/m2 Over 90 minutes via IV 2-5 Every 3 weeks
infusion pump in 250 ml
NS
GI NCCTG GI Committee N0341 - Page 1 of 3
NCCTG Status Report for Study N0341 - September 2007
Study Design: The primary endpoint of the study is confirmed tumor response. This is a two
stage Fleming design with 50 patients per stage. If 21 or fewer successes are seen in stage 1 we
will stop the study for poor results. If 31 or more successes are seen in stage 1 we will conclude
the treatment may be effective. Otherwise we will proceed to stage 2. At the end of stage 2 we
will conclude the treatment is not suited for further research if there are 47 or fewer successes
and we will conclude the treatment may be effective if there are 48 or more successes.
Accrual: 14 patients have been accrued.
Patient Characteristics: N0341 Baseline Characteristics:
- Median age = 64.0 (range 51-74).
- Gender distribution: 1 female, 13 male.
Adverse Events: There has been one patient with a Grade 5 event (cardiovascular) and there
have been 14 Grade 4 events in 4 patients, all of which are related to treatment. See the adverse
events table for more details.
Study Status: This study closed. History:
- 5 March 2004: opened for accrual
- 17 August 2004: accrual suspended due to toxicity (per the Toxicity Stopping Rules).
- 8 April 2005: study was closed permanently due to toxicity.
- 16 February 2007: No patients are receiving treatment.
Accrual Table:
Randomizing Total
Membership Entered
Bismarck 1
Carle 6
Duluth 5
Rapid City 1
Wichita 1
Total Membership Accrual 14
Baseline Characteristics Table:
GI NCCTG GI Committee N0341 - Page 2 of 3
NCCTG Status Report for Study N0341 - September 2007
Arm
Characteristics
A
Gender
f 1
m 13
Race
White 14
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 12
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 3 25 5 42 1 8 0 0
LEUKOPENIA A 4 33 4 33 1 8 0 0
ANEMIA A 4 33 0 0 0 0 0 0
LYMPHOPENIA A 2 17 1 8 0 0 0 0
THROMBOCYTOPENIA A 5 42 1 8 0 0 0 0
Cardiovascular HYPOTENSION A 0 0 0 0 1 8 0 0
SINUS TACHYCARDIA A 0 0 0 0 1 8 0 0
CARDIOVASCULAR A 0 0 0 0 0 0 1 8
Constitutional Symptoms FATIGUE A 3 25 0 0 1 8 0 0
CONSTITUTIONAL SYMPT A 2 17 0 0 0 0 0 0
Dermatology/Skin ALOPECIA A 10 83 0 0 0 0 0 0
Gastrointestinal NAUSEA A 7 58 1 8 0 0 0 0
DEHYDRATION A 1 8 0 0 1 8 0 0
ILEUS A 0 0 0 0 1 8 0 0
VOMITING A 5 42 1 8 0 0 0 0
DIARRHEA-NO COLOSTOM A 5 42 2 17 1 8 0 0
Infection/Febrile Neutropenia FEBRILE NEUTROPENIA A 0 0 2 17 0 0 0 0
Metabolic/Laboratory HYPOCALCEMIA A 0 0 0 0 1 8 0 0
ACIDOSIS A 0 0 0 0 1 8 0 0
HYPERGLYCEMIA A 1 8 3 25 0 0 0 0
Neurology NEURO-SENSORY A 8 67 0 0 0 0 0 0
NEURO A 5 42 0 0 0 0 0 0
Pain PAIN-ABDOMINAL A 1 8 1 8 0 0 0 0
Maximum Grade Adverse Event A 3 25 6 50 2 17 1 8
GI NCCTG GI Committee N0341 - Page 3 of 3
NCCTG Status Report for Study N0346 - September 2007
A Phase II Trial of Celecoxib (Celebrex) and Capecitabine (Xeloda) Combined
with Pelvic Irradiation as Neoadjuvant Treatment of Stage II or III Adenocar-
cinoma of the Rectum
Purpose of 1) The primary goal is to evaluate the pathological CR rate based upon patho-
Study: logical examination of the resected tumor specimen campared to the base-
line rectal endosonographic tumor stage.
2) Secondary goals include: (1) determining the safety and tolerability, (2) ana-
lyze cellular and molecular markers as predictors of efficacy, (3) prospec-
tively assess rectal function, (4) evaluate time to recurrence/progression.
- Phase II
1) Determine the rate of pathologic complete response after neoadjuvant ther-
apy with celecoxib combined with Xeloda and XRT in T3-4NO-1 rectal
cancer patients.
2) Determine safety and tolerability of celecoxib + Xeloda+ XRT.
Study Chairs: Frank A. Sinicrope M.D. QC Specialist: Carol A. Leonard
James Dewitt Bearden III M.D.
Statistician: Bruce W. Morlan M.S. Nurse Resource: Linda Arneson R.N.
Status: 12/03/2004 Activated Projected Number of Patients: 58
12/09/2005 Perm. Closed
Excluded: None Final Accrual: 3
Stratification None
Factors:
Schema: Register
RT + Celecoxib + Capecitabine
Surgery
Capecitabine
Treating Schedule:
Arm Agent Dose Route Days Freq
A Celecoxib* 200 mg BID (two PO in two does given am 1-7 Q week x approx. 5.5 Weeks
doses daily) & pm (total of 400 mg/
day)
A Capecitabine* 825 mg/m@ BID PO in two does given am 1-5 Q week x approx. 5.5 Weeks
(two does daily) & pm (total of 1650 mg/
m2/day)
A RT* 1.8 GY/day Pelivc Radiation M-F Treat M-F for approx. 5.5 weeks
A Surgery 4-6 weeks following chemoradia-
tion treatment
GI NCCTG GI Committee N0346 - Page 1 of 3
NCCTG Status Report for Study N0346 - September 2007
Arm Agent Dose Route Days Freq
A Capecitabine 1000 mg/m2 (two PO in tow does given am Adjuvant Treat- Q 21 days x 4 cycles
does daily) See & pm (total of 2000 mg/ ment: days 1-14, 7
Table in Section m2/day) days off
7.2
* Radiation, and capecitabine to be given 5 days a week with weekends
off. Capecitabine Friday pm dose will be skipped and Sunday pm dose
taken. Celecoxib will be given concontnuously during concurrent
chemoradiation treatment.
Study Design: The primary endpoint for this study is pathologic CR. The two-stage Simon
design is as follows. Stage 1: enroll 23 patients. If 3 or fewer are successes, then stop the study
while concluding that further investigation of this regimen is not warranted. If 4 or more are
successes, proceed with stage 2. Stage 2: accrue an additional 32 patients (total: 55 patients). If
11 or fewer of the 55 are successes, conclude that further investigation of this regimen is not
warranted. If 12 or more are successes, we may recommend further studies, including possible
Phase III studies.
Accrual: Three patients accrued to this study.
Patient Characteristics: See table.
Adverse Events: Only low grade adverse events have been reported for this study. See table for
more information.
Study Status: Study permanently closed.
Baseline Characteristics Table:
Arm
Characteristics
A
Gender
f 1
m 2
Race
White 1
Black or African American 2
GI NCCTG GI Committee N0346 - Page 2 of 3
NCCTG Status Report for Study N0346 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 3
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology LEUKOPENIA A 1 33 0 0 0 0 0 0
Gastrointestinal NAUSEA A 1 33 0 0 0 0 0 0
FISTULA-RECTAL A 1 33 0 0 0 0 0 0
Maximum Grade Adverse Event A 3 100 0 0 0 0 0 0
GI NCCTG GI Committee N0346 - Page 3 of 3
NCCTG Status Report for Study N0347 - September 2007
Young-Onset Colorectal Cancer: Clinical Characteristics and Intervals for
Recurrence and Survival
Purpose of 1) To ascertain treatment and survival profile differences in individuals with
Study: young-onset colorectal cancer.
Study Chairs: Lisa A. Boardman M.D. QC Specialist:
Statistician: Bruce W. Morlan M.S. Nurse Resource:
Status: 08/22/2003 Activated Projected Number of Patients: 2500
08/22/2003 Perm. Closed
Excluded: None Final Accrual: 3571
Stratification Not applicable.
Factors:
Schema: Not applicable.
Treating Schedule:
Not applicable.
Study Design: This is a database study that enrolled patients from five previous studies
{784852, 844652, 874651, 894651, 914653}.
Accrual: A total of 3571 patients were registered to this protocol.
Patient Characteristics: At this time we have identified approximately 2400 patients from the
five studies who will be used in the analysis.
Adverse Events: This is a retrospective study, so there will be no adverse events.
Study Status: Analysis has focused on correlations between various clinical measures and sur-
vival, with data cleanup a continuing iterative process.
GI NCCTG GI Committee N0347 - Page 1 of 1
NCCTG Status Report for Study N0543 - September 2007
A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin,
and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocar-
cinoma
Purpose of - Primary Goal
Study: 1) To assess the efficacy of the combination of oxaliplatin, irinotecan, and
capecitabine in patients with advanced adenocarcinoma of the small bowel,
when dosed according to UGT1A1 genotype.
- Secondary Goals
1) To assess the toxicity of this regimen in these groups of patients.
2) To gain preliminary data on whether microsatellite instability influences
outcome within this arm.
3) To gain preliminary data on whether evidence of celiac disease may affect
toxicity and outcome.
4) To gain preliminary data on whether site of tumor origin (duodenal, jejunal,
or ileal) affects response or survival.
Study Chairs: Robert R. McWilliams M.D. QC Specialist: Carol A. Leonard
Benjamin T. Marchello M.D.
Statistician: Bruce W. Morlan M.S. Nurse Resource: Gwen Finck R.N., OCN
Status: 05/11/2007 Activated Projected Number of Patients: 33
Stratification None
Schema: Registration
Arm A (6/6 UGT1A1 genotype)
Arm B (6/7 UGT1A1 genotype)
Arm C (7/7 UGT1A1 genotype)
Treating Schedule:
Arm Agent Dose Route Days Freq
A Irinotecan 150 mg/m2 IV over 90 minutes in 500 1 3 weeks
ml NS or D5W
A Oxaliplatin 100 mg/m2 IV over 2 hours in 250 ml 1 3 weeks
D5W after CPT-11
A Capecitabine 1600 mg/m2/day PO, divided twice daily 2-15 3 weeks
(800 mg/m2 two times
daily)
B Irinotecan 150 mg/m2 IV over 90 minutes in 500 1 3 weeks
ml NS or D5W
B Oxaliplatin 85 mg/m2 IV over 2 hours in 250 ml 1 3 weeks
D5W after CPT-11
GI NCCTG GI Committee N0543 - Page 1 of 2
NCCTG Status Report for Study N0543 - September 2007
Arm Agent Dose Route Days Freq
B Capecitabine* 400 mg/m2/day PO, divided twice daily 2-15 3 weeks
(200 mg/m2 two times a
day)
C Irinotecan 75 mg/m2 IV over 90 minutes in 500 1 3 weeks
ml NS or D5W
C Oxaliplatin 85 mg/m2 IV over 2 hours in 250 ml 1 3 weeks
D5W after CPT-11
C Capecitabine* 400 mg/m2/day PO, divided twice daily 2-15 3 weeks
(200 mg/m2 two times a
day)
*Patients on Arms B and C may have dose of capecitabine increased up
to 800 mg/m2 beginning on cycle 2 if no Grade 3 toxicities are
encountered on cycle 1, at discretion of treating physician.
Study Design: This is a two-stage, three-outcome design (Fleming, Goldberg-Sargent) evaluat-
ing the confirmed tumor response within the first 12 cycles of treatment. Stage 1 will accrue 16
evaluable patients. If we see 1 or 0 successes in stage 1 we will conclude that the regimen is not
effective. Otherwise we will continue to accrue an additional 17 patients. If 5 or fewer successes
are observed in the first 33 evaluable patients then we will consider this regimen ineffective. If
there are 7 or more successes we may recommend further testing. If there are exactly 6 successes
we will use other criteria (e.g., patient tolerance) to determine if further study is warranted.
Accrual: No patients have accrued to this study.
Study Status: Study is open.
GI NCCTG GI Committee N0543 - Page 2 of 2
NCCTG Status Report for Study N0041 - September 2007
Phase II Trial of Gemcitabine and Docetaxel in Patients With Measurable
Unresectable or Metastatic Hepatocellular Carcinoma
Purpose of - Primary Goal
Study: 1) To assess confirmed tumor response for this patient population with Gemcit-
abine and Docetaxel.
.
- Secondary Goals
1) To assess the overall survival, time-to-progression, and toxicity for patients
given this treatment regimen.
2) To describe docetaxel pharmacokinetics for this patient population.
Study Chairs: Steven R. Alberts M.D. QC Specialist: Deborah J. Papenfus
Loren K. Tschetter M.D. CCRP
Statistician: Bruce W. Morlan M.S. Nurse Resource: Colleen Sweetland R.N.
Status: 09/28/2001 Activated Projected Number of Patients: 44
11/28/2003 Perm. Closed
Excluded: None Final Accrual: 25
Stratification None
Schema: Register
Gemcitabine + Docetaxel
Treating Schedule:
Arm Agent Dose Route Days Freq
A Docetaxel 30 mg/m2 IV infusion over 60 min 1, 8 Every 21 days
A Gemcitabine 800 mg/m2 IV over 30 min following 1, 8 Every 21 days
Docetaxel
Study Design: The primary endpoint of this trial is confirmed tumor response. At least 5 con-
firmed tumor responses (i.e. CR or PR) in 40 evaluable patients is considered sufficient evidence
or promising activity. However, if at most one confirmed response is observed at the planned
interim analyses (i.e. 22 evaluable patients), we will terminate accrual at that time. Accrual will
not be suspended unless an unexpectedly high accrual rate or excessive toxicity are observed.
Accrual: This study accrued 25 patients. See Accrual Table for further details.
GI NCCTG GI Committee N0041 - Page 1 of 4
NCCTG Status Report for Study N0041 - September 2007
Patient Characteristics: At study entry, 13 patients had a performance score (PS) of 0, 10 had
a PS of 1, and 2 had a PS of 2. The distribution of patient characteristics at study entry is located
in the Patient Characteristics Table.
Available Information: All patients are considered eligible.
Adverse Events: All 25 patients are evaluable for toxicity analyses. Two patients experienced
grade 5 adverse events (Hepatic Failure and Renal Failure), both of which were thought to be
unrelated to the study medication. Eleven patients have experienced at least one grade 4
adverse event. See the Adverse Events section of the 2002 NCCTG book for information about
why the study was suspended for a time. For more detailed information about the adverse event
data, see the Adverse Event Table.
Study Status: The study was permanently closed to accrual due to slow accrual, toxicity and
poor performance. Pharmacokinetics analyses are underway.
Additional Information: An abstract was submitted to ASCO 2004, which can be found in the
Spring 2004 book report. A manuscript summarizing the information is being written.
Accrual Table:
Randomizing Total
Membership Entered
Atlanta 2
Carle 3
Duluth 1
Jacksonville 2
Mayo 5
Mo Valley 1
Scottsdale 6
Sioux Falls 1
Wichita 4
Total Membership Accrual 25
Baseline Characteristics Table:
Arm
Characteristics
A
Cirrhosis
Yes 9
No 16
Current Disease Status
GI NCCTG GI Committee N0041 - Page 2 of 4
NCCTG Status Report for Study N0041 - September 2007
Arm
Characteristics
A
Hepatic 14
Extrahepatic 11
Gender
f 8
m 17
Hepatitis Type
15
Viral hepatitis (hepatitis B, C, other) 6
Hemachromatosis 1
Alcoholic cirrhosis 3
History of Hepatitis
Yes 10
No 15
Prior Chemoembolization
7
No 18
Race
White 19
Black or African American 1
Asian 2
American Indian or Alaska Native 1
Not reported: patient refused or not ava 2
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 24
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N
% N % N % N %
Hematology NEUTROPENIA A 9 38 7 29 6 25 0 0
LEUKOPENIA A 2 8 6 25 2 8 0 0
ANEMIA A 9 38 1 4 0 0 0 0
LYMPHOPENIA A 1 4 2 8 0 0 0 0
THROMBOCYTOPENIA A 13 54 7 29 0 0 0 0
LEUKOPENIA-BMT A 0 0 0 0 1 4 0 0
Cardiovascular EDEMA A 5 21 2 8 1 4 0 0
Constitutional Symptoms FATIGUE A 16 67 3 13 1 4 0 0
Dermatology/Skin ALOPECIA A 11 46 0 0 0 0 0 0
PRURITIS A 4 17 0 0 0 0 0 0
RASH A 10 42 1 4 0 0 0 0
Gastrointestinal ANOREXIA A 4 17 3 13 0 0 0 0
GI NCCTG GI Committee N0041 - Page 3 of 4
NCCTG Status Report for Study N0041 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
NAUSEA A 8 33 1 4 0 0 0 0
STOMATITIS A 5 21 2 8 0 0 0 0
DEHYDRATION A 2 8 2 8 0 0 0 0
VOMITING A 4 17 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 5 21 4 17 0 0 0 0
Hepatic HEPATIC FAILURE A 0 0 0 0 0 0 1 4
SGOT (AST) A 8 33 3 13 0 0 0 0
SGPT (ALT) A 5 21 0 0 0 0 0 0
ALK PHOS A 4 17 0 0 0 0 0 0
Infection/Febrile Neutropenia INFECTION-NO ANC A 5 21 1 4 0 0 0 0
FEBRILE NEUTROPENIA A 0 0 2 8 1 4 0 0
Metabolic/Laboratory HYPOCALCEMIA A 2 8 2 8 0 0 0 0
HYPONATREMIA A 2 8 4 17 0 0 0 0
HYPERGLYCEMIA A 3 13 1 4 0 0 0 0
Neurology ATAXIA A 0 0 0 0 1 4 0 0
NEURO-SENSORY A 9 38 0 0 0 0 0 0
Pain ARTHRALGIA A 2 8 1 4 0 0 0 0
PAIN-ABDOMINAL A 5 21 1 4 0 0 0 0
Pulmonary DYSPNEA A 2 8 2 8 1 4 0 0
Renal /Genitourinary CREATININE A 2 8 2 8 0 0 0 0
RENAL FAILURE A 0 0 1 4 0 0 1 4
URETERAL OBSTRUCTION A 0 0 0 0 1 4 0 0
Maximum Grade Adverse Event A 5 21 9 38 8 33 2 8
GI NCCTG GI Committee N0041 - Page 4 of 4
NCCTG Status Report for Study N0342 - September 2007
A Phase II Study of Maintenance ZD1839 (Iressa) in Patients with Locally
Advanced Esophageal Cancer after Treatment Given with Curative Intent
Purpose of - Primary
Study: - To evaluate the one-year overall survival rate with ZD1839 as a single agent
after potentially curative therapy (either surgery or chemotherapy + radia-
tion or chemotherapy + radiation + surgery) for locally advanced esophageal
cancer.
- Secondary
1) To explore disease-free survival, time to disease recurrence, characterization
of toxicity and quality of life within this cohort.
2) To explore quality of life based on type of potentially curative treatment pre-
scribed prior to trial entry.
Study Chairs: Aminah Jatoi M.D. QC Specialist: Deborah J. Papenfus
Edward J. Wos D.O. CCRP
Statistician: Nathan R. Foster M.S. Nurse Resource: Kathie A. Kindred R.N.
Status: 07/15/2005 Activated Projected Number of Patients: 72
08/04/2006 Perm. Closed
Excluded: None Final Accrual: 5
Stratification None
Factors:
Schema: Register
ZD1839
Treating Schedule:
Arm Agent Dose Route Days Freq
- ZD1839 250 mg P.O. Every Day After 4 weeks and every 12 weeks
thereafter.
Antacids should not be used within 4 hours prior to or after
administration of ZD1839.
GI NCCTG GI Committee N0342 - Page 1 of 4
NCCTG Status Report for Study N0342 - September 2007
Study Design: The primary endpoint of this trial is the 1-year overall survival rate. Any patient
who lives for at least 1 year will be considered a success. The largest success proportion where
the proposed treatment regimen would be considered ineffective in this population is 60%, and
the smallest success proportion that would warrant subsequent studies is 75%. The following 1-
stage Simon Optimal design with an interim analysis uses 26 or 66 patients to test the null
hypothesis that the true success proportion in this patient population is at most 60%.
Interim Analysis: After the first 26 patients become evaluable for 6 month survival, an interim
analysis will be performed. If 20 or fewer of these 26 patients live at least 6 months, we will ter-
minate accrual and conclude the regimen is insufficiently active in this patient population. If 21
or more of these 26 patients live at least 6 months, we will continue accrual to the full 66
patients. Based on the standard 1-year survival decision rules, conservative 6-month decision
rules were determined by assuming the survival function follows an exponential model. Using
6-month survival as the endpoint at the interim analysis allows us to conduct the interim analy-
sis sufficiently early to allow action prior to full enrollment. It also has the advantage of not
exposing as many patients toa potentially harmful treatment if the regimen has limited activity.
Final Analysis: Enter an additional 40 patients into the study. If 44 or fewer successes are
observed in the first 66 evaluable patients, we will consider this regimen ineffective in this
patient population and terminate the study. Forty-five or more successes observed in the first 66
evaluable patients will be considered adequate evidence of efficacy and may be recommended
for further testing in subsequent studies.
Through a simulation study, the power was estimated to be 82% if the true success proportion
was 75%. In addition, the significance level was shown to equal .08 for this study.
Accrual: This study opened on July 15, 2005. Five patients were accrued. See the Accrual
table for more information.
Patient Characteristics: Of the 5 patients that were accrued to the study, three have a PS of 0,
and two have a PS of 1. See the Baseline Characteristics table for information on other baseline
factors.
Available Information: All patients are eligible so far.
Adverse Events: Five patient are evaluable for adverse events. Only one patient experienced
any grade 3+ adverse events. See the Adverse Event Table for further information on the
patients.
Study Status: This study is closed due to accrual issues as of August 4, 2006. Two patients are
still receiving treatment as of August 7, 2007.
GI NCCTG GI Committee N0342 - Page 2 of 4
NCCTG Status Report for Study N0342 - September 2007
Accrual Table:
Randomizing Total
Membership Entered
Des Moines 2
Lehigh 1
Mayo 2
Total Membership Accrual 5
Baseline Characteristics Table:
Arm
Characteristics
A
Chemo And Radiation Given
Yes 4
No 1
Gender
f 1
m 4
Last treatment
Surgery 1
Chemotherapy + radiation + surgery 4
Lymph Node Involvement
Yes 3
No 2
Race
White 5
Tumor Stage
T3 5
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 5
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Constitutional Symptoms FATIGUE A 1 20 1 20 0 0 0 0
Dermatology/Skin RASH A 4 80 0 0 0 0 0 0
Gastrointestinal NAUSEA A 2 40 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 3 60 0 0 0 0 0 0
Infection/Febrile Neutropenia PNEUMONIA NOS A 1 20 0 0 0 0 0 0
Ocular/Visular DRY EYE A 1 20 0 0 0 0 0 0
GI NCCTG GI Committee N0342 - Page 3 of 4
NCCTG Status Report for Study N0342 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Pain PAIN-ABDOMINAL A 2 40 0 0 0 0 0 0
Pulmonary DYSPNEA A 1 20 0 0 0 0 0 0
Maximum Grade Adverse Event A 3 60 1 20 0 0 0 0
GI NCCTG GI Committee N0342 - Page 4 of 4
NCCTG Status Report for Study N0349 - September 2007
Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam
Radiation Followed by Gemcitabine in Patients with Locally Advanced Pan-
creatic Cancer
Purpose of 1) The primary goal of this study is to evaluate the 1-year survival rate in
Study: patients with locally advanced pancreatic cancer receiving oxaliplatin and
continuous infusion 5-fluorouracil administered concurrently with external
beam radiation, followed by 3 months of maintenance gemcitabine adminis-
tered weekly (2 wks then 1 wk rest).
2) Secondary endpoints include overall survival, time to disease progression,
confirmed response rate, and toxicity.
Study Chairs: George P. Kim M.D. QC Specialist: Deborah J. Papenfus
John W. Bollinger M.D. CCRP
Statistician: Nathan R. Foster M.S. Nurse Resource: Linda Arneson R.N.
Status: 12/17/2004 Activated Projected Number of Patients: 50
05/05/2006 Perm. Closed
Excluded: 2 Final Accrual: 55
Stratification None
Factors:
Schema: Register
Simultaneous RT + 5FU + OXAL
Gemcitabine
Treating Schedule:
Arm Agent Dose Route Days Freq
Oxaliplatin 85 mg/m2 IV over 2 hours in 250 ml 1, 15, 29 of radia- Every 2 weeks
D5W tion therapy
5FU 180 mg/m2 per Continuous IV (Starting Starting D1 of RT Starting D1, then q day throught
day within 24 hrs of RT initia- last day of RT
tion)
Gemcitabine 1000 mg/m2 IV over 30 minutes in 250 1, 8 (Starting 4-6 Q 2 weeks x 4 cycles (12 wks
ml NS wks following total)
chemoradiation)
RT 180 cGy x 28 frac- Initial Field=4500 cGy M-F M-F for 5.5 weeks
tions total and Boost Field=540
cGy total
GI NCCTG GI Committee N0349 - Page 1 of 5
NCCTG Status Report for Study N0349 - September 2007
Study Design: The primary endpoint of this trial is the 12-month survival rate. Any patient
who lives for at least 12 months will be considered a success. The largest sucess proportion
where the proposed treatment regimen would be considered ineffective in this population is
40%, and the smallest success proportion that would warrant subsequent studies is 60%. The
following 1-stage Fleming design with an interim analysis uses 15 or 45 patients to test the null
hypothesis that the true success proportion in this patient population is at most 40%.
Interim Analysis: After the first 15 patients become evaluable for 6-month survival, an interim
analysis will be performed. If 9 or fewer of these 15 patients live at least 6 months, we will ter-
minate accrual and conclude the regimen is insufficiently active in this patient population. If 13
or more of these 15 patients live at least 6 months, we will conclude that the regimen has suffi-
cient activity to warrant further testing. If 10 to 12 of these 15 patients live at least 6 months, we
will continue accrual to the full 45 patients. Based on the standard 1-year survival decision rules,
conservative 6-month decision rules were determined by assuming the survival function follows
an exponential model. Using 6-month survival as the endpoint at the interim analysis allows us
to conduct the interim analyis sufficiently early to allow action prior to full enrollment. It also
has the advantage of not exposing as many patients to a potentially harmful treatment if the reg-
imen has limited activity.
Final Analysis: Enter an additional 30 patients into the study. If 22 or fewer successes are
observed in the first 45 evaluable patients, we will consider this regimen ineffective in this
patient population and terminate this study. Twenty-three or more successes observed in the
first 45 evaluable patients will be considered adequate evidence of efficacy and may be recom-
mended for further testing in subsequent studies.
Through a simulation study, the power was estimated to be 85% if the true success proportion
was 60%. In addition, the significance level was shown to equal .10 for this study.
Accrual: This study opened on December 17, 2004, and accrued 55 patients.
Patient Characteristics: Of the 55 patients accrued, 27 have a PS of 0 and 28 have a PS of 1.
See the Baseline Characteristics Table for more information.
Available Information: One patient cancelled out of the 55 accrued. As of December 2006, 5
patients have been entered and reviewed as part of the Radiation Quality Control Process. Of
these 5 patients, 0% had minor deviations and 0% had major deviations.
GI NCCTG GI Committee N0349 - Page 2 of 5
NCCTG Status Report for Study N0349 - September 2007
Adverse Events: Fifty-three patients are evaluable so far for adverse events. Of these 53
patients, 50 (94%) have experienced at least one grade 3+ adverse event and 11 (21%) have
experienced at least one grade 4+ adverse event. One patient expired at home due to an
unknown cause and so this patient is listed as Death Not Otherwise Specified (NOS) in the
table. This death was listed as not related to the study medication. One other patient died due to
cardiac arrest and is listed in the attached table as sudden death. This death occurred at home
and is listed as possibly related to the study treatment. See the adverse event table for more
information.
Study Status: Trial is closed due to meeting accrual requirements as of May 5, 2006. As of
February 15, 2007, all patients are off treatment.
A poster was presented at the January 2007 Gastrointestinal Cancers Symposium in Orlando,
FL. The accepted abstract for this conference is attached.
Accrual Table:
Randomizing Total
Membership Entered
Allegheny WP 2
Ann Arbor 16
Des Moines 4
Geisinger 3
Grand Forks 2
Hawaii CCOP 2
Jacksonville 2
MN CGOP 3
Mayo 6
Peoria 5
Scottsdale 3
Sioux Falls 1
Upstate Carol 2
Wichita 4
Total Membership Accrual 55
Baseline Characteristics Table:
Arm
Characteristics
A
Gender
f 24
m 31
Method Of Diagnosis
Percutaneous Biopsy 13
Endoscopic Biopsy 28
GI NCCTG GI Committee N0349 - Page 3 of 5
NCCTG Status Report for Study N0349 - September 2007
Arm
Characteristics
A
Open Biopsy at Laparotomy 14
Nodal Status
POSITIVE 17
NEGATIVE 38
Nodal Status Method
Clinical 38
Pathologic 17
Race
White 51
Black or African American 2
Asian 2
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 53
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 13 25 13 25 1 2 0 0
LEUKOPENIA A 20 38 14 26 1 2 0 0
ANEMIA A 41 77 3 6 0 0 0 0
THROMBOCYTOPENIA A 29 55 3 6 0 0 0 0
Cardiovascular HYPOTENSION A 1 2 2 4 1 2 0 0
ATRIAL FIBRILLATION A 0 0 0 0 1 2 0 0
Constitutional Symptoms FATIGUE A 31 58 19 36 1 2 0 0
FEVER-NO ANC A 9 17 2 4 0 0 0 0
WEIGHT LOSS A 12 23 2 4 0 0 0 0
Dermatology/Skin ALOPECIA A 14 26 0 0 0 0 0 0
Gastrointestinal ANOREXIA A 32 60 16 30 0 0 0 0
NAUSEA A 35 66 15 28 0 0 0 0
DYSPHAGIA A 1 2 0 0 1 2 0 0
STOMATITIS A 9 17 1 2 0 0 0 0
DEHYDRATION A 12 23 5 9 1 2 0 0
CONSTIPATION A 11 21 0 0 0 0 0 0
VOMITING A 31 58 9 17 0 0 0 0
DIARRHEA-NO COLOSTOM A 29 55 11 21 0 0 0 0
Oral cavity MS CE A 15 28 2 4 0 0 0 0
Hemorrhage ESOPHAG HEMORR A 0 0 0 0 1 2 0 0
PANCR HEMORR A 0 0 0 0 1 2 0 0
UPR GI HEMORR A 0 0 0 0 2 4 0 0
Hepatic SGOT (AST) A 11 21 3 6 0 0 0 0
GI NCCTG GI Committee N0349 - Page 4 of 5
NCCTG Status Report for Study N0349 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
SGPT (ALT) A 9 17 3 6 0 0 0 0
HYPOALBUMINEMIA A 7 13 6 11 0 0 0 0
BILIRUBIN A 7 13 6 11 1 2 0 0
Infection/Febrile Neutropenia OPPORTUNISIT INFECT A 0 0 0 0 1 2 0 0
Metabolic/Laboratory HYPOCALCEMIA A 11 21 1 2 0 0 0 0
HYPONATREMIA A 4 8 4 8 0 0 0 0
HYPOKALEMIA A 5 9 5 9 1 2 0 0
LIPASE A 0 0 0 0 1 2 0 0
HYPERGLYCEMIA A 13 25 5 9 1 2 0 0
ALK PHOSPHATASE A 9 17 6 11 0 0 0 0
Neurology DIZZINESS A 2 4 0 0 1 2 0 0
NEURO A 34 64 1 2 0 0 0 0
Pain PAIN-ABDOMINAL A 12 23 5 9 0 0 0 0
Pulmonary DYSPNEA A 15 28 2 4 0 0 0 0
Death DEATH NOS A 0 0 0 0 0 0 1 2
SUDDEN DEATH A 0 0 0 0 0 0 1 2
Vascular VASC ACCESS COMPLIC A 1 2 0 0 2 4 0 0
Maximum Grade Adverse Event A 3 6 39 74 9 17 2 4
GI NCCTG GI Committee N0349 - Page 5 of 5
NCCTG Status Report for Study N034A - September 2007
Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Met-
astatic Pancreatic Adenocarcinoma
Purpose of 1) Primary endpoint: To evaluate the 6-month survival of the combination of
bevacizumab gemcitabine and oxaliplatin in previously untreated patients
with metastatic pancreatic adenocarcinoma.
Study: 2) Secondary endpoints: To estimate objective response rates (only in patients
with measurable disease), median survival, progression-free survival, time
to treatment failure, overall survival and toxicity in these treated patients.
3) Translational Studies: To study markers predictive of benefit from chemo-
therapy.
Study Chairs: George P. Kim M.D. QC Specialist: Deborah J. Papenfus
CCRP
Statistician: Nathan R. Foster M.S. Nurse Resource: Linda Arneson R.N.
Status: 05/19/2006 Activated Projected Number of Patients: 83
Perm. Closed
Excluded: 5 Final Accrual: 84
Stratification None
Factors:
Schema: Register
Bevacizumab + Gemcitabine + Oxaliplatin
Treating Schedule:
Arm Agent Dose Route Days Freq
- Gemcitabine 1000 mg/m2 100-minute IV infusion in 1 and 15 Every 28 days
250 ml NS
- Bevacizumab 10 mg/kg 90 minutes IV infusion 1 and 15 Every 28 days
during initial treatment
- Oxaliplatin 100 mg/m2 120-minute IV infusion in 2 and 16 Every 28 days
250 ml D5W
Patients who have had recent surgery or trauma (10% 4
Tumor Histology
Squamous 2
Adenocarcinoma 19
Missing 1
Tumor Site
Esophagus 8
Gastroesophageal Junction 13
Missing 1
GI NCCTG GI Committee N044E - Page 3 of 4
NCCTG Status Report for Study N044E - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 15
Maximum Severity Per Patient
Body System Adverse Event Arm Grade 1/2 Grade 3 Grade 4 Grade 5
N % N % N % N %
Hematology NEUTROPENIA A 9 60 2 13 1 7 0 0
LEUKOPENIA A 9 60 2 13 1 7 0 0
ANEMIA A 12 80 0 0 0 0 0 0
THROMBOCYTOPENIA A 11 73 0 0 0 0 0 0
Gastrointestinal NAUSEA A 9 60 1 7 0 0 0 0
DYSPHAGIA A 7 47 0 0 0 0 0 0
DYSPHAGIA-PHARYN A 10 67 0 0 0 0 0 0
RT
VOMITING A 2 13 1 7 0 0 0 0
ESOPHAG MS CE A 4 27 0 0 0 0 0 0
ESOPHAG MS FS A 4 27 1 7 0 0 0 0
Pain PAIN-ESOPHAGEAL A 4 27 0 0 0 0 0 0
Maximum Grade Adverse Event A 8 53 6 40 1 7 0 0
GI NCCTG GI Committee N044E - Page 4 of 4
NCCTG Status Report for Study N044J - September 2007
A Phase II Study of AZD2171 in Patients with Locally Advanced or Metastatic
Hepatocellular Carcinoma
Purpose of - Primary Goal
Study: 1) To assess six-month survival in patients with locally advanced or metastatic
HCC treated with AZD2171.
- Secondary Goals
1) To assess tumor reponse, time-to-progression and toxicity in patients with
locally advanced or metastatic HCC treated with AZD2171.
2) To assess defined biological markers in hepatocellular carcinoma patients
treated with AZD2171 as surrogate markers of response, including:
* Circulating VEGF, soluble VEGFR1 (sFLT-1), VEGFR-2 (KDR) levels, and
plasma angiogenic activity.
* VEGFR1 (FLT-1), VEGFR-2 (KDR), both total and phosphorylated, as well
as microvessel density (CD31) and tumor proliferation (Ki-67) tumor tissue
expression.
* PLVAP tumor tissue expression.
Study Chairs: Steven R. Alberts M.D. QC Specialist: Carla R. Hilton
Robert F. Marschke Jr M.D.
Statistician: Bruce W. Morlan M.S. Nurse Resource: Colleen Sweetland R.N.
Status: 12/16/2005 Activated Projected Number of Patients: 44
Excluded: None Final Accrual: NA
Stratification None
Factors:
Schema: Reg
AZD2171
Treating Schedule:
Arm Agent Dose Route Days Freq
- AZD2171 45 mg by mouth once daily 1-28 Every 4 weeks
GI NCCTG GI Committee N044J - Page 1 of 4
NCCTG Status Report for Study N044J - September 2007
Study Design: This study will assess the efficacy AZD2171 in patients with locally advanced or
metastatic hepatocellular carcinoma using a two-stage Fleming, phase II study design. The pri-
mary endpoint of this trial is the 6-month survival rate. STAGE 1: Enter 20 patients into the
study. If 8 or fewer successes are observed in the first 20 evaluable patients, we will consider
this regimen ineffective in this patient population and terminate this study. If 13 or more suc-
cesses are observed in the first 20 evaluable patients, we may terminate accrual and may recom-
mend further testing of this regimen in subsequent studies in this patient population. Otherwise,
if the number of successes is 9-12 we will proceed to Stage 2. Stage 2: Enter an additional 20
patients into the study. If 21 or fewer successes are observed in the first 40 evaluable patients,
we will consider this regimen ineffective in this patient population. If 22 or more successes are
observed in the first 40 evaluable patients, we may recommend further testing of this regimen in
subsequent studies in this population.
Accrual: When the data was frozen for this report on August 6, 2007, this study had accrued 28
patients. See accrual table for more details.
Patient Characteristics: The distribution of patient characteristics at study entry is located in
the Baseline Characteristics Table.
Adverse Events: There were 28 patients reporting adverse events at the time of this report.
There have been grade 3+ adverse events in 26 patients (93%). The most common grade 3
adverse events were fatigue (43%), anorexia (25%), and hypertension (21%). Five patients expe-
rienced grade 4+ adverse events. Three patients experienced grade 4 events that were thought to
be at least possibly related to treatment. Two patients experienced a grade 5 event but neither
was thought to be at least possibly related to treatment. Please see the Adverse Event Table for
more details.
Study Status: We have elected to close the study permanently because too few patients were
able to tolerate the treatment regime long enough to attribute success to the treatment. The
median number of cycles received overall was 2 with 10 of the first 20 patients receiving only
one cycle of treatment.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Carle 1 0 0
Dayton 3 0 0
Green Bay 1 0 0
Jacksonville 4 0 0
Lehigh 2 0 0
MN CGOP 1 0 1
GI NCCTG GI Committee N044J - Page 2 of 4
NCCTG Status Report for Study N044J - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Mayo 8 0 1
Metro MN 1 0 1
Rapid City 1 0 0
Scottsdale 1 0 0
St. Cloud 1 0 1
Wichita 4 0 1
Total Membership Accrual 28 0 5
Baseline Characteristics Table:
Arm
Characteristics
A
Cirrhosis
Yes 15
No 13
Current Disease Status
Hepatic 11
Extrahepatic 17
Gender
Female 3
Male 25
Hepatitis Type
16
Viral hepatitis (hepatitis B, C, other) 9
Hemachromatosis 1
Alcoholic cirrhosis 2
History of Hepatitis
Yes 12
No 16
Prior Chemoembolization
Yes 9
No 19
Race
White 25
Black or African American 2
Asian 1
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 28
GI NCCTG GI Committee N044J - Page 3 of 4
NCCTG Status Report for Study N044J - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 6 21 1 4 0 0 0 0
ANEMIA A 2 7 0 0 1 4 0 0
THROMBOCYTOPENIA A 14 50 0 0 0 0 0 0
Cardiovascular HYPERTENSION A 9 32 6 21 0 0 0 0
VALVULAR HRT DISEASE A 0 0 0 0 1 4 0 0
Constitutional Symptoms FATIGUE A 13 46 12 43 1 4 0 0
WEIGHT LOSS A 4 14 2 7 0 0 0 0
Gastrointestinal ANOREXIA A 9 32 7 25 0 0 0 0
NAUSEA A 10 36 4 14 0 0 0 0
STOMATITIS A 1 4 3 11 0 0 0 0
DEHYDRATION A 3 11 3 11 1 4 0 0
TASTE A 3 11 0 0 0 0 0 0
VOMITING A 3 11 2 7 0 0 0 0
DIARRHEA-NO COLOSTOM A 9 32 3 11 0 0 0 0
Hepatic SGOT (AST) A 6 21 3 11 1 4 0 0
SGPT (ALT) A 0 0 4 14 1 4 0 0
BILIRUBIN A 4 14 3 11 0 0 0 0
Infection/Febrile Neutropenia LIVER INFECTN A 0 0 0 0 1 4 0 0
Metabolic/Laboratory HYPOGLYCEMIA A 0 0 0 0 1 4 0 0
HYPONATREMIA A 2 7 3 11 0 0 0 0
ALK PHOSPHATASE A 6 21 0 0 0 0 0 0
Neurology NEURO-SENSORY A 7 25 0 0 0 0 0 0
CONFUSION STATE A 4 14 2 7 0 0 0 0
Pain PAIN-ABDOMINAL A 5 18 4 14 0 0 0 0
Pulmonary DYSPNEA A 3 11 1 4 0 0 0 0
Renal /Genitourinary PROTEINURIA A 8 29 1 4 0 0 0 0
CREATININE A 4 14 1 4 0 0 0 0
Death DISEASE PROGRESSION A 0 0 0 0 0 0 2 7
Maximum Grade Adverse Event A 2 7 21 75 3 11 2 7
GI NCCTG GI Committee N044J - Page 4 of 4
NCCTG Status Report for Study N9943 - September 2007
Phase I/II Trial of Gemcitabine and ALIMTA in Patients with Measurable or
Evaluable, Unresectable or Metastatic Biliary Tract Carcinoma (Intrahepatic,
Extrahepatic, Ampulla of Vater) and Gallbladder Carcinoma
Purpose of - Primary Endpoint:
Study: 1) To evaluate the following in patients with unresectable or metastatic biliary
tract and gallbladder carcinomas that have been treated with the combina-
tion of fixed rate infusion GEMZAR and ALIMTA: dose-MTD).
- Secondary Endpoints:
1) Evaluate the best objective tumor response rate, duration of best objective
tumor response, time-to-progression, overall survival, and toxicities associ-
ated with the combination of GEMZAR and ALIMTA.
2) Evaluate the polymorphisms that may effect the metabolism of GEMZAR.
3) Assess individual patient variation in clinical (toxicity and/or responses to
GEMZAR and ALIMTA) due to genetic differences in proteins involved in
drug response (transport, metabolism and mechanism of action).
Study Chairs: Steven R. Alberts M.D. QC Specialist: Deborah J. Papenfus
Jonathan R. Sande M.D. CCRP
Statistician: Nathan R. Foster M.S. Nurse Resource: Colleen Sweetland R.N.
Status: 09/14/2004 Activated Projected Number of Patients: 86
08/25/2006 Perm. Closed
Excluded: 5 Final Accrual: 68
Stratification Grouping Factor: Phase I vs. II
Factors:
Schema: Register
A) Gemzar + Alimta
Treating Schedule:
Arm Agent Dose Route Days Freq
A ALIMTA 500 mg/m2 IV in 100ml NS over 10 1 and 15 Q 4 weeks
minutes
A GEMZAR Ph I:Dose level 30 mins after Alimta 1 and 15 Q 4 weeks
assigned by Ran- comp; IV in 250ml NS at
dom Center; PhII: 10mg/m2/minute
TBD
Creatinine clearance MUST BE >=45 mL/min before ANY Alimta is given.
Enrollment will start with dose level 2.
GI NCCTG GI Committee N9943 - Page 1 of 5
NCCTG Status Report for Study N9943 - September 2007
Study Design: Phase I Design: We will use a standard Phase I design that evaluates the MTD
based on the dose-limiting adverse events observed in patients enrolled from this population,
according to a dose escalation scheme, in cohorts of 3.
Phase II Study Design: The primary endpoint of this phase of the trial is the proportion of
patients alive at 6 months post-registration. A treatment success will be defined as a patient liv-
ing at least 6 months post-registration. All eligible patients initiating treatment will be consid-
ered evaluable for the primary endpoint. This phase II portion uses a one-stage design with an
interim analyses and yields 92% power if the 6-month survival rate (6MSR) is 65%, with a level
of significance of 5% assuming the null hypothesis 6MSR is 45%.
Interim Analysis: An interim analysis will be performed when the 24th patient becomes evalu-
able at the phase II dose level. If 11 or fewer successes are observed in the first 24 evaluable
patients, we will consider this regimen ineffective in this patient population. Otherwise, if at
least 12 successes are observed in 24 evaluable patients, we will continue enrollment to a maxi-
mum of 59 evaluable patients.
Final Analysis: Enter an additional 35 patients into the study. If 32 or fewer successes are
observed in the first 59 evaluable patients, we will consider this regimen ineffective in this
patient population. Otherwise, if 33 or more successes are observed in the first 59 evaluable
patients, we may recommend further testing of this regimen in subsequent studies in this popula-
tion.
Accrual: This study opened on 03/05/2004 and accrued 68 total patients. The study was perma-
nently closed on 08/25/2006.
Patient Characteristics: At baseline, 32 patients had a performance score (PS) of 0, 32 patients
had a PS of 1, and 4 patients had a PS of 2. See Patient Characteristics table for information on
other baseline factors of interest.
Available Information: Five patients have cancelled out of the 68 total patients.
Adverse Events: Sixty-one patients are evaluable for adverse events. Of these 61 patients, 58
(95%) experienced at least one grade 3+ adverse event and 34 (56%) experienced at least one
grade 4+ adverse event. One patient died from a grade 5 Renal Failure. This event was possibly
related to the study medication and occurred at the dose level just above the MTD. Another
patient expired due to a hemorrhage that was thought to be caused by a fall and was deemed not
related to study treatment. Another patient suffered a grade 5 pulmonary which was thought to
be brought on by a complication with a stent and was deemed not related to study treatment. For
further details, see the adverse event table.
GI NCCTG GI Committee N9943 - Page 2 of 5
NCCTG Status Report for Study N9943 - September 2007
Study Status: This study is currently closed as of August 25, 2006. This study accrued 12
patients to the Phase I portion and accrued 56 patients to the Phase II portion. The MTD deter-
mined during the Phase I portion was Dose Level 1 (Gemzar 800 mg/m2 and Alimta = 500 mg/
m2).
A poster was presented at the 2007 Gastrointestinal Cancers Symposium in Orlando, FL.
A poster was also presented at the ASCO 2007 conference in Chicago, IL. The submitted
abstract is attached.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Atlanta 2 0 0
Bismarck 2 0 0
Cedar Rapids 2 0 0
Duluth 1 0 0
Geisinger 1 0 0
Green Bay 4 0 0
Heartland 1 0 1
Jacksonville 3 0 0
Lehigh 4 0 0
Mayo 27 0 1
Metro MN 3 0 0
Mo Valley 1 0 0
Peoria 5 0 0
Scottsdale 5 0 0
Sioux City 3 0 0
Upstate Carol 3 0 0
Wichita 1 0 0
Total Membership Accrual 68 0 2
Baseline Characteristics Table:
Arm
Characteristics
A
Disease Status
Locally advanced 6
Metastatic 62
Gender
f 36
m 32
Group
Phase I 12
Phase II 56
Previous Radiation Therapy
GI NCCTG GI Committee N9943 - Page 3 of 5
NCCTG Status Report for Study N9943 - September 2007
Arm
Characteristics
A
Yes 5
No 63
Primary Tumor Site
Gallblader 18
Billiary (intrahepatic) 30
Billiary (extrahepatic) 16
Ampulla of Vater 4
Prior Chemotherapy
Yes 5
No 63
Prior Other Therapy
Yes 1
No 67
Race
White 64
Black or African American 3
Not reported: patient refused or not ava 1
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 61
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 9 15 16 26 28 46 0 0
LEUKOPENIA A 6 10 11 18 4 7 0 0
ANEMIA A 13 21 4 7 1 2 0 0
THROMBOCYTOPENIA A 29 48 6 10 1 2 0 0
Cardiovascular THROMBOSIS A 0 0 4 7 2 3 0 0
Constitutional Symptoms FATIGUE A 19 31 15 25 0 0 0 0
Dermatology/Skin ALOPECIA A 24 39 0 0 0 0 0 0
RASH A 21 34 0 0 0 0 0 0
Gastrointestinal NAUSEA A 37 61 7 11 0 0 0 0
STOMATITIS A 19 31 0 0 0 0 0 0
DEHYDRATION A 2 3 6 10 0 0 0 0
VOMITING A 20 33 3 5 0 0 0 0
DIARRHEA-NO COLOSTOM A 13 21 2 3 0 0 0 0
Hemorrhage HEMORRHAGE A 0 0 0 0 0 0 1 2
Hepatic ALK PHOS A 5 8 6 10 1 2 0 0
BILIRUBIN A 0 0 2 3 1 2 0 0
Infection/Febrile Neutropenia FEBRILE NEUTROPENIA A 0 0 6 10 1 2 0 0
GI NCCTG GI Committee N9943 - Page 4 of 5
NCCTG Status Report for Study N9943 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Metabolic/Laboratory HYPONATREMIA A 0 0 2 3 1 2 0 0
HYPERGLYCEMIA A 2 3 4 7 1 2 0 0
Neurology CONFUSION A 0 0 1 2 1 2 0 0
Pain PAIN-ABDOMINAL A 3 5 6 10 1 2 0 0
Pulmonary DYSPNEA A 3 5 7 11 0 0 0 0
ARDS A 0 0 0 0 1 2 0 0
PULMONARY A 0 0 0 0 0 0 1 2
Renal /Genitourinary RENAL FAILURE A 0 0 0 0 0 0 1 2
Maximum Grade Adverse Event A 3 5 24 39 31 51 3 5
GI NCCTG GI Committee N9943 - Page 5 of 5
NCCTG Status Report for Study 80101 - September 2007
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of
Gastric or Gastroesophageal Adenocarcinoma
Purpose of - Primary
Study: 1) To determine whether overall survival is prolonged in patients with resected
gastric adenocarcinoma who receive epirubicin, cisplatin, and infusional 5-
FU (ECF) before and after infusional 5-FU plus radiotherapy (RT) when
compared to those treated with bolus 5-FU and leucovorin before and after
infusional 5-FU plus RT.
- Secondary
1) To determine whether disease-free survival as well as local and distant
recurrence rates are prolonged in patients with resected gastric adenocarci-
noma who receive epirubicin, cisplatin, and infusional 5-FU (ECF) before
and after infusional 5-FU plus radiotherapy (RT) when compared to those
treated with bolus 5-FU and leucovorin before and after infusional 5-FU
plus RT.
2) To prospectively assess whether the expression of putative prognostic mark-
ers in the tumor (including TS, ERCC-1, MSI, E-cadherin, EGFR, p27,
COX-2, c-erbB-2) correlate with overall survival.
3) To prospectively assess whether specific germline polymorphisms related to
chemotherapy metabolism and resistance correlate with treatment-related
toxicity and overall survival. These assays include: UGT2B7 (epirubicin),
GST (cisplatin), ERCCI (cisplatin), XRCCI (cisplatin), TS (5-FU), DPD (5-
FU), and EGFR polymorphisms.
4) To prospectively assess whether serum levels of Insulin-Like Growth Fac-
tor-1 (IGF-1), IGF-2, and Insulin-Like Growth Factor Binding Protein 3
(IGFBP-3) correlate with overall survival.
5) To determine whether hospital procedure volume (at the center where surgi-
cal resection was performed) predicts recurrence-free and overall survival.
Study Chairs: C. Fuchs NCCTG Study
Chair: S. Alberts
Status: 12/15/2002 Activated Projected Number of Patients: 824
Schema: Registration/Randomize
Arm A 5-FU + LV
Arm B ECF + 5-FU
This is a CALGB coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study R-04 - September 2007
A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine
with Preoperative Radiation Therapy and Continuous Intravenous Infusion
(CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable
Carcinoma of the Rectum
Purpose of 1) The primary aim of this study is to compare the rate of local-regional relapse
Study: in patients receiving preoperative oral capecitabine given concurrently with
XRT to that in patients receiving preoperative CVI 5-FU given concurrently
with XRT. The study’s secondary aims include evaluating if the preopera-
tive administration of capecitabine given concurrently with XRT in the abil-
ity to downstage the primary tumor and increase the number of patients
undergoing sphincter-saving surgery.
Study Chairs: M. Roh, M.D. NCCTG Study H. C. Pitot, M.D.
P. Ganz, M.D. Chair:
C. Ko, M.D.
Status: 07/23/2004 Activated Projected Number of Patients: 1,606
Schema:
Group1
XRT with 5-FU
Surgery
Group 2
XRT with 5-FU + Oxaliplatin
Surgery
Group 3
XRT with Capecitabine
Surgery
Group 4
XRT with Capecitabine + Oxaliplatin
Surgery
This is a NSABP coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Other Closed GI Trials - September 2007
924652 * Phase II Trial: Evaluation of the Role of Multiple MetastasectomyCombined
with Systemic and Hepatic Artery Infusion Chemotherapy for Colorectal
Carcinoma Metastatic to the Liver
* Closed: 08/27/1999
* Final accrual data appeared in the 2000 NCCTG book
* Final toxicity data appeared in the 2000 NCCTG book
* Abstracts presented at the 2000 and 2001 ASCO meetings appeared in the
2000 and 2001 NCCTG books
* Manuscript status: Data maturing and the manuscript is in progress.
964152 * A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma
ofthe Stomach or Gastroesophageal Junction Incorporating Pretreatment
and Posttreatment Biopsies for Evaluation of Tumor Thymidylate Synthase,
MIB-1, Topoisomerase I, and p53
* Closed: 04/03/2002
* Final accrual tables appeared in the 2002 NCCTG book.
* Final toxicity tables appeared in the 2002 NCCTG book.
* Abstracts (2) appeared in the 1999 NCCTG book and were presented at
the 1999 ASCO meetings. An abstract was accepted for a poster
discussion session at the upcoming 2005 ASCO Annual Meetings.
* A manuscript is in progress.
MC9944 * Colorectal Cancer Screening: Fecal Blood vs. DNA
* Closed: 08/15/2005
* Final accrual and toxicity data appeared in the Spring 2006 NCCTG Book
* DDW abstract presented in 2005
* Manuscript status: In progress
N0044 * A Phase II Trial of Preoperative Radiation and Chemotherapy(Paclitaxel,
Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esoph-
ageal Cancer
* Closed: 01/07/2005
* The Final Accrual and Toxicity tables appeared in the Fall 2005 NCCTG
Book.
* Abstract: The ASCO abstract appeared in the Fall 2003 NCCTG Book.
* Manuscript on first 10 patients (interim toxicity analysis):
Published in the International Seminars in Surgical Oncology 2004,
I:9, November 8, 2004.
* Manuscript for entire study: Accepted by the American Journal of
Clinical Oncology.
N0144 * Profile of Long-Term Survivors on NCCTG Advanced Colorectal Cancer-
Treatment Trials
GI NCCTG GI Committee Other Closed Trials - Page 1 of 3
NCCTG Status Report for Other Closed GI Trials - September 2007
* Closed: 03/01/2002
* Abstract: The ASCO abstract appeared in the 2002 NCCTG book
* Manuscript: in preparation
N0242 * A Phase II Study of Docetaxel and Capecitabine in Patients withMeasurable
Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction
* Closed: 04/08/2005
* The Final Accrual, Baseline Characteristics, and Adverse Event Tables
appeared in the April 2006 NCCTG Book.
* Clinical Manuscript Status: Published in the Annals of Oncology,
April 2006: 17(4): 652-6.
* Translational Manuscript Status: Published in the Journal of
Supportive Oncology, January 2007: 5(1): 41-6.
N0442 * Determination of Clinical Significance of Caspase Inhibitory Proteins,Regu-
lators of Death Receptor (DR) -Mediated Apoptotic Pathway, and Correla-
tion of Apoptotic Proteins with Previously Studied Biomarkers in Stage II
and III Colorectal Carcinoma
* Closed: 07/26/2005
* Final accrual data appeared in the Spring 2005 NCCTG Meeting Book.
* An abstract was submitted and published for ASCO 2006 on EGFR
expression levels.
* A poster presentation on EGFR data was given at the 2007 GI Cancers
Symposium in Orlando, Florida.
* Additional ASCO 2007 abstracts were submitted as well (EGFR abstract,
BAX abstract).
* Other ongoing analyses continue and many manuscripts are forthcoming,
including an EGFR paper, and multiple tumor marker papers.
N9841 * A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus-
Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients
With Advanced Colorectal Carcinoma Previously Treated With 5-FU
* Closed: 12/17/2003
* Final accrual Spring 2004 book
* Final toxicity Spring 2004 book
* Manuscript status: An abstract was presented at the 2005 ASCO
meetings. The manuscript is in preparation.
N9942 * A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy inPa-
tients with Locally Advanced Pancreatic Cancer
* Closed: 08/08/2003
* The final patient characteristics table appeared in the 2002 NCCTG
book.
* The final adverse event table appeared in the Fall 2003 NCCTG book.
* A poster was presented at the 2003 ASCO meetings. The ASCO 2003
abstract appeared in the Fall 2003 NCCTG meeting book.
GI NCCTG GI Committee Other Closed Trials - Page 2 of 3
NCCTG Status Report for Other Closed GI Trials - September 2007
* Manuscript Status: Published in the Journal of Clinical Oncology,
June 2007: 25(18): 2567-72.
N9945 * A Phase II Trial Evaluating Multiple Metastasectomy Combined WithHe-
patic Artery Infusion of Floxuridine (FUDR) and Dexamethasone (DXM)
Alternating With Systemic Oxaliplatin (OXAL) and Capecitabine
(CAPCIT) for Colorectal Carcinoma Metastatic to the Liver
* Closed: 04/08/2005
* An abstract was presented as part of a Poster Discussion session at
ASCO 2006 (Atlanta, GA). The final manuscript is in progress and
anticipated to be submitted by then end of 2007.
GI NCCTG GI Committee Other Closed Trials - Page 3 of 3
Protocol Concepts for GI - September 2007
N0548 Randomized Phase II Trial of Cetuximab/Bevacizumab (CB) as Palliative-
First-Line Therapy in Patients with Advanced Colorectal CancerFollowed
by FOLFOX+CB vs. FOLFOX+B
Purpose of 1) Phase II trial to assess the efficacy of a dual biologics/dual antibody combi-
Study: nation regimen without conventional chemotherapy as first-line therapy in
patients with metastatic colorectal cancer based on a time-related endpoint.
2) Evaluate imaging studies (DCE-MRI, PET), plasma angiogenic activity, and
circulating tumor cells as predictive markers for efficacy of combined anti-
VEGF and anti-EGF-receptor therapy in colorectal cancer.
Schema: Randomization
First-Line: Cetuximab + bevacizumab
Second-line: FOLFOX7 + bevacizumab with or without cetuximab
*****************************************************************************
N054C Phase II Study of Sorafenib/Bevacizumab as Second-Line Therapy inPa-
tients with Metastatic Colorectal Cancer
Purpose of - Primary Goal
Study: 1) Evaluate proportion of patients who are progression-free at 3 months (in
comparison with results for single-agent bevacizumab in ECOG 3200).
- Secondary Goals
1) Evaluate response rate.
2) Evaluate overall survival.
3) Evaluate safety.
4) Evaluate feasibility.
Schema: Register
Bevacizumab
Sorafenib
*****************************************************************************
N064A Phase II Study of Panitumumab, Chemotherapy and External BeamRadia-
tion in Patients with Locally Advanced Pancreatic Cancer
Purpose of - Primary Goal
GI NCCTG GI Committee Protocol Concepts - Page 1 of 3
Protocol Concepts for GI - September 2007
Study: 1) Evaluate the 1-year survival rate in patients with locally advanced pancre-
atic cancer receiving panitumumab and continuous infusion 5-fluorouracil
administered concurrently with external beam radiation followed by gemcit-
abine and panitumumab.
- Secondary Goal
1) Secondary goals include overall survival, time to disease progression, con-
firmed response rate, duration of response, time-to-treatment failure, and
adverse events.
- Translational Studies
1) To evaluate several methods of defining pancreas cancers as EGFR positive.
2) Blood will be collected for assessment of circulating tumor cells and phar-
macogenomic analyses.
3) Tumor tissue will be collected to evaluate EGFR by IHC and FISH, and
other downstream markers of interest such as KRAS, EGFRvIII, and PTEN.
Schema: Registration
Panitumumab + Radiation + 5-Fluorouracil
Gemcitabine + Panitumumab
Panitumumab
*****************************************************************************
N064B Phase II Randomized Trial of Panitumumab, Erlotinib, and Gemcitab-
inevs. Erlotinib and Gemcitabine in Patients with Untreated, Metastatic-
Pancreatic Adenocarcinoma
Purpose of - Primary Goal
Study: 1) To assess whether the addition of dual-epidermal growth factor receptor
(EGFR) inhibition to standard gemcitabine and erlotinib chemotherapy
results in an improvement in overall survival in untreated, metastatic pancre-
atic adenocarcinoma patients.
- Secondary Goals
1) To compare objective response rates, progression-free survival, time-to-
treatment failure, and adverse event rates between the 2 treatment arms.
- Translational
1) To evaluate several methods of defining pancreas cancers as EGFR positive.
2) Tumor tissue will be collected to evaluate EGFR by IHC and FISH, and
other downstream markers of interest such as KRAS, EGFRvIII, PTEN.
3) Blood will be collected for assessment of circulating tumor cells and phar-
macogenomic analyses.
Schema: Randomize
Gemcitabine + Erlotinib
Gemcitabine + Erlotinib + Panitumumab
GI NCCTG GI Committee Protocol Concepts - Page 2 of 3
Protocol Concepts for GI - September 2007
*****************************************************************************
N0743 Validation of GHI (Genomic Health) Algorithm for Estimation of theRisk
of Recurrence at 5 Years in Patients with Stage III Colon CancerRandom-
ized to Receive 5FU/LV on NCCTG Protocols 894651 and 914653
Purpose of 1) Validate the GHI algorithm in patients with Stage III colon cancer treated
Study: with 5FU/LV on the control arms of NCCTG trials 894651 and 914653.
2) Initiate a program to collect additional tissue blocks for patients with Stage
III colon cancer entered into prior NCCTG trials that included a surgery
only control arm, in cluding NCCTG 784852, 844652 (INT 0035), and
874651.
Schema: No Schema Defined
GI NCCTG GI Committee Protocol Concepts - Page 3 of 3
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Breast Program
Scientific Coordinator: Edith A Perez, MD
Community Co-Chair: Kendrith M Rowland Jr, MD
Lead Nurse: Frances M Palmieri, RN, OCN, MSN
Lead Statistician: Amylou C Dueck, PhD
Studies Open for Patient Enrollment
Fall 2007
I. Surgery
II. Radiation
A. NSABP B-39 / RTOG 0413: To evaluate standard vs partial breast RT. Active through
the CTSU. Coordinating centers are NSABP/RTOG.
III. Adjuvant Therapy
A. Monoclonal Antibody
1. RC0639: Phase II study of cardiac safety and tolerability of an adjuvant
chemotherapy plus trastuzumab with lapatinib in patients with resected HER2+ breast
cancer. Extensive quality of life and translational components: cardiac markers,
circulating tumor cells, metabolomics. Open to MCCRC only.
B. Bisphosphonates and Hormonal Therapy
1. IBCSG 24-02 (SOFT): Phase III trial of tamoxifen alone vs. ovarian ablation +
tamoxifen vs. ovarian ablation + exemestane in premenopausal women with ER+
and/or PR+ breast cancer who remain premenopausal following adjuvant
chemotherapy or had no adjuvant chemotherapy. Active through the CTSU.
2. IBCSG 25-02 (TEXT): Phase III trial of triptorelin + tamoxifen vs. triptorelin +
exemestane in premenopausal women with ER+ and/or PR+ breast cancer who
remain pre-menopausal after chemotherapy or had no adjuvant chemotherapy. Active
through the CTSU.
3. MA.17R: A Double Blind Randomization to Letrozole or Placebo for Women
Previously Diagnosed with Primary Breast Cancer Completing Five Years of
Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen
(Including Those in the MA.17 Study). Enrollment has now opened to any woman
who has completed 5 years of letrozole, anastrozole or exemestane. Enrollment
through NCCTG.
4. MA.27: Phase III trial of exemestane versus anastrozole in postmenopausal women
with hormone receptor positive primary breast cancer. Active through the CTSU.
5. MA.27B: Companion study to investigate the influence of five years of adjuvant
anastrozole or exemestane on bone mineral density in postmenopausal women with
primary breast cancer. This is a companion study to NCIC MA.27. Active through
the CTSU.
6. N0434 (MA.27D): Companion study to investigate the association of breast density
changes, plasma hormone changes, and breast cancer recurrence. This is a
companion study to NCIC MA.27. Active through the CTSU.
7. SWOG S0307: Phase III trial of adjuvant clodronate, ibandronate, or zoledronic
acid. Active through the CTSU.
8. PACCT-1 (TAILORx): Phase III trial incorporating Oncotype DX™ technology for
adjuvant therapy decision-making. Extensive translational component: gene
expression profiling. Active through the CTSU.
C. Chemotherapy
1. CALGB 40101: Phase III trial of AC (4 vs 6 cycles) vs. paclitaxel (4 vs 6 cycles) in
women with operable breast cancer and 0-3 positive axillary lymph nodes. Active
through the CTSU.
2. NSABP B-36: Phase III study comparing AC to FEC in patients with node-negative
resected breast cancer. Active through the CTSU.
3. SWOG S0221: Phase III trial of 2 schedules of AC followed by paclitaxel (+ G-
CSF) q2w vs. weekly paclitaxel. Also known as “dose dense vs. denser”
chemotherapy. Active through the CTSU.
IV. Stage III
V. Stage IV
1. N0337: Phase II Study of Capecitabine in Combination with Vinorelbine and
Trastuzumab as 1st or 2nd line treatment of HER2+ MBC. Must be previously treated
with taxanes.
2. N0537: Phase II Trial of VEGF Trap in Patients with Metastatic Breast Cancer
Previously Treated with Anthracycline and/or Taxane. First or 2nd-line treatment for
MBC. Prior A or T required. Translational component: tissue markers, angiogenesis
markers in plasma.
3. N0539: Phase II Trial of Fulvestrant and Bevacizumab in Patients with Metastatic
Breast Cancer Previously Treated with an Aromatase Inhibitor. Quality of life and
translational studies (tissue and blood). Non-measurable only disease allowed.
Proposed Studies at Different Stages of Review
1. N0632: Phase II Trial of Vinflunine and Capecitabine in Previously Treated Metastatic
Breast Cancer. Quality of life and translational components: tissue markers
(centromere analysis), circulating tumor cells. Expected activation in September
2007. Enrollment will be available through NCCTG.
2. N063D / BIG 2-06 ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment
Optimisation Study - A randomised, multi-centre, open-label, phase III study of
adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with
HER2/ErbB2 positive primary breast cancer. Adjuvant or neoadjuvant following
completion of anthracycline-based chemotherapy. Extensive quality of life and
translational components: frozen tissue, genomics, proteomics. Will be available
through the CTSU.
3. N063H / CALGB 40502: Randomized phase III trial comparing the combination of
weekly ixabepilone versus weekly paclitaxel versus weekly nab-paclitaxel (with
bevacizumab) in patients with previously untreated MBC. Will be available through
the CTSU.
4. N063I: Changes in breast density and plasma hormone levels after one year of AI
therapy. For patients going on exemestane or anastrozole as part of their clinical care.
This epidemiological study is similar to N0434 (MA.27D) and designed to
supplement the results of that study. Expected activation in September 2007.
Enrollment will be available through NCCTG.
5. N0733: Randomized phase II trial of capecitabine and lapatinib with or without
IMC-A12 in patients with HER2 positive, trastuzumab-resistant breast cancer
previously treated with an anthracycline and/or a taxane. Translational components:
tissue markers, circulating tumor cells, serum markers.
6. N0735: Phase II trial of nab (nanoparticle albumin bound)-paclitaxel (nab-paclitaxel;
Abraxane) in combination with gemcitabine and bevacizumab in patients with
metastatic breast cancer. Translational components: tissue markers, circulating
tumor cells, serum markers.
7. N0737: Phase II study of lapatinib and bevacizumab in patients with HER2 positive
breast cancer with brain metastases. Translational components: DCE MRI substudy,
DNA SNP analyses, circulating tumor cells, circulating endothelial cells, serum &
plasma markers, tissue banking.
8. RC0731: Randomized phase II study of sorafenib versus placebo in combination
with an AI for patients with metastatic breast cancer. Translational components:
circulating tumor cells, circulating endothelial cells. Non-measurable only disease
allowed. Will be open to MCCRC only.
9. Concept: Phase III trial of trastuzumab as adjuvant therapy for patients with node
positive resected HER2 normal breast cancer (IHC 0-2 and/or FISH ratio P); DDAC Followed by
DD Paclitaxel Plus Gemcitabine (DD AC->PG)
B-39 NSABP B-39, "A Randomized Phase III Study of Conventional Whole
BreastIrradiation (WBI) Versus Partial Breast Irradiation (PBI) for
Womenwith Stage 0, I or II Breast Cancer"
E2100 E2100, A Randomized Phase III Trial of Paclitaxel versus Paclitaxelplus
Bevacizumab (rhuMAb VEGF) as First-Line Therapy for LocallyRecur-
rent or Metastatic Breast Cancer
MA.20 A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
MA.21 A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin
AlfaFollowed by Paclitaxel Versus Sequenced AC Followed by Paclitax-
elVersus CEF as Therapy for Premenopausal Women and EArly Post-
menopausalWomen Who Have Had Potentially Curative Surgery for
Node Positive orHigh Risk Node Negative
MA.27 A Randomized Phase III Trial of Exemestane Versus Anastrozole
inPostmenopausal Women with Receptor Positive Primary Breast Can-
cer
S0221 Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Sched-
uleAC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly
for 12Weeks as Post-Operative Adjuvant Therapy in Node-Positive or
High-RiskNode Negative Breast Cancer
BREAST NCCTG BREAST Committee Table of Contents - Page 4 of 4
NCCTG Status Report for Study E1199 - September 2007
Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by
Paclitaxel or Docetaxel Given Weekly or Every Three Weeks in Patients With
Axillary Node Positive or High Risk Node-Negative Breast Cancer
Purpose of 1) To determine whether docetaxel improves disease-free survival and overall
Study: survival when compared to paclitaxel following 4 cycles of doxorubicin-
cyclosphosphamide therapy.
2) To determine whether weekly administration of taxanes x 12 weeks
improves disease-free survival and overall survival compared to the conven-
tional schedule of every 3 weeks x 4 cycles.
3) To compare toxicity of docetaxel in the differing administration schedules.
4) To compare the toxicity of paclitaxel in the differing administration sched-
ules.
5) To compare the toxicities of paclitaxel vs docetaxel on the every 3 weeks x 4
cycles regimens.
6) To compare the toxicities of paclitaxel vs docetaxel on the weekly x 12
weeks schedule.
Study Chairs: Edith A. Perez M.D. QC Specialist: Kathleen A. Merkle CCRP
Loren K. Tschetter M.D.
Statistician: Nurse Resource:
Status: 10/15/1999 Activated Projected Number of Patients: 4760
01/08/2002 Perm. Closed
Excluded: None Final Accrual: 486
Stratification ER status Nodal status
Factors: Tumor size Type of Surgery
Schema: Randomize
A) ADR + CTX every 3 wks x 4 cycles
Paclitaxel every 3 wks x 4 cycles
B) ADR + CTX every 3 wks x 4 cycles
Paclitaxel wkly x 12
C) ADR + CTX every 3 wks x 4 cycles
Docetaxel every 3 wks x 4 cycles
D) ADR + CTX every 3 wks x 4 cycles
Docetaxel wkly x 12 wks
Treating Schedule:
Arm Agent Dose Route Days Freq
A ADR 60 mg/m2 IV 1 Every 3 wks; wks 1-12
A CTX 600 mg/m2 IV 1 Every 3 wks; wks 1-12
BREAST NCCTG BREAST Committee E1199 - Page 1 of 2
NCCTG Status Report for Study E1199 - September 2007
Arm Agent Dose Route Days Freq
A Paclitaxel 175 mg/m2 IV infusion over 3 hrs 1 Every 3 wks x 4; wks 13-24
B ADR 60 mg/m2 IV 1 Every 3 wks; wks 1-12
B CTX 600 mg/m2 IV 1 Every 3 wks; wks 1-12
B Paclitaxel 80 mg/m2 IV infusion over 1 hr 1 Wkly; wks 13-24
C ADR 60 mg/m2 IV 1 Every 3 wks; wks 1-12
C CTX 600 mg/m2 IV 1 Every 3 wks; wks 1-12
C Docetaxel 100 mg/m2 IV infusion over 1 hr 1 Every 3 wks X 4; wks 13-24
D ADR 60 mg/m2 IV 1 Every 3 wks; wks 1-12
D CTX 600 mg/m2 IV 1 Every 3 wks; wks 1-12
D Docetaxel 35 mg/m2 IV infusion over 1 hr 1 Wkly; wks 13-24
Accrual: Enrollment to this intergroup study was terminated on January 8, 2002, having met its
accrual goal of 5,052 patients. NCCTG accrued 486 patients.
Additional Information: The final study summary appeared in the Spring 2007 Meeting Book.
Results were also reported in an ASCO 2007 abstract:
Sparano JA, Wang M, Martino S, Jones V, Perez A, Saphner TJ, Wolff AC, Sledge GW, Wood
WC, Davidson NE. Phase III study of doxorubicin-cyclophosphamide followed by paclitaxel or
docetaxel given every 3 weeks or weekly in patients with axillary node-positive or high-risk
node-negative breast cancer: results of North American Breast Cancer intergroup trial E1199.
ASCO 2007, Abstract 516.
BREAST NCCTG BREAST Committee E1199 - Page 2 of 2
NCCTG Status Report for Study E2103 - September 2007
A Phase II Trial of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) and
Carboplatin in Patients with HER2/neu-Positive Metastatic Breast Cancer
Purpose of - Primary Objective
Study: 1) To determine the response rate to combination therapy with weekly BMS-
247550 with trastuzumab and carboplatin in patients with metastatic breast
cancer known to overexpress or amplify HER2.
- Secondary Objectives
1) To determine time to disease progression (TTP) and time to treatment fail-
ure (TTF), toxicity, and overall survival after treatment with BMS-247550,
trastuzumab, carboplatin in patients with metastatic breast cancer known to
overexpress or amplify HER2.
2) To correlate levels of phospho-STAT3 with levels of HER2, Survivin, and
EGFR expression as measured in tissue by immunohistochemistry.
Study Chairs: Edith A. Perez M.D. QC Specialist:
Philip J. Stella M.D.
Statistician: Nurse Resource:
Status: 08/13/2004 Activated Projected Number of Patients: 60
03/24/2006 Perm. Closed
Excluded: None Final Accrual: 2
Stratification
Factors:
Schema: Registration
Trastuzumab + BMS-247550 + Carboplatin
Treating Schedule:
Arm Agent Dose Route Days Freq
- Trastuzumab 4 mg/kg IV infusion over 90 min- 1 Day 1 only (loading dose)
utes
- Trastuzumab (sub- 2 mg/kg IV infusion over 30 min- weekly 23 consecutive weekly doses
sequent doses) utes
- BMS-247550 15 mg/m2 IV infusion over 1 hour 1, 8, and 15 Q 4 weeks for maximum of 6
cycles
- Carboplatin AUC dose of 2 IV over 1 hour 1, 8, and 15 Q 4 weeks for maximum of 6
cycles
BREAST NCCTG BREAST Committee E2103 - Page 1 of 2
NCCTG Status Report for Study E2103 - September 2007
Study Design: This phase II clinical trial was designed to test the null hypothesis that the true
response rate for BMS-247550/trastuzumab/carboplatin in women with HER2 positive breast
cancer is at most 57% against the alternative that the true response rate of this combination in
this patient population is at least 75%.
A toxicity stopping rule was included in the trial design. Toxicity data from the first 10 patients
on trial were to be analyzed after these patients had received 2 cycles of treatment. If a grade 3/4
febrile neutropenia was reported by 4 or more of these 10 patients or a grade 3/4 neuropathy was
reported by 4 or more of these 10 patients, accrual would be suspended and trial modifications
would be considered to reduce toxicity. If such modifications were not possible the trial would
be closed to further accrual.
Accrual: NCCTG accrued 2 patients to this trial. This study was closed to accrual effective
March 24, 2006, having met its accrual goal. Analysis is ongoing.
BREAST NCCTG BREAST Committee E2103 - Page 2 of 2
NCCTG Status Report for Study E2104 - September 2007
Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxo-
rubicin and Cyclophosphamide Followed by Paclitaxel in Patients with Lymph
Node Positive Breast Cancer
Purpose of - Primary Objective
Study: 1) To determine the incidence of clinically apparent cardiac dysfunction in
patients with lymph node positive breast cancer treated with bevacizumab
and dose dense doxorubicin/cyclophosphamide followed by paclitaxel
(ddAC>T).
- Secondary Objectives
1) To evaluate changes in LVEF during treatment.
2) To evaluate non-cardiac toxicity.
Study Chairs: Edith A. Perez M.D. QC Specialist:
Tom R. Fitch M.D.
Statistician: Nurse Resource:
Status: 02/24/2006 Activated Projected Number of Patients: 20
11/06/2006 Perm. Closed
Excluded: None Final Accrual: 5
Stratification None
Factors:
Schema: Register
Arm A: Doxorubicin/Cyclophosphamide/Bevacizumab followed by
Paclitaxel/Bevacizumab followed by Bevacizumab
Arm B: Doxorubicin/Cyclophosphamide followed by
Paclitaxel/Bevacizumab followed by Bevacizumab
Treating Schedule:
Arm Agent Dose Route Days Freq
+ Doxorubicin 60 mg/m2 IV push 1 Every 14 days (cycles 1-4)
+ Cyclophospha- 600 mg/m2 IV infusion 1 Every 14 days (cycle 5-8)
mide
A Bevacizumab 10 mg/kg * IV infusion 1 Every 14 days (cycles 1-18)
A Paclitaxel 175 mg/m2 IV infusion 1 Every 14 days (cycles 5-18)
B Paclitaxel 175 mg/m2 IV infusion 1 Every 14 days (cycles 5-22)
* Bevacizumab given after AC Arm A only
+ Arms A and B
BREAST NCCTG BREAST Committee E2104 - Page 1 of 2
NCCTG Status Report for Study E2104 - September 2007
Accrual: NCCTG accrued 5 patients on this study. Accrual to Arm A was closed in July 2006
having met its accrual goal. Accrual to Arm B was closed in November 2006 having met its
accrual goal. Analysis is ongoing.
BREAST NCCTG BREAST Committee E2104 - Page 2 of 2
NCCTG Status Report for Study E5194 - September 2007
Local Excision Alone for Selected Patients with DCIS of the Breast
Purpose of 1) To evaluate 5 and 10 year local recurrence rate (in situ or invasive) after
Study: local excision for patients with favorable prognosis DCIS.
2) To evaluate concordance between institutional and central review patholo-
gists with respect to diagnosis and grading of DCIS.
3) To identify parameters that show increased or decreased risk of recurrence
in the absence of RT.
4) To evaluate patterns of salvage of recurrences in the breast and correlate
with rate of breast conservation.
5) To evaluate 5 and 10 year relapse-free, overall, and cause-specific survival.
Study Chairs: John H. Donohue M.D. QC Specialist: Kathleen A. Merkle CCRP
Gist H. Farr Jr. M.D.
Kendall Reed M.D.
William Charles Sternfeld M.D.
Statistician: Nurse Resource:
Status: 11/12/1997 Activated Projected Number of Patients: 1176
10/22/2002 Perm. Closed
Excluded: None Final Accrual: 136
Stratification Grade: low/intermediate versus high
Factors: Adj Trt Planned: yes versus no
Schema: Register
Central Pathology Review
Observation: Standard Clinical + Mammographic Follow-up
Accrual: This study was closed to accrual for patients with low or intermediate grade DCIS as
well as for patients with high grade DCIS on October 22, 2002. The accrual goal for patients
with low or intermediate grade DCIS was met. A slow rate of accrual led to the premature clo-
sure of accrual of patients with high grade DCIS. NCCTG accrued 136 of the 711 patients
enrolled onto this study.
Study Status: The final study summary appeared in the Spring 2007 Meeting Book.
Additional Information: An abstract reporting the 5-year results was presented as the San
Antonio Breast Cancer Symposium 2006: Hughes L, Wang M, Page D, Gray R, Solin L, David-
son N, Lowen M, Ingle J, Wood W. Five year results of intergroup study E5194: local excision
alone (without radiation treatment) for selected patients with ductal carcinoma in situ (DCIS).
SABCS 2006, Abstract 29.
BREAST NCCTG BREAST Committee E5194 - Page 1 of 1
NCCTG Status Report for Study N0332 - September 2007
Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic
Breast Cancer
Purpose of - Primary:
Study: 1) To assess the anti-tumor activity of a dose dense regimen of docetaxel and
irinotecan for patients with refractory breast cancer.
- Secondary:
1) To assess the toxicity profile of the weekly dose dense combination of doce-
taxel and irinotecan.
2) To obtain an estimate of the progression free survival (PFS) distribution.
3) To obtain an estimate of the overall survival (OS) distribution.
Study Chairs: Edith A. Perez M.D. QC Specialist: Tracy L. Rieken
Muhammad Salim M.D.
Statistician: David W. Hillman M.S. Nurse Resource: Frances M. Palmieri R.N.,
M.S.N.
Status: 04/09/2004 Activated Projected Number of Patients: 69
11/03/2006 Perm. Closed
Excluded: 5 Final Accrual: 70
Stratification None
Schema: Register
A) Irinotecan + Docetaxel
Treating Schedule:
Arm Agent Dose Route Days Freq
A Docetaxel* 25 mg/m2 In 250 ml D5W or NS IV 1 and 8 Every 21 days
infusion over 1 hr**
A Irinotecan 70 mg/m2 In 500 ml D5W or NS IV 1 and 8 Every 21 days
infusion over 60 minutes
* Dexamethasone 8 mg orally is administered 12 hours prior to
docetaxel, 10 mg intravenous just before infusion, and 8 mg orally 12
hours after chemotherapy.
**If by NS IV infusion: over 1 hour in a non-pvc container and through
a polyethylene-lined set.
BREAST NCCTG BREAST Committee N0332 - Page 1 of 3
NCCTG Status Report for Study N0332 - September 2007
Study Design: A single stage phase II clinical trial with an interm analysis is being conducted
in women with refractory metastatic breast cancer to assess the anti-tumor and toxicity profile of
irinotecan and docetaxel. The study was designed to test whether the response rate is at most
20% against the alternative that the response rate is at least 35%.
Accrual: This study was opened to accrual to the NCCTG on April 9, 2004. Seventy patients
enrolled onto this study as of the closing date of November 3, 2006. Three patients have been
deemed ineligible, one a major violation, and two never received study treatment and have been
deemed cancellations.
Patient Characteristics: The median age (range) of the patient cohort is 60 (29-81) years.
Fifty-nine percent are ER+ and forty-three percent are PR+.
Adverse Events: Adverse event data are available on 64 patients. Eleven patients experienced
grade 4 adverse events. The most common grade 4 events were neutropenia(9%), leukope-
nia(5%), and dyspnea(5%). The most frequent non-hematologic grade 3 adverse events reported
were fatigue(23%), diarrhea-no colostom(13%) and nausea(11%). See Adverse Events Table
for more details.
Study Status: The study was permanently closed to accrual on November 3, 2006. An abstract
summarizing the results of this study has been submitted and accepted for the 2007 San Antonio
Breast Conference Symposium.
BREAST NCCTG BREAST Committee N0332 - Page 2 of 3
NCCTG Status Report for Study N0332 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 64
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 26 41 7 11 6 9 0 0
LEUKOPENIA A 35 55 8 13 3 5 0 0
ANEMIA A 48 75 2 3 0 0 0 0
THROMBOCYTOPENIA A 10 16 1 2 0 0 0 0
Constitutional Symptoms FATIGUE A 45 70 15 23 0 0 0 0
Dermatology/Skin ALOPECIA A 16 25 0 0 0 0 0 0
NAIL CHANGES A 15 23 0 0 0 0 0 0
RASH A 11 17 0 0 0 0 0 0
Gastrointestinal ANOREXIA A 30 47 4 6 0 0 0 0
NAUSEA A 38 59 7 11 0 0 0 0
STOMATITIS A 21 33 0 0 0 0 0 0
VOMITING A 21 33 3 5 0 0 0 0
DIARRHEA-NO COLOSTOM A 43 67 8 13 1 2 0 0
Hepatic SGOT (AST) A 22 34 2 3 1 2 0 0
SGPT (ALT) A 17 27 0 0 0 0 0 0
BILIRUBIN A 1 2 1 2 1 2 0 0
Infection/Febrile Neutropenia FEBRILE NEUTROPENIA A 0 0 1 2 1 2 0 0
Musculoskeletal FRACTURE A 0 0 0 0 1 2 0 0
Neurology NEURO-SENSORY A 32 50 0 0 0 0 0 0
NEURO-MOTOR A 11 17 1 2 0 0 0 0
Pain MYALGIA A 24 38 2 3 0 0 0 0
ARTHRALGIA A 21 33 2 3 1 2 0 0
PAIN-BONE A 1 2 0 0 1 2 0 0
Pulmonary DYSPNEA A 24 38 3 5 3 5 0 0
Death DISEASE PROGRESSION A 0 0 0 0 0 0 1 2
Maximum Grade Adverse Event A 23 36 28 44 11 17 1 2
BREAST NCCTG BREAST Committee N0332 - Page 3 of 3
NCCTG Status Report for Study N0337 - September 2007
Phase II Study of Capecitabine in Combination with Vinorelbine and Trastu-
zumab for the First- or Second-Line Treatment of HER2+ Metastatic Breast
Cancer
Purpose of - Treatment
Study: 1) Primary - To evaluate the overall response rate.
2) Secondary - To determine the time to progression, duration of response and
overall survival and to evaluate the safety profile of the combination of
capecitabine, vinorelbine and trastuzumab with the selected schedule using
the NCI CTCAE (Version 3.0).
- Translational Research
1) Submission of biopsy tissue and blood samples is not mandatory, but is
strongly encouraged. Biopsy tissue and blood samples will be stored for
planned future research evaluating proteins and genes that may correlate
with drug toxicity or efficacy (genetic studies of inheritable conditions will
not be part of the research).
2) We also propose to evaluate molecular markers in circulating tumor cells, to
investigate their correlation with clinical response.
Study Chairs: Winston W. Tan M.D. QC Specialist: Tracy L. Rieken
Muhammad Salim M.D.
Statistician: Jake B. Allred M.S. Nurse Resource: Frances M. Palmieri R.N.,
M.S.N.
Status: 01/28/2005 Activated Projected Number of Patients: 42
Excluded: None Final Accrual: NA
Stratification None
Factors:
Schema: Register
Capecitabine + Vinorelbine + Trastuzumab
Treating Schedule:
Arm Agent Dose Route Days Freq
Capecitabine 825 mg/m2 twice PO 1-14 First dose Q 3 weeks
scheduled defined daily (total daily Day 1(AM) and
dose of 1650 mg/ last dose Day 14
m2) (PM)
Vinorelbine 25 mg/m2 IV 1 and 8 Q 3 weeks
Trastuzumab 8 mg/kg (loading IV Day 1, Cycle 1,
dose initial dose only
BREAST NCCTG BREAST Committee N0337 - Page 1 of 3
NCCTG Status Report for Study N0337 - September 2007
Arm Agent Dose Route Days Freq
Trastuzumab 6 mg/kg IV Day 1, Cycle 2 and Q 3 weeks
all subsequent
doses
Study Design: This study is using a single stage phase II design to ascertain response rate of the
3 drug regimen as a first or second line treatment for patients with HER2+ metastatic breast can-
cer. The design was chosen to test whether the response rate is at most 45% versus the alterna-
tive that the response rate is at least 65%.
Accrual: This study has an accrual of 35 patients thus far. Five patients have been accrued in
the last 6 months.
Adverse Events: Adverse event information is available on 31 of the patients enrolled on study.
Twenty-three of these patients have had a severe adverse event that was deemed at least possibly
related to treatment. The most common severe adverse event was neutropenia (11 grade 3 and 7
grade 4) all deemed at least possibly related to treatment. See the Adverse Events table for more
details.
Study Status: This study remains open to accrual. As of June 19, 2006 the stopping rule was
updated to encompass all patients on the trial. If at any time after the first 5 patients at least 40%
of all patients have experienced a non-hematological severe adverse event (except alopeica or
tast alterations), which is at least possibly related to treatment and is not resolved to Paclitaxel
B: AC --> Paclitaxel --> Trastuzumab
C: AC --> Paclitaxel + Trastuzumab --> Trastuzumab
Treating Schedule:
Arm Agent Dose Route Days Freq
A ADR 60 mg/m2 IV push thru running IV Day 1 wks 1, 4, 7, Every 3 wks X 4
of NS 10
A CTX 600 mg/m2 IV infusion 250 ml NS Day 1 wks 1, 4, 7, Every 3 wks X 4
over 20-30 min 10
A Taxol 80 mg/m2 IV in 250 ml D5W or NS Day 1 (starting wk Wkly X 12
over 1 hr 13)
B ADR 60 mg/m2 IV push thru running IV Day 1 wks 1, 4, 7, Every 3 wks X 4
of NS 10
B CTX 600 mg/m2 IV infusion 250 ml NS Day 1 wks 1, 4, 7, Every 3 wks X 4
over 20-30 min 10
B Taxol 80 mg/m2 IV infusion 250 ml D5W Day 1 (starting wk Wkly X 12
or NS over 1 hr 13)
B HERCEP First dose - 4 mg/ IV over 90 min Day 1 (starting wk First dose only
kg 25)
B HERCEP Subsequent doses - IV over 30 min Day 1 (starting wk Wkly X 51 (total Rx time for
2 mg/kg 26) HERCEP - 52 wks)
BREAST NCCTG BREAST Committee N9831 - Page 1 of 4
NCCTG Status Report for Study N9831 - September 2007
Arm Agent Dose Route Days Freq
C ADR 60 mg/m2 IV push thru running IV Day 1 wks 1, 4, 7, Every 3 wks X 4
of NS 10
C CTX 600 mg/m2 IV in 250 ml NS over 20- Day 1 wks 1, 4, 7, Every 3 wks X 4
30 min 10
C Taxol 80 mg/m2 IV in 250 ml D5W or NS Day 1 (starting wk Wkly x 12
over 60 min 13)
C HERCEP (admin First dose - 4 mg/ IV over 90 min Day 1 (starting wk First dose
with Taxol) kg 13)
C HERCEP (admin Subsequent doses - IV over 30 min Day 1 (starting wk Wkly X 11 (total Rx time HER-
after Taxol) 2 mg/kg 14) CEP is 12 weeks)
C HERCEP (admin 2 mg/kg IV over 30 min Day 1 (starting wk Wkly x 40
after HERCEP/ 25)
Taxol)
Following the release of the results of the joint efficacy analyis in
April of 2004, patients who were randomized to Arm A who had not
completed paclitaxel could choose to receive trastuzumab concurrently
with paclitaxel then trastuzumab alone or at the completion of
paclitaxel for a total of 52 weeks of trastuzumab, patients who were
randomized to Arm A who had completed paclitaxel no more than 6 months
previously could choose to recieve 52 weeks of trastuzumab alone, and
patients randomized to Arm B who had not completed paclitaxel could
choose to receive trastuzumab concurrently with remaining paclitaxel
doses and then trastuzumab alone for a total for 52 weeks of
trastuzumab.
Accrual: There has been 3505 patients accrued onto this trial - NCCTG (14%), SWOG (27%),
CALGB (27%) and ECOG (32%).
There have been 62 patients who have been declared ineligible. The reasons include: dermal
lymphatic invasion (10), not T1-T3 disease (9), disease remaining in the surgical margin (9),
began AC prior to registration (3), nodes were not positive by H&E(2), failure to examine at
least 6 nodes on ALND (8), failure to meet the definition of high node negative disease (2), lag
between surgery and registration too great (1), failure to receive radiation when 4-10 lymph
nodes are positive (2), local laboratory finding that tumor was not Her2 positive (7), refused to
have a pregnancy test (2), failure to complete MUGA/ECHO prior to registration (2), pre-regis-
tration LVEF level below LLN (3), and active treatment with calcium channel blockers for
supraventricular tachycardia (1).
There were 28 women who withdrew consent prior to receiving treatment.
There were 283 who were not found to be HER-2 positive on central path testing.
BREAST NCCTG BREAST Committee N9831 - Page 2 of 4
NCCTG Status Report for Study N9831 - September 2007
Adverse Events: AC Phase: Toxicity data are available for 3114 women during AC phase. The
most common severe toxicities reported during this phase of the trial were: grade 4/5 neutrope-
nia (28%), grade 4/5 leukopenia (8%), grade 3/4/5 febrile neutropenia (5%), and grade 3 nausea
(5%).
Paclitaxel +/- Trastuzumab Phase: Toxicity data are available for 1442 women on Arm A & B
during Paclitaxel who were registered on study prior to 4/24/2004. The most common moderate
to severe toxicities reported during this phase of the trial were: grade 2 neuro-sensory (14%),
grade 3 neuro-sensory (5%), grade 2+ myalgia (9%), grade 2+ arthralgia (9%), grade 2 nail
changes (6%), grade 2 neuro-motor (4%), and grade 3 neuro-motor (1%). Toxicity data are
available for 908 women on Arm C during P+T phase. The most common moderate/severe tox-
icities were: grade 2 neuro-sensory (11%), grade 3 neurosensory (3%), 2/3 myalgia (8%), grade
2/3 arthralgia (7%), grade 2 neuro-motor(2%), grade 3 neuro-motor(1%), and grade 2 nail
changes (6%).
Trastuzumab Phase: Toxicity data are available for 662 women registered on Arm B before 4/
24/2004 during the trastuzumab alone phase. The most common moderate/severe toxicities
were: grade 2 neuro-sensory (7%), grade 3 neuro-sensory (2%), grade 2/3 myalgia (5%), grade
2/3 arthralgia (6%), and grade 2 nail changes (3%). Toxicity data are available for 789 patients
on the Arm C during the trastuzumab alone phase. The most common moderate/severe toxici-
ties reported were: grade 2 neuro-sensory (7%), grade 3 neuro-sensory (2%), grade 2/3 arthral-
gia (7%), grade 2/3 myalgia (4%), and grade 2 nail changes (4%).
Among the women enrolled prior to 4/24/2004, there have been 40 confirmed cases of conges-
tive heart failure - 2 on Arm A, 18 on Arm B and 20 on Arm C.
Study Status: Patients should continue to be followed per protocol.
A manuscript describing cardiac tolerability is under review. Its abstract is presented below:
Purpose: To assess cardiac safety and potential cardiac risk factors associated with trastuzumab
in the NCCTG N9831 Intergroup adjuvant breast cancertrial.
Patients and Methods:Patients with HER2-positive operable early breast cancer were random-
ized to 1 of 3 treatment arms: doxorubicin plus cyclophosphamide (AC) followed by either
weekly paclitaxel (Arm A); or paclitaxel then trastuzumab (Arm B); or paclitaxel plus trastu-
zumab then trastuzumab alone (Arm C). Left ventricular ejection fraction (LVEF) was evaluated
at registration and 3, 6, 9, and 18-21 months post-registration.
BREAST NCCTG BREAST Committee N9831 - Page 3 of 4
NCCTG Status Report for Study N9831 - September 2007
Results:5.0% of 2992 patients who completed AC treatment had post-AC LVEF decreases disal-
lowing the administration of any trastuzumab treatment. A total of 1944 patients completed AC
with a satisfactory or no LVEF evaluation and proceeded to post-AC therapy. Post-AC cardiac
events congestive heart failure [CHF] or cardiac death [CD]) were: Arm A, n=3 (2 CHF, 1 CD);
Arm B, n=19 (18 CHF, 1 CD); Arm C, n=19 (all CHF); 3-year cumulative incidence was 0.3%,
2.8%, and 3.3%, respectively. Cardiac function improved in most CHF cases following trastu-
zumab discontinuation and cardiac medication. Factors associated with increased risk of a car-
diac event after AC in Arms B and C were older age (P T + TAM
Group 2 - AT + TAM
Group 3 - ATC + TAM
This is an NSABP coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study B-33 - September 2007
A Randomized, Placebo-controlled, Double-blind Trial Evaluating the Effect
of Exemestane in Clinical Stage cT1-3N0-1M0 Postmenopausal Breast Cancer
Patients Completing at Least Five Years of Tamoxifen Therapy
Purpose of 1) The primary aim of this study is to determine whether the oral administra-
Study: tion of exemestane for 5 years in post menopausal women with ER+ and/or
PR+ breast cancer (T1-3 N0-1 M0) who have completed 5 years of TAM
will prolong DFS compared to placebo.
2) To evaluate the effect of TAM withdrawal on bone and to determine if exe-
mestane has any additional effects on the rate of bone loss after TAM with-
drawal.
3) To evaluate the effect of exemestane on blood lipds.
Study Chairs: James N. Ingle, M.D. NCCTG Study
Chair:
Status: 05/01/2001 Activated Projected Number of Patients: 3000
10/09/2003 Perm. Closed
Schema: Randomize
Arm A: Exemestane x 5 years
Arm B: Placebo x 5 years
This is an NSABP coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study B-34 - September 2007
A Clinical Trial Comparing Adjuvant Clodronate Therapy vs. Placebo in
Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or
Tamoxifen or No Therapy
Purpose of 1) To determine whether clodronate will improve DFS relative to placebo in
Study: patients who are receiving no adjuvant therapy or adjuvant systemic chemo-
therapy and/or tamoxifen.
2) To determine whether clodronate will improve the incidence of non-skeletal
metastates or reduce the incidence of skeletal morbidity relative to placebo
in patients who are receiving no adjuvant therapy or adjuvant systemic che-
motherapy and/or tamoxifen.
Study Chairs: Edith A. Perez, M.D. NCCTG Study
Chair:
Status: 01/30/2003 Activated Projected Number of Patients: 3200
03/31/2004 Perm. Closed
Schema: Randomize
Group 1: Clodronate 1600 mg/day X 3 years
Group 2: Placebo X 3 years
This is an NSABP coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study B-35 - September 2007
A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal
Patients with Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy with
Radiation Therapy
Purpose of 1) To compare the value of 1 mg/day of anastrozole to 20 mg/day of tamoxifen,
Study: each given for 5 years, in preventing the subsequent occurrence of breast
cancer (local, regional, and distant recurrences, and contralateral breast can-
cer) following lumpectomy with radiation therapy in hormone-receptor pos-
itive postmenopausal women with ductal carcinoma in situ (DCIS).
Study Chairs: R. Margolese M.D. NCCTG Study B. A. Mincey, M.D.
Chair:
Status 01/06/2003 Activated Projected Number of Patients: 3000
Schema: Randomize
Group 1: Tamoxifen + Breast Radiation Therapy
Group 2: Anastrozole + Breast Radiation Therapy
This is an NSABP coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study B-36 - September 2007
Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and
Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophospha-
mide (AC) With or Without Celecoxib, in Patients with Node-Negative Breast
Cancer
Purpose of 1) To assess the superiority of FEC-100 to AC in prolonging disease-free sur-
Study: vival in women with node-negative breast cancer.
Study Chairs: Edith A. Perez, M.D. NCCTG Study
Chair:
Status: 07/14/2004 Activated Projected Number of Patients: 2700
Schema: Randomize
Arm A: AC x 4 cycles
Arm B: FEC x 6 cycles
This is an NSABP coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study B-38 - April 2007
A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in
Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclo-
phosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Fol-
lowed by DD Paclitaxel (DD AC -->P); DD AC Followed by DD Paclitaxel plus
Gemcitabine (DD AC -->PG)
Purpose of - Primary Aims:
Study: 1) To determine whether a regimen of dose-dense doxorubicin and cyclophos-
phamide followed by dose-dense paclitaxel and gemcitabine (DD AC -->
PG) will be superior to a regimen of docetaxel, doxorubicin and cyclophos-
phamide (TAC) as well as to a regimen of dose-dense doxorubicin and
cyclophosphamide followed by dose-dense paclitaxel alone (DD AC --P) in
improving disease-free survival (DFS).
2) To compare the relative DFS of TAC and DD AC -->P.
- Secondary Aims:
1) To determine whether a regimen of DD AC -->PG will be superior to a regi-
men of TAC as well as to a regimen of DD AC -->P in improving survival
(S), recurrence-free interval (RFI), and distant recurrence-free interval
(DRFI).
2) To compare S, RFI, and DRFI between TAC and DD AC -->P.
3) To determine the relative toxicities of DD AC -->PG, TAC, and DD AC --
>P.
Study Chairs: S. Swain, M.D. NCCTG Study
Chair:
Status: 10/01/2004 Activated Projected Number of Patients: 4800
Schema:
Group 1 Group 2 Group 3
Doxorubicin - 50 mg/m2 Doxorubicin - 60 mg/m2 Doxorubicin - 60 mg/m2
Cyclophosphamide - 500 mg/m2 Cyclophosphamide - 600 mg/m2 Cyclophosphamide - 600 mg/m2
Docetaxel - 75 mg/m2 q 2 weeks x 4 cycles q 2 weeks x 4 cycles
q 3 weeks x 6 cycles
Paclitaxel - 175 mg/m2 Paclitaxel - 175 mg/m2
q 2 weeks x 4 cycles Gemcitabine - 2000 mg/m2
Hormonal Therapy q 2 weeks x 4 cycles
Hormonal Therapy
Hormonal Therapy
This is an NSABP coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study B-39 - September 2007
A Randomized Phase III Study of Conventional Whole Breast Irradiation
(WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I or II
Breast Cancer
Purpose of 1) To assess the effectiveness of partial breast irradation to whole breast irradi-
Study: ation in providing equivalent local tumor control in the breast following
lumpectomy for early stage breast cancer.
2) To compare overall survival, recurrence-free survival, and disease-free sur-
vival between women receiving partial breast irradiation and women receiv-
ing whole breast irradiation.
3) To examine cosmesis, fatigue, treatment related symptoms and preceived
convenience of care in each treatment group.
Study Chairs: Laura A. Vallow, M.D. NCCTG Study
Chair:
Status: 03/29/2005 Activated Projected Number of Patients: 3000
Schema: Randomize
Arm A: whole breast irradiation
Arm B: partial breast irradiation
This is a NSABP/RTOG coordinated study. The full report from the coordinating group can be
viewed as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study E2100 - September 2007
A Randomized Phase III Trial of Paclitaxel versus Paclitaxel plus Bevaci-
zumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Met-
astatic Breast Cancer
Purpose of 1) To determine the time to treatment failure of patients with chemotherapy
Study: naive metastatic breast cancer randomized to treatment with either pacli-
taxel alone or paclitaxel plus bevacizumab.
2) To compare the toxicity profile, objective response rate, duration of
response, and overall survival of paclitaxel to that of paclitaxel plus bevaci-
zumab.
Study Chairs: Edith A. Perez, M.D. NCCTG Study
Chair:
Status: 04/25/2002 Activated Projected Number of Patients: 685
05/25/2004 Perm. Closed
Schema: Randomize
Arm A: Paclitaxel plus Bevacizumab
Arm B: Paclitaxel
The final study summary appeared in the on-line Spring 2007 Meeting Book. Results were also
reported in a San Antonio Breast Cancer Symposium 2005 abstract:
Miller KD, Wang M, Gralow J, Dickler M, Cobleigh MA, Perez EA, Shenkier T, Davidson NE.
A randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first-line therapy
for locally recurrent or metastatic breast cancer: a trial coordinated by the Eastern Cooperative
Oncology Group (E2100). SABCS 2005, Abstract 3.
NCCTG Status Report for Study MA.20 - September 2007
A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
Purpose of 1) To compare overall survival, disease-free survival, isolated local regional
Study: disease free survival, distant disease free survival, toxicity, quality of life
and cosmetic outcome in women who have node positive or high risk node
negative breast cancer treated with breast conserving therapy and who are
randomized to receive standard breast radiation or breast radiation plus
regional radiation.
Study Chairs: I. Ackerman NCCTG Study
V. Benk Chair: L. Vallow
J. Bowen
T. Whelan
B. Chua
P. Craighead
M. Levine
D. McCready
M. Nolan
I. Olivotto
D. Parda
K. Pritchard
K. Vallis
L. Vallow
T. Whelan
J. White
Status: 12/14/1999 Activated Projected Number of Patients: 1822
Schema: Randomize
Arm 1: Standard Breast Radiation (Control)
Arm 2: Breast Radiation plus Regional Radiation (Experimental)
This is an NCIC CTG coordinated study. The full report from the coordinating group can be
viewed as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study MA.21 - September 2007
A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Fol-
lowed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF
as Therapy for Premenopausal Women and Early Postmenopausal Women
Who Have Had Potentially Curative Surgery for Node Positive or High Risk
Node Negative Breast Cancer
Purpose of 1) To compare the disease-free survival and overall survival among women
Study: with high risk operable breast cancer following surgical resection of all
known disease who are randomized to receive CEF or EC --> T or AC --> T.
Study Chairs: Edith A. Perez, M.D. NCCTG Study
Chair:
Status: 11/16/2002 Activated Projected Number of Patients: 2100
04/29/2005 Perm. Closed
Schema: Randomize
Arm A: CEF
Arm B: EC --> T
Arm C: AC --> T
This is an NCIC CTG coordinated study. The full report from the coordinating group can be
viewed as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study MA.27 - September 2007
A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmeno-
pausal Women with Receptor Positive Primary Breast Cancer
Purpose of 1) To determine whether event-free survival differs between women treated
Study: with exemestane and women treated with anastrozole.
2) To compare fracture incidence, cardiovascular morbidity and mortality and
overall toxicity profiles in the treatment groups.
Study Chairs: James N. Ingle, M.D. NCCTG Study
Chair:
Status: 07/29/2003 Activated Projected Number of Patients: 6830
Schema: Randomize
Arm 1: Exemestane 25 mg/day x 5 years
Arm 2: Anastrozole 1 mg/day x 5 years
This is an NCIC CTG coordinated study. The full report from the coordinating group can be
viewed as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study S0221 - September 2007
Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC,
Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as
Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node Nega-
tive Breast Cancer
Purpose of 1) To compare two different schedules of doxorubicin and cyclophosphamide
Study: in terms of the disease-free survival, overall survival, and toxicity in patients
with node positive or high risk node negative breast cancer.
2) To compare two different schedules of paclitaxel administration in terms of
disease-free survival, overall survival, and toxicity in patients with node
positive or high risk node negative breast cancer.
Study Chairs: Timothy J. Hobday, M.D. NCCTG Study
Chair:
Status: 01/14/2004 Activated Projected Number of Patients: 4500
Schema: Randomize
Arm 1: AC q2wks x 6 --> taxol q2wks x6
Arm 2: (A wkly/C dly + pegfilgrastim) x 15 wks --> taxol q2wks x 6
Arm 3: AC q2wks x 6 --> taxol wkly x 12
Arm 4: (A wkly/C dly + pegfilgrastim) x 15 wks --> taxol wkly x 12
This is a SWOG coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Other Closed BREAST Trials - September 2007
MA.17 * A Phase III Randomized Double Blind Study of Letrozole Versus Placeboin
Women With Primary Breast Cancer Completing Five or More Years of
Adjuvant Tamoxifen
* Closed: 08/30/2002
* The impact of 5 years of letrozole relative to placebo in patients
with breast cancer who were disease-free after 5 years of tamoxifen by
estrogen receptor/progestrone receptor status of the primary tumor was
reported in Journal of Clinical Oncology 25(15):2006-2011, May 2007.
The abstract from this paper is presented below.
Purpose
Controversy exists regarding estrogen (ER) and progesterone (PgR) receptor
expression on efficacy of adjuvant endocrine therapy. In the ATAC (Arimi-
dex, Tamoxifen, Alone or in Combination) trial, the benefit of anastrozole
over tamoxifen was substantially greater in ER + /PgR- than ER +/PgR+
tumors. In BIG 1-98 (Breast International Group), the benefits of letrozole
over tamoxifen were the same in ER+ tumors irrespective of PgR. MA.17
randomized postmenopausal women after 5 years of tamoxifen, to letrozole
or placebo. We present outcomes according to tumor receptor status.
Patients and Methods
Disease-free survival (DFS) and other outcomes were assessed in subgroups
by ER and PgR status using Cox’s proportional hazards model, adjusting for
nodal status and prior adjuvant chemotherapy.
Results
The DFS hazard ratio (HR) for letrozole versus placebo in ER + /PgR+
tumors (N=3,809) was 0.49 (95% CI, 0.36 to 0.67) versus 1.21 (95% CI,
0.63 to 2.34) in ER + /PgR- tumors (N=636). ER + /PgR+ letrozole patients
experienced significant benefit in distant DFS (DDFS; HR=0.53; 95% VI,
0.35 to 0.80) and overall survival (OS; HR=0.58, 95% CI, 0.37 to 0.90). A
statistically significant difference in treatment effect between ER + /PgR+
and ER + /PgR- subgroups for DFS was observed (P=.02), but not for DDFS
(P=.06) or OS (P=.09).
Conclusion
These results suggest greater benefit for letrozole in DFS, DDFS, and OS in
patients with ER + /PgR+ tumors, implying greater activity in letrozole in
tumors with a functional ER. However, because this is a subset analysis and
receptors were not measured centrally, we caution against using these
results for clinical decision making.
BREAST NCCTG BREAST Committee Other Closed Trials - Page 1 of 1
Protocol Concepts for BREAST - September 2007
N0632 Phase II Trial of Vinflunine and Capecitabine in Previously TreatedMeta-
static Breast Cancer
Purpose of - Primary Goal
Study: 1) To evaluate the tumor response rate of the combination of vinflunine plus
capecitabine in patients with clinical evidence of metastatic disease, previ-
ously treated with at least one chemotherapy.
- Secondary Goal
1) To describe the adverse event profile of vinflunine plus capecitabine in
patients with refractory metastatic breast cancer (adverse events graded
using the NCI CTCAE v3.0).
2) To describe the progression-free survival times of patients receiving vin-
flunine plus capecitabine.
3) To describe the overall survival of patients receiving vinflunine plus capecit-
abine.
4) To describe the duration of response in patients receiving vinflunine plus
capecitabine.
5) To describe the time to treatment failure in patients receiving vinflunine plus
capecitabine.
6) To describe the QOL of patients receiving vinflunine plus capecitabine.
Schema: Register
Vinflunine + Capecitabine
*****************************************************************************
N063D BIG 2-06/N063D, ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treat-
mentOptimisation Trial - A randomized, multi-centre, open label, phase
IIIstudy of adjuvant lapatinib, trastuzumab, their sequence and theircom-
bination in patients with HER2/ErbB2 positive primary breast cancer
Purpose of - Primary Goal
Study: 1) To compare disease-free survival in patients with HER2 overexpressing and/
or amplified breast cancer randomized following anthracylcline-based che-
motherapy to trastuzumab (1 yr) vs lapatinib (1 yr) vs trastuzumab (12 wk)
-> washout (6 wk) -> lapatinib (34 wk) vs trastuzumab + lapatinib (1 yr).
- Secondary Goals
1) To compare overall survival, time to recurrence, time to distant recurrence,
and cumulative incidence of brain metastases as the site of first breast cancer
recurrence among the four treatment groups.
2) To evaluate safety and tolerability of the four regimens.
BREAST NCCTG BREAST Committee Protocol Concepts - Page 1 of 3
Protocol Concepts for BREAST - September 2007
3) To conduct all analyses separately for cohorts definded by cMyc, PTEN, and
p95 status.
Schema: Randomize
Trastuzumab
Lapatinib
Trastuzumab --> Washout --> Lapatinib
Trastuzumab + Lapatinib
*****************************************************************************
N063I Changes in Breast Density and Plasma Hormone Levels After One Year
ofAromatase Inhibitor Therapy
Purpose of 1) To assess the changes in percent breast density in response to one year of
Study: aromatase inhibitor therapy from levels prior to the initiation of treatment.
2) To assess the changes in dense area in response to one year of aromatase
inhibitor therapy from levels prior to the initiation of treatment.
3) To examine whether changes in percent breast density in response to one
year of aromatase inhibitor therapy from pre-treatment levels correlate with
changes in plasma hormones (estrone, estrone-sulfate, estradiol, SHBG) and
drug levels (anastrozole or exemestane) over the same time period.
4) To examine whether changes in dense area in response to one year of aro-
matase inhibitor therapy from pre-treatment mammogram correlate with
changes in plasma hormones (estrone, estrone-sulfate, estradiol, SHBG)
drug levels (anastrozole or exemestane) over the same time period.
5) To assess whether women with high pre-treatment dense area (upper tertile)
experience greater decreases in percent breast density after one year of aro-
matase inhibitor therapy than women with low pre-treatment percent density
(lower tertile).
6) To assess whether women with high pre-treatment dense area (upper tertile)
experience greater decreases in dense area after one year of aromatase inhib-
itor therapy than women with low pre-treatment dense area (lower tertile).
Schema: Registration
Observe for one year while receiving aromatase inhibitor therapy
Materials to be submitted include:
Blood sample collected prior to and 1 year post treatment
Signed authorizaton form to release mammograms taken prior to and
1 year post treatment
Patient Questionnaire completed prior to start of treatment
BREAST NCCTG BREAST Committee Protocol Concepts - Page 2 of 3
Protocol Concepts for BREAST - September 2007
*****************************************************************************
N0733 Phase II Trial of IMC-A12 in combination with Capecitabine andLapatinib
in Patients with HER2 Positive, Trastuzumab-Resistant BreastCancer Pre-
viously Treated with an Anthracycline and a Taxane
Purpose of - Primary Goal
Study: 1) To compare 6-month progression-free survival rates of lapatinib and
capecitabine +/- IMC-A12 in HER2+ breast cancer patients previously
treated with trastuzumab and chemotherapy.
- Secondary Goals
1) To determine overall survival rate, progression-free survival rate, time to
treatment fairlure, tumor response rate, and duration of response of lapatinib
and capecitabine +/- IMC-A12.
2) To assess the safety and tolerability of lapatinib and capecitabine +/- IMC-
A12.
Schema: Randomization
IMC-A12 + Capcitabine + Lapatinib
Capecitabine + Lapatinib
*****************************************************************************
N0735 Phase II Trial of nab (nanoparticle albumin bound)-Paclitaxel(nab-pacli-
taxel; Abraxane) in Combination with Gemcitabine andBevacizumab in
Patients with Metastatic Breast Cancer
Purpose of - Primary Goal
Study: 1) To assess the efficacy of nab-paclitaxel + gemcitabine + bevacizumab in
patients with metastatic breast cancer using a one-stage phase II study
design.
- Secondary Goals
1) Survival
2) Progression-free survival
3) Duration of response
4) Time to treatment failure
5) Adverse event profile
Schema: Registration
Nab-paclitaxel + Gemcitabine + Bevacizumab
BREAST NCCTG BREAST Committee Protocol Concepts - Page 3 of 3
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LUNG PROGRAM
For the first three months of 2007 (data as of March 9, 2007), a total of 116
patients have been accrued to treatment trials. This is down from our monthly accrual
goal is 28 patients and if this trend continues our target accrual will be below the
expected goal of 300 patients a year.
Small Cell Lung Cancer
We have two front lines studies for extensive stage SCLC, The first study,
N0621, is a Phase II Study of the c-SRC Inhibitor, AZD0530 after Four Cycles of
Cytoreductive Chemotherapy for Patients with Untreated Extensive Stage Small Cell
Carcinoma, this study will be open for accrual in a couple of weeks. Our second study is
N0423, a phase II trial of the combination of pemetrexed and carboplatin in extensive
stage small cell which has been open for accrual since February 3, 2006. This trial has
enrolled 43 patients to date. We completed accrual of S0124 (irinotecan/cisplatin versus
etoposide/cisplatin) on March 1st 2007.
Non-Small Cell Lung Cancer
For Stage IIIB/pleural effusion Stage IV: our current front line study is
N0528: A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without
AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer. This study
opened a few weeks ago and is accruing slowly.
N0323 (phase II trial of CCI-779) opened in April 2004 and completed the
anticipated accrual target of 55 patients in November 2006. The clinical response rate of
N0323 was 38% (8% PR and 30% SD). This study did not meet the predefined success
criteria. N0426, a second-line phase II treatment trial of Alimta and bevacizumab, opened
in May 2006 and completed accrual (48 patients) in a record time (02/23/2007). Analysis
of this trial is pending. N0326 (sorafenib) is a phase II trial for previously untreated stage
IV non-small cell lung cancer. It opened in February of 2005 and was closed in August
of 2006 due to lack of efficacy.
The selenium/placebo chemoprevention trial (E5597) is experiencing slow
national accrual. NCCTG accrual is only 2 patients in 2006 and 1 patient in 2007 about
4% of the total national accrual (82 patients). This trial is very easy to accrue to with
essentially no toxicity and offers cancer control credits. Talk to your thoracic surgeons
and arrange to see these early stage (Stage IA) resected patients in follow up. We
currently do not have an adjuvant therapy trial.
For Stage IIIA/B unresectable NSCLC we currently have two active studies.
N0321 is a Phase I/II trial that combine radiation therapy with PS341. This study is
currently open and 15 patients have been accred so far. This is the first NCCTG trial
incorporating novel agents with radiotherapy for lung cancer.
N0422 opened to NCCTG on Jan 27, 2006. This trial has accrued 23 patients
since opening; it combines Cetuximab (C225) and Radiation in Elderly (patients ≥ 65
years of age with PS ≤ 2) and Poor Performance Patients (patients less than 65 years with
PS = 2) with Locally Advanced (stage IIIA/IIIB without a malignant pleural effusion)
Non-Small Cell Lung Cancer.
In general, radiotherapy trials are accruing very poorly. We need significant help
from both the radiation oncology and medical oncology community if we are going to
keep these combined modality trials viable.
Mesothelioma
N0623: Phase II Study of GW786034 in Patients with Malignant Pleural
Mesothelioma. This is a front line study of GW786034 (Pazopanib) a small molecule
tyrosine kinase inhibitor of VEGFR is now open.
Open Trials
Small Cell Lung Cancer
• N0423: Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously
Untreated Extensive Stage Small Cell Lung Cancer
Non-small Cell Lung Cancer
Stage IIIA/IIIB
• N0321. Phase I/II Study of PS-341 in Combination with Paclitaxel,
Carboplatin, and Concurrent Thoracic Radiation Therapy for Non-small Cell
Lung Cancer (NSCLC)
• N0422: Cetuximab (C225) and Radiation in Elderly and Poor Performance
Patients with Locally Advanced Non-Small Cell Lung Cancer: A Phase II
Study to Evaluate Survival and Toxicity
• R0214 Phase III trial of prophylactic cranial irradiation versus observation in
patients with locally advanced NSCLC
Stage IIIB/IV
• N0528: A Randomized Phase II Study of Gemcitabine and Carboplatin With
or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell
Lung Cancer.
Early Stage Lung Cancer Going to Surgery (neoadjuvant therapy)
• S0220 Phase II trial of chemoradiotherapy and surgery for Pancoast tumor
Surgical Adjuvant Therapy
• ECOG 5597 Selenium trial for lung cancer chemoprevention (resected stage
IA or IB)
Mesothelioma
N0623: Phase II Study of GW786034 in Patients with Malignant Pleural
Mesothelioma.
Correlative study
• S0424: NSCLC Molecular Epidemiology (opened 1/30/2006, accrual 47).
Trials Expected to open 2007
Phase II
• N0621: Phase II Study of the c-src Inhibitor, AZD0530, After Four Cycles of
Cytoreductive Chemotherapy for Patients with Untreated Extensive Stage
Small Cell Carcinoma
Phase III
• A Phase III Biomarker Validation study of Second-line Therapy in Patients With
Advanced Non-Small Cell Lung Cancer (NSCLC) randomized to Pemetrexed
Versus Erlotinib
Program Status Reports for LUNG - September 2007
Small cell: Open
N0423 Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously-
Untreated Extensive Stage Small Cell Lung Cancer
Non-Small Cell: Open
E5597 Phase III Chemoprevention Trial of Selenium Supplementation in Per-
sonsWith Resected Stage I Non-Small Cell Lung Cancer
N0028 Phase I/II Study of Concurrent Chemotherapy and Escalating Doses 3-
DConformal Radiotherapy (RT) Followed by Three Cycles of Chemo-
therapyfor Unresectable Non-Small Cell Lung Cancer (NSCLC) Using a
New RTParadigm
N0321 Phase I/II Study of PS-341 in Combination with Paclitaxel,Carboplatin,
and Concurrent Thoracic Radiation Therapy for Non-smallCell Lung
Cancer (NSCLC)
N0422 Cetuximab (C225) and Radiation in Elderly and/or Poor PerformanceS-
tatus Patients with Locally Advanced Non-Small Cell Lung Cancer:
APhase II Study to Evaluate Survival and Toxicity
N0528 A Randomized Phase II Study of Gemcitabine and Carboplatin With
orWithout AZD2171 as First-Line Therapy in Advanced Non-Small
Cell LungCancer
S0220 A Phase II Trial of Induction Chemoradiotherapy withCisplatin/Etopo-
side Followed by Surgical Resection Followed byDocetaxel for Non-
Small Cell Lung Cancer Involving the Superior Sulcus(Pancoast
Tumors)
Non-Small Cell: Closed
N0323 A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients WithAd-
vanced Non-Small Cell Lung Cancer
N0426 A Phase II Study of Pemetrexed Disodium (ALIMTA) Plus Bevaci-
zumab inPatients with Stage IIIB Pleural Effusion or Stage IV Non-
Small CellLung Cancer (Second-Line Treatment)
LUNG NCCTG LUNG Committee Table of Contents - Page 1 of 3
Program Status Reports for LUNG - September 2007
Mesothelioma: Open
E1B03 Pemetrexed Plus Gemcitabine or Carboplatin in Patients with
AdvancedMalignant Mesothelioma: A Randomized Phase II Trial
N0623 Phase II Study of GW786034 in Patients with Malignant PleuralMe-
sothelioma
Other Closed Trials
952053 A Pilot Study of High-Dose Thoracic Radiation Therapy With Concom-
itantCisplatin/Etoposide in Limited-Stage Small Cell Lung Cancer
972451 Phase III Randomized, Double-Blind Study of CAI and Placebo inPa-
tients With Advanced Non-Small Cell Lung Cancer (NSCLC)
N0021 Phase II Study of Gemcitabine and Epirubicin for the Treatment ofMe-
sothelioma
N0027 Phase II Trial of Oral Topotecan and Intravenous Carboplatin withG-
CSF (Filgastim) Support in Previously Untreated Patients withExtensive
Stage Small Cell Lung Cancer
N0222 Parallel Phase II Trials of ZD1839 (Iressa) Alone or WeeklyCarboplatin
and Paclitaxel Followed by ZD1839 (Iressa) (OncologistsMust Choose)
for Metastatic Non-Small Cell Lung Cancer in Patients>=65 Years of
Age
N0326 Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in PatientsWith
Advanced Non-Small Cell Lung Cancer
CTSU
0214-CTSU A Phase III Comparison of Prophylactic Cranial Irradiation VersusOb-
servation in Patients with Locally Advanced Non-Small Cell LungCan-
cer
BR.19 A Phase III Prospective Randomized, Double-Blind, Placebo-Con-
trolledTrial of the Epidermal Growth Factor Receptor Antagonist
ZD1839(Iressa) in Completely Resected Primary Stage IB, II and
IIIANon-Small Cell Lung Cancer
LUNG NCCTG LUNG Committee Table of Contents - Page 2 of 3
Program Status Reports for LUNG - September 2007
S0124 Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-
616348)Versus Cisplatin and Etoposide in Patients with Extensive Stage
SmallCell Lung Cancer (E-SCLC)
S9925 Lung Cancer Specimen Repository Protocol, Ancillary Study to S9900
Protocol Concepts
N0621 Phase II Study of the c-SRC Inhibitor, AZD0530, After Four Cycles
ofCytoreductive Chemotherapy for Patients With Extensive Stage
SmallCell Carcinoma
N0626 A Phase II Randomized Study of Pemetrexed Combined With Sor-
afenibVersus Pemetrexed Alone as Second-line Therapy in Patients
WithAdvanced Non-Small Cell Lung Cancer
N0723 A Phase III Biomarker Validation Study of Second-Line Therapy inPa-
tients With Advanced Non-Small Cell Lung Cancer (NSCLC) Random-
izedto Pemetrexed Versus Erlotinib
N0724 A Phase II Study of the Treatment of Oligometastatic Stage IVNon-
Small Cell Lung Cancer (NSCLC) with Systemic Therapy plusRadio-
therapy to all Sites of Gross Disease
LUNG NCCTG LUNG Committee Table of Contents - Page 3 of 3
NCCTG Status Report for Study N0423 - September 2007
Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously
Untreated Extensive Stage Small Cell Lung Cancer
Purpose of - Primary
Study: 1) To evaluate the complete and partial response rate of pemetrexed disodium
and carboplatin in previously untreated patients with extensive-stage SCLC.
- Secondary
1) To evaluate the toxicity of this combination in untreated patients with exten-
sive stage SCLC.
2) To obtain preliminary estimates of survival for this combination regimen.
3) To obtain preliminary estimates of response rate and toxicity in patients 70
years and older.
- Translational
1) To correlate survival outcomes with data obtained from pharmacogenetic
studies relevant to pemetrexed disodium.
2) To bank paraffin-embedded tissue block/slides from patients enrolled in this
trial that could be used for furture evaluation of pharmacogenetic and/or
proteomic markers.
3) To assess the presence and concentration of circulating tumor cells in
peripheral blood of patients with SCLC undergoing chemotherapy.
4) To explore the potenital as predictor for risk of recurrence of having residual
circulating tumor cells during and after the completion of chemotherapy
treatment for SCLC.
5) To establish a bank of cells isolated before and after chemotherapy as a tool
for furture genomic and proteomic studies of factor involved in resistance
from chemotherapy.
Study Chairs: James R. Jett M.D. QC Specialist: Jennifer P Schreiber
Albert M. Bernath Jr. M.D.
Statistician: Nathan R. Foster M.S. Nurse Resource: Wanda L. DeKrey R.N.,
OCN
Status: 02/03/2006 Activated Projected Number of Patients: 77
Excluded: 2 Final Accrual: NA
Stratification None
Factors:
Schema: Reg
Pemetrexed disodium/carboplatin
Treating Schedule:
LUNG NCCTG LUNG Committee N0423 - Page 1 of 5
NCCTG Status Report for Study N0423 - September 2007
Arm Agent Dose Route Days Freq
ALIMTA 500 mg/m2 100 mL NS IV infusion 1 Every 21 days (=70) sep-
arately.
In the younger cohort, 46 evaluable patients will be entered. If 22 or fewer successes (con-
firmed-tumor response) are observed, we will consider this regimen ineffective in this patient
population. If 23 or more successes are observed, this will be considered evidence that this
treatment may be recommended for further testing in subsequent studies.
In the elderly cohort, 24 evaluable patients will be entered. If 12 or fewer successes are
observed, we will consider this regimen ineffective in this patient population. If 13 or more suc-
cesses are observed, this will be considered evidence that this treatment may be recommended
for further testing in subsequent studies.
Accrual: When the data was frozen for this report on August 6, 2007, this study had accrued 27
patients to the age group less than 70 and 16 patients to the age group greater than or equal to 70.
See Accrual Table for details on the total membership accrual to this study.
Patient Characteristics: The distribution of patient characteristics at study entry is located in
the Baseline Characteristics Table.
Adverse Events: There are 32 patients evaluable for adverse events at the time of this report.
Of these 32 patients, 22 (69%) experienced at least one grade 3+ adverse event (AE) and 12
(38%) experienced at least one grade 4+ AE.
Twenty-one patients were evaluable in the age group less than 70 years of age. Of these 21
patients, 15(71%) experienced at least one grade 3+ adverse event and 7 (33%) experienced at
least one grade 4+ adverse event. One grade 5 event was just recently reported through the
expedited reporting system for adverse events. This patient died at home due to unknown
causes. This death was possibly related to the study treatment.
LUNG NCCTG LUNG Committee N0423 - Page 2 of 5
NCCTG Status Report for Study N0423 - September 2007
Eleven patients were evaluable for AEs in the age group greater than or equal to 70 years of age.
Of these 11 patients, 7 (64%) experienced at least one grade 3+ AE and 5 (45%) experienced at
least one grade 4+ AE. Two patients experienced grade 5 AEs. One patient died of a blood
infection that was thought to be definitely related to treatment, and another patient died from a
grade 5 dyspnea, that was thought to be unrelated to the study treatment.
More details are presented in the attached Adverse Event Table.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Ann Arbor 1 1 1
Carle 3 2 3
Cedar Rapids 2 2 2
Dayton 2 2 2
Des Moines 2 0 2
Duluth 7 2 7
Fargo 4 1 3
Geisinger 3 2 3
Grand Forks 2 0 2
Lehigh 1 1 1
MN CGOP 1 1 1
Mayo 3 1 1
Metro MN 4 1 2
N Indiana 2 2 2
Oklahoma 2 1 2
Peoria 1 1 1
Scottsdale 3 1 2
Total Membership Accrual 43 21 37
LUNG NCCTG LUNG Committee N0423 - Page 3 of 5
NCCTG Status Report for Study N0423 - September 2007
Baseline Characteristics Table:
Arm
Characteristics
A
Age Group
= 70 years 16
Brain Metastasis at on study
Yes 5
No 38
Gender
Female 17
Male 26
Number of Metastatic Sites
1 8
>=2 35
Prior Palliative Radiation
Yes 5
No 38
Race
White 41
American Indian or Alaska Native 1
Not reported: patient refused or not ava 1
Whole Brain RT
Yes 5
No 38
LUNG NCCTG LUNG Committee N0423 - Page 4 of 5
NCCTG Status Report for Study N0423 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 32
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 15 47 5 16 7 22 0 0
LEUKOPENIA A 2 6 2 6 0 0 0 0
ANEMIA A 26 81 4 13 0 0 0 0
THROMBOCYTOPENIA A 12 38 1 3 7 22 0 0
Cardiovascular THROMBOSIS A 0 0 2 6 1 3 0 0
Constitutional Symptoms FATIGUE A 24 75 4 13 1 3 0 0
Dermatology/Skin ALOPECIA A 11 34 0 0 0 0 0 0
RASH A 12 38 0 0 0 0 0 0
Gastrointestinal ANOREXIA A 4 13 3 9 0 0 0 0
NAUSEA A 19 59 0 0 0 0 0 0
STOMATITIS A 4 13 0 0 0 0 0 0
VOMITING A 10 31 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 7 22 1 3 0 0 0 0
Oral cavity MS CE A 7 22 0 0 0 0 0 0
Infection/Febrile Neutropenia Blood Infectn A 0 0 0 0 0 0 1 3
Metabolic/Laboratory HYPERGLYCEMIA A 1 3 3 9 0 0 0 0
Pulmonary DYSPNEA A 20 63 1 3 1 3 1 3
Maximum Grade Adverse Event A 10 31 10 31 10 31 2 6
LUNG NCCTG LUNG Committee N0423 - Page 5 of 5
NCCTG Status Report for Study E5597 - September 2007
Phase III Chemoprevention Trial of Selenium Supplementation in Persons
With Resected Stage I Non-Small Cell Lung Cancer
Purpose of 1) To evaluate the efficacy of protocol treatment in reducing second primary
Study: lung tumors for the study population.
2) To evaluate the qualitative and quantitative toxicity of the study regimen.
3) To compare the incidence of specific cancers, mortality from cancer and
overall survival for patients enrolled on each treatment arm.
- Correlative Objectives
1) Determine the prevalence for methylation of p16, O6-methylguanine-DNA
methyltransferase, and death associated protein kinase in sputum and blood
after tumor resection and follow persons with positive methylation markers
longitudinally to determine how selenium alters their methylation profile.
2) In a nested, case-control study, determine whether changes in oxidative
stress damage and aberrant promoter hypermethylation predict Determine if
selenium supplementation decreases DNA oxidation products (5-hydroxym-
ethyldeoxyuridine) and 5-lipoxygenase metabolites (5-HETE, LTB4).
3) Determine whether the reduction of oxidative stress damage predicts loss of
the methylation marker(s) during treatment with selenium.
4) In a nested, case-control study, determine whether changes in oxidative
stress damage and aberrant promoter hypermethylation predicts develop-
ment of a second primary lung cancer.
Study Chairs: Randolph Stuart Marks M.D. QC Specialist: Paula J. Stellmaker
Martin Wiesenfeld M.D.
Statistician: Nurse Resource:
Status: 10/13/2000 Activated Projected Number of Patients: 1960
Excluded: 1 Final Accrual: NA
Stratification Smoking Status: actively smoking or stopped /=1 yr ago never smoked or 6 7
Phase of Study
Phase I (not MTD) 19
PreRx Supraclavicular Node Inv
Yes 4
No 15
Race
White 18
Black or African American 1
Weight Loss in past 3 months
=5% in past 6 mo
Yes 11
No 28
LUNG NCCTG LUNG Committee N0422 - Page 4 of 5
NCCTG Status Report for Study N0422 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 35
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology LEUKOPENIA A 8 23 0 0 0 0 0 0
THROMBOCYTOPENIA A 4 11 0 0 0 0 0 0
Cardiovascular THROMBOSIS A 0 0 0 0 1 3 0 0
Constitutional Symptoms FATIGUE A 15 43 5 14 0 0 0 0
Dermatology/Skin NAIL CHANGES A 5 14 0 0 0 0 0 0
RASH A 29 83 2 6 0 0 0 0
Gastrointestinal ANOREXIA A 6 17 5 14 0 0 0 0
NAUSEA A 15 43 1 3 0 0 0 0
STOMATITIS A 13 37 0 0 0 0 0 0
DEHYDRATION A 4 11 3 9 0 0 0 0
DYSPHASIA-PHARYN RT A 5 14 1 3 0 0 0 0
VOMITING A 9 26 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 5 14 2 6 0 0 0 0
Oral cavity MS CE A 13 37 0 0 0 0 0 0
PHARYNX MS CE A 5 14 0 0 0 0 0 0
PHARYNX MS FS A 10 29 1 3 0 0 0 0
Metabolic/Laboratory HYPOMAGNESEMIA A 13 37 1 3 1 3 0 0
Pain PAIN-HEADACHE A 4 11 0 0 0 0 0 0
Pulmonary DYSPNEA A 2 6 3 9 0 0 0 0
Death DISEASE PROGRESSION A 0 0 0 0 0 0 2 6
Maximum Grade Adverse Event A 18 51 14 40 1 3 2 6
LUNG NCCTG LUNG Committee N0422 - Page 5 of 5
NCCTG Status Report for Study N0528 - September 2007
A Randomized Phase II Study of Gemcitabine and Carboplatin With or With-
out AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
Purpose of - Primary Goal
Study: 1) To assess the objective tumor response rate among patients with NSCLC
receiving gemcitabine and carboplatin in combination with AZD2171 (Arm
A).
- Secondary Goals
1) To assess the proportion of patients who are progression-free at 6-months in
each treatment arm.
2) To assess the duration of response for reponding patients in each treatment
arm.
3) To assess the time-to-progression and time-to-treatment failure in each treat-
ment arm.
4) To assess the 1-year overall survival between the treatment arms.
5) To assess the clinical toxicities of each treatment arm.
6) To assess the safety and tolerability of the 45 mg daily dose of AZD2171 in
combination with gemcitabine and carboplatin.
- Translational
1) To collect blood and tumor specimens for future evaluation of pharmacoge-
netic and proteomic markers of tumor response and toxicity to therapy with
these agents. paraffin-embedded tissue blocks/slides and blood samples for
future histochemistry evaluation and DNA extraction.
2) To correlate quantitative changes in circulating endothelial cells and endot-
helial progenitor cells with clinical response and toxicity.
3) As part of ongoing research for NCCTG lung studies, we are banking paraf-
fin-embedded tissue blocks/slides and blood samples for future histochemis-
try evaluation and DNA extraction.
Study Chairs: Alex A. Adjei M.D. QC Specialist: Paula J. Stellmaker
Donald Wallace Northfelt M.D.
Statistician: Sumithra J. Mandrekar Ph.D. Nurse Resource: Wanda L. DeKrey R.N.,
OCN
Status: 06/15/2007 Activated Projected Number of Patients: 102
Excluded: None Final Accrual: NA
Stratification Prior adjuvant therapy: Yes vs. No ECOG PS: 0 vs. 1
Factors:
Schema: Registration
Randomize
Arm A (Gemcitabine, Carboplatin, AZD2171)
Arm B (Gemcitabine, Carboplatin)
LUNG NCCTG LUNG Committee N0528 - Page 1 of 2
NCCTG Status Report for Study N0528 - September 2007
Treating Schedule:
Arm Agent Dose Route Days Freq
A Gemcitabine 1000 mg/m2 IV infusion over 30 min- 1, 8 Every 21 days (+/- 2 days) maxi-
utes mum of 6 cycles***
A Carboplatin AUC 5 IV infusion over 30 min- 1 Every 21 days (+/- 2 days) maxi-
utes mum of 6 cycles***
A AZD2171** 45 mg* By mouth** Once daily Every 21 days (+/- 2 days)
B Gemcitabine 1000 mg/m2 IV infusion over 30 min- 1, 8 Every 21 days (+/- 2 days), maxi-
utes mum of 6 cycles
B Carboplatin AUC 5 IV infusion over 30 min- 1 Every 21 days (+/- 2 days), maxi-
utes mum of 6 cycles
*Take with 8 ounces of water. All 3 pills should be taken within 15
minutes - they need to be swallowed whole.
**AZD2171 must be taken on an empty stomach. Take 1 hour before a
meal or 2 hours after a meal.
***After 6 cycles of therapy, if patient has stable disease, partial
or complete response to treatment, patient will continue on AZD2171 as
noted.
Study Design: This randomized phase II study will assess the response rate (RR) in patients
with advanced NSCLC (Stage IIIB with pleural effusions or IV) receiving gemcitabine (G) and
carboplatin (C) in combination with AZD2171 using a one-stage design. In order to assess the
tolerability of a 45 mg daily oral dose of AZD2171 when combined with G and C for the front-
line treatment of advanced NSCLC, accrual to the study will be suspended for a minimum of 3
weeks (i.e. 1 cycle) once 6 patients are randomized to arm A. The success rate on the
G+C+AZD2171 (arm A) will be judged relative to the rate (point estimate) observed on G+C
arm (arm B) in this study. The largest success proportion where arm A would be considered 'not
promising' (ineffective) in this population is p0, and the smallest success proportion that would
warrant subsequent studies with the proposed regimen of arm A in this patient population is
p0+0.15. A maximum of 56 evaluable patients will be randomized to Arm A of the study and a
maximum of 28 evaluable patients will be randomized to Arm B using a 2:1 randomization
scheme. This trial is planned as a one-stage design since, at the anticipated accrual rate of 8
patients per month, we would be very close to our final accrual before patients would become
evaluable for an interim analysis. In addition, the addition of AZD2171 to G+C is not likely to
be inferior to just G+C, which is one of the current chemotherapy regimens in this patient popu-
lation.
Accrual: As of the freeze date of August 6, 2007, this study has accrued zero patients.
LUNG NCCTG LUNG Committee N0528 - Page 2 of 2
NCCTG Status Report for Study S0220 - September 2007
A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide
Followed by Surgical Resection Followed by Docetaxel for Non-Small Cell
Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
Purpose of 1) To assess overall survival in patients with Pancoast tumors without medias-
Study: tinal or supraclavicular nodal involvement treated with cisplatin and etopo-
side for two cycles, concurrent with a program of continuous, fractionated
chest radiation followed by surgical resection and consolidation chemother-
apy with docetaxel.
2) To assess time to progression, response (confirmed plus unconfirmed, com-
plete plus partial drug induction), resectability rates and toxicity in this
patient population treated with this regimen.
3) To investigate in an exploratory manner the association of p27, To investi-
gate in an exploratory manner the association of p27, TUBB-III and Map4
expression levels with patient responses and outcomes.
Study Chairs: James R. Jett M.D. QC Specialist:
Statistician: Nurse Resource:
Status: 12/19/2003 Activated Projected Number of Patients: 144
Excluded: None Final Accrual: NA
Stratification
Factors:
Schema: Registration
1) Cisplatin + Etoposide + Concurrent Radiotherapy
2) Surgical resection
3) Docetaxel
Treating Schedule:
Arm Agent Dose Route Days Freq
- Etoposide 50 mg/m2 IV 1-5 and 29-33 Induction only
- Cisplatin 50 mg/m2 IV 1, 8, 29 & 36 Induction only
- Docetaxel (Con- 75 mg/m2 IV 1 Every 21 days for 3 cycles
solidation Chemo-
therapy)
Arm Dose Days FX/Day FX/Size # FX RT Length
- 4500 cGy M-F 1 180 25 Weeks 1-5
LUNG NCCTG LUNG Committee S0220 - Page 1 of 2
NCCTG Status Report for Study S0220 - September 2007
Registration #1: Radiotherapy is to begin within 24 hours following
the start of chemotherapy. Day 1 of radiotherapy must be a Monday,
Tuesday or Wednesday, but no later in the week to insure simultaneous
therapy for the majority of each chemotherapy cycle. Induction
Chemotherapy. Patients not proceeding to surgery are to be continued
on radiation to a total dose of 6,100 - 6,120 cGy.
Registration #2: Surgery will be performed 3-7 weeks after completion
of chemoradiotherapy.
Registration #3: Consolidation chemotherapy will begin no sooner than
3 weeks and no more than 8 weeks after the operation.
LUNG NCCTG LUNG Committee S0220 - Page 2 of 2
NCCTG Status Report for Study N0323 - September 2007
A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced
Non-Small Cell Lung Cancer
Purpose of - Primary
Study: 1) To evaluate the response rate of CCI-779 in Stage IIIB (pleural effusion) or
IV non-small cell lung cancer patients.
2) To describe the clinical toxicities of CCI-779 in this patient population.
- Secondary
1) To assess the 24-week progression-free survival rate of CCI-779 in Stage
IIIB or IV NSCLC.
2) To evaluate the effect of CCI-779 on overall survival.
3) To evaluate the effect of CCI-779 on time-to-progression.
4) To evaluate predictive markers of activity of CCI-779 (PTEN mutations,
phosphoAkt expression).
5) To evaluate markers of target inhibition by CCI-779 (4EBP phosphoryla-
tion, inhibition of p70S6kinase phosphorylation).
Study Chairs: Alex A. Adjei M.D. QC Specialist: Paula J. Stellmaker
Donald Wallace Northfelt M.D.
Statistician: Sumithra J. Mandrekar Ph.D. Nurse Resource: Wanda L. DeKrey R.N.,
OCN
Status: 02/27/2004 Activated Projected Number of Patients: 55
11/03/2006 Perm. Closed
Excluded: 3 Final Accrual: 55
Stratification None
Schema: Register
A) CCI-779
Treating Schedule:
Arm Agent Dose Route Days Freq
A CCI-779 25 mg (flat) IV over 30 minutes in 250 1, 8, 15, 22 every 4 weeks
ml NS (non-PVC con-
tainer or glass)
CCI-779 dose is 25 mg total, i.e., it is not based on weight.
LUNG NCCTG LUNG Committee N0323 - Page 1 of 5
NCCTG Status Report for Study N0323 - September 2007
Study Design: This two-stage single arm Phase II study is designed to assess the confirmed
response rate in patients with stage IIIB/IV NSCLC to CCI-779. A maximum of 50 evaluable
patients will be accrued on this study. Based on a two-stage Fleming design with a positive stop-
ping rule, the treatment will be considered promising if at least 4 of the first 25 evaluable
patients in Stage I have a confirmed tumor response. The study will however proceed to stage 2
and accrue the additional 25 patients for the purposes of addressing the 24-week progression
free survival rate, to obtain more information on the toxicity profile, and to gain better precision
for the confidence intervals of the response proportion. If at least 6 of the 50 evaluable subjects
have a confirmed tumor response, this will again be considered as evidence of promising activ-
ity. The trial also allows for early termination if insufficient response or excessive toxicity is
observed.
Accrual: Fifty-five patients were accrued to this study. One patient was deemed cancelled
since they did not receive study treatment, one patient was deemed ineligible due to the fresh
tumor biopsies not done at the site, and one patient was deemed ineligible due to nonmeasurable
disease.
Patient Characteristics: The distribution of patients at study entry is located in the Baseline
Characteristics Table.
Adverse Events: Adverse event data is available on all 52 evaluable patients who received
study treatment. Thirty-three (64%) patients experienced grade 3+ adverse events. Twelve
(23%) patients experienced the following grade 4/5 adverse events: 1 grade 5 bronchitis NOS; 1
grade 4 bone pain and grade 5 depression; 1 grade 4 bone pain and grade 5 disease progression;
1 grade 4 anemia and grade 5 necrosis; 1 grade 5 ischemia/infarction; 1 grade 4 dyspnea, vascu-
lar access complications and grade 5 death NOS; 1 grade 4 lung injury; 1 grade 5 sudden death;
and 4 grade 5 disease progressions. None of these grade 4/5 events were considered related to
treatment.
More details on adverse events (regardless of attribution to study treatment) for the 52 evaluable
patients are presented in the Adverse Events Table.
Study Status: The study permanently closed on November 3, 2006 after meeting the accrual
objective.
LUNG NCCTG LUNG Committee N0323 - Page 2 of 5
NCCTG Status Report for Study N0323 - September 2007
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Carle 13 0 0
Fargo 5 0 0
Geisinger 1 0 0
Grand Forks 2 0 0
Green Bay 1 0 0
Hawaii CCOP 3 0 0
Mayo 10 0 0
Peoria 4 0 2
Scottsdale 1 0 0
Sioux City 2 0 0
Sioux Falls 1 0 0
St. Cloud 4 0 0
Wichita 8 0 0
Total Membership Accrual 55 0 2
Baseline Characteristics Table:
Arm
Characteristics
A
Gender
f 22
m 33
LUNG STAGE
IIIB 10
IV 45
Performance Score
0 25
1 24
2 6
Race
White 52
Native Hawaiian or Other Pacific Islande 1
Asian 2
LUNG NCCTG LUNG Committee N0323 - Page 3 of 5
NCCTG Status Report for Study N0323 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 52
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 12 23 0 0 0 0 0 0
LEUKOPENIA A 14 27 0 0 0 0 0 0
ANEMIA A 30 58 1 2 1 2 0 0
LYMPHOPENIA A 5 10 1 2 0 0 0 0
THROMBOCYTOPENIA A 12 23 0 0 0 0 0 0
Cardiovascular ISCHEMIA/INFARCTION A 0 0 0 0 0 0 1 2
Constitutional Symptoms FATIGUE A 25 48 5 10 0 0 0 0
WEIGHT LOSS A 8 15 0 0 0 0 0 0
Dermatology/Skin RASH A 19 37 3 6 0 0 0 0
Gastrointestinal ANOREXIA A 8 15 2 4 0 0 0 0
NAUSEA A 23 44 4 8 0 0 0 0
STOMATITIS A 19 37 2 4 0 0 0 0
CONSTIPATION A 10 19 0 0 0 0 0 0
VOMITING A 8 15 1 2 0 0 0 0
DIARRHEA-NO COLOSTOM A 10 19 0 0 0 0 0 0
NECROSIS A 0 0 0 0 0 0 1 2
Oral cavity MS CE A 25 48 0 0 0 0 0 0
Hepatic SGOT (AST) A 8 15 0 0 0 0 0 0
HYPOALBUMINEMIA A 5 10 1 2 0 0 0 0
Infection/Febrile Neutropenia BRONCHITIS NOS A 1 2 0 0 0 0 1 2
Metabolic/Laboratory HYPERCHOLESTEROLEMI A 15 29 0 0 0 0 0 0
HYPOCALCEMIA A 6 12 0 0 0 0 0 0
HYPONATREMIA A 4 8 2 4 0 0 0 0
HYPOKALEMIA A 8 15 2 4 0 0 0 0
HYPERTRIGLYCERIDEMIA A 26 50 1 2 0 0 0 0
HYPERGLYCEMIA A 30 58 4 8 0 0 0 0
ALK PHOSPHATASE A 6 12 1 2 0 0 0 0
Neurology DEPRESSION A 2 4 0 0 0 0 1 2
Pain PAIN-BONE A 1 2 0 0 2 4 0 0
Pulmonary COUGH A 13 25 1 2 0 0 0 0
DYSPNEA A 11 21 5 10 1 2 0 0
Death DEATH NOS A 0 0 0 0 0 0 1 2
SUDDEN DEATH A 0 0 0 0 0 0 1 2
DISEASE PROGRESSION A 0 0 0 0 0 0 5 10
Surgery/Intra-Op Injury LUNG INJ A 0 0 0 0 1 2 0 0
Vascular VASC ACCESS COMPLIC A 0 0 1 2 1 2 0 0
LUNG NCCTG LUNG Committee N0323 - Page 4 of 5
NCCTG Status Report for Study N0323 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Maximum Grade Adverse Event A 18 35 21 40 1 2 11 21
LUNG NCCTG LUNG Committee N0323 - Page 5 of 5
NCCTG Status Report for Study N0426 - September 2007
A Phase II Study of Pemetrexed Disodium (ALIMTA) Plus Bevacizumab in
Patients with Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung
Cancer (Second-Line Treatment)
Purpose of 1) Primary - To assess the 3-month progression-free survival rate of the combi-
Study: nation of pemetrexed disodium with bevacizumab in patients with Stage
IIIB (pleural effusion) or IV NSCLC (second-line).
2) Secondary - To assess the time-to-event efficacy variables: overall survival
time and duration of response for responding patients; determine the tumor
response rate and toxicity profile.
3) Translational - To evaluate polymorphisms in pemetrexed target genes, and
intracellular content of pemetrexed polyglutamates.
Study Chairs: Alex A. Adjei M.D. QC Specialist: Paula J. Stellmaker
Donald B. Wender M.D.
Statistician: Sumithra J. Mandrekar Ph.D. Nurse Resource: Wanda L. DeKrey R.N.,
OCN
Status: 05/19/2006 Activated Projected Number of Patients: 46
02/23/2007 Perm. Closed
Excluded: None Final Accrual: 48
Stratification
Factors:
Schema: Register
Bevacizumab + Pemetrexed.
Treating Schedule:
Arm Agent Dose Route Days Freq
A ALIMTA * 500 mg/m2 IV in 100ml NS over 10 1 Every 21 days (+/- 7 days)
min. via an automatic dis-
pensing pump
A Bevacizumab 15 mg/kg IV infusion over 90 (+/- 1 Every 21 days (+/- 7 days)
15) minutes **
*Creatinine clearance must be >=45 mL/min before any ALIMTA is given
using the Cockcroft-Gault formula.
**If well-tolerated, second dose may be administered over 60 (+/- 10)
minutes. Again, well-tolerated, subsequent doses may be administered
over 30 (+/- 10) minutes.
LUNG NCCTG LUNG Committee N0426 - Page 1 of 4
NCCTG Status Report for Study N0426 - September 2007
Study Design: This phase II study is designed to assess the 3-month progression-free survival
rate of the combination of pemetrexed disodium and bevacizumab as second-line treatment
among patients with advanced NSCLC (Stage IIIB with pleural effusion or IV). The proportion
of progression-free patients at 3 months is our primary endpoint, which will be evaluated using
a one-stage Fleming design. This trial is planned as a one-stage design since at the rate of 6
patients per month, we would be very close to our final accrual before patients would become
evaluable for interim analysis. In addition, we do not expect this combination to be inferior to
the single agent of pemetrexed disodium alone, which is currently approved for treatment of
second-line NSCLC.
Accrual: This study enrolled 48 patients before permanently closing on February 23, 2007,
after having met the accrual objective.
Patient Characteristics: The distribution of patients at study entry is located in the Baseline
Characteristics Table.
Adverse Events: Adverse event data is available on 46 patients. Seven (15%) patients have
experienced grade 4/5 adverse events. One patient experienced grade 4 neutropenia (definitely
related) and grade 4 thrombosis (possibly); 1 patient experienced grade 4 thrombocytopenia,
grade 4 neutropenia, grade 4 lymphopenia, and grade 4 leukopenia, all considered definitely
related to study treatment; 1 patient experienced grade 4 fatigue (not related), grade 4 thrombo-
sis (possibly), and grade 4 dyspnea (possibly); 1 patient experienced grade 4 fatigue (probably)
and grade 4 dyspnea (unlikely); 1 patient experienced a grade 5 death NOS; and 2 patients have
experienced grade 5 disease progressions. See Adverse Events table for more details.
LUNG NCCTG LUNG Committee N0426 - Page 2 of 4
NCCTG Status Report for Study N0426 - September 2007
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Ann Arbor 5 0 4
Bismarck 3 0 3
Carle 2 0 2
Cedar Rapids 1 0 1
Dayton 1 0 1
Duluth 2 0 2
Hawaii CCOP 1 0 1
Heartland 1 0 1
Lehigh 3 0 3
MN CGOP 1 0 1
Metro MN 7 0 6
Montana 1 0 1
Peoria 4 0 4
Sioux City 3 0 2
Upstate Carol 2 0 2
Wichita 3 0 3
Total Membership Accrual 40 0 37
Randomizing Total Past 6 Past 12
Group Entered Months Months
NCCTG 40 0 37
SWOG 8 0 8
Total Group Accrual 48 0 45
Baseline Characteristics Table:
Arm
Characteristics
A
Clinical Stage
IIIB w/pleural effusion 2
IV 44
Gender
f 14
m 34
Performance Score
0 17
1 24
2 5
LUNG NCCTG LUNG Committee N0426 - Page 3 of 4
NCCTG Status Report for Study N0426 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 46
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 18 39 7 15 2 4 0 0
LEUKOPENIA A 24 52 6 13 1 2 0 0
ANEMIA A 36 78 0 0 0 0 0 0
LYMPHOPENIA A 1 2 5 11 1 2 0 0
THROMBOCYTOPENIA A 22 48 0 0 1 2 0 0
Cardiovascular THROMBOSIS A 0 0 3 7 2 4 0 0
HYPERTENSION A 9 20 3 7 0 0 0 0
Constitutional Symptoms FATIGUE A 11 24 4 9 2 4 0 0
Dermatology/Skin RASH A 17 37 0 0 0 0 0 0
Gastrointestinal ANOREXIA A 5 11 1 2 0 0 0 0
NAUSEA A 24 52 0 0 0 0 0 0
STOMATITIS A 10 22 0 0 0 0 0 0
VOMITING A 9 20 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 14 30 1 2 0 0 0 0
Oral cavity MS CE A 10 22 0 0 0 0 0 0
Hemorrhage BRONCHUS HEMORR A 7 15 0 0 0 0 0 0
Metabolic/Laboratory HYPERGLYCEMIA A 4 9 2 4 0 0 0 0
Pulmonary DYSPNEA A 6 13 2 4 2 4 0 0
Renal /Genitourinary PROTEINURIA A 5 11 0 0 0 0 0 0
Death DEATH NOS A 0 0 0 0 0 0 1 2
DISEASE PROGRESSION A 0 0 0 0 0 0 2 4
Maximum Grade Adverse Event A 16 35 22 48 4 9 3 7
LUNG NCCTG LUNG Committee N0426 - Page 4 of 4
NCCTG Status Report for Study E1B03 - September 2007
Pemetrexed Plus Gemcitabine or Carboplatin in Patients with Advanced
Malignant Mesothelioma: A Randomized Phase II Trial
Purpose of 1) The primary objective of this study is to estimate the response rates in
Study: patients with pleural mesothelioma when treated with either carboplatin plus
pemetrexed or gemcitabine plus pemetrexed.
2) The secondary objectives of this study are to assess the relative toxicities of
each regimen and estimate survival time.
3) Exploratory analysis evaluating incidence and prognostic implications of
SV40 DNA sequences. To assess the presence of SV40 antigen in tumor
samples and to determine if possible CD8+ T lymphocyte responses have
been triggered in patients with SV40 positive tumors.
Study Chairs: Scott Okuno M.D. QC Specialist:
Eliot L. Friedman M.D.
Statistician: Nurse Resource:
Status: 12/09/2005 Activated Projected Number of Patients: 66
Stratification None
Schema: Randomize
Arm A: Dexamethasone, Pemetrexed, Carboplatin
Arm B: Dexamethasone, Pemetrexed, Gemcitabine
NCCTG Status Report for Study N0623 - September 2007
Phase II Study of GW786034 in Patients with Malignant Pleural Mesothelioma
Purpose of - Primary
Study: 1) To evaluate the effect of GW786034 on the proportion of patients with
MPM who are progression-free at 6 months based on the RECIST criteria.
2) To describe the clinical toxicities of GW786034 in this patient population.
- Secondary
1) To assess agreement in the objective tumor response status as measured by
the RECIST and the modified RECIST criteria specific to MPM.
2) To evaluate the response rate of GW786034 in patients with MPM based on
the RECIST and the modified RECIST criteria for MPM.
3) To evaluate the effect of GW786034 on overall survival and time to progres-
sion (based on RECIST and the modified RECIST criteria for MPM).
4) To evaluate predictive markers of activity of GW 786034.
5) To evaluate serologic markers of target inhibition by GW786034.
6) As part of ongoing research for NCCTG lung studies, we are banking paraf-
fin-embedded tissue block/slides and blood samples for future histochemis-
try evaluation and DNA extraction.
Study Chairs: Julian R. Molina M.D. QC Specialist: Jennifer P Schreiber
Nicholas F. Reuter M.D.
Statistician: Sumithra J. Mandrekar Ph.D. Nurse Resource: Wanda L. DeKrey R.N.,
OCN
Status: 03/23/2007 Activated Projected Number of Patients: 55
Excluded: None Final Accrual: NA
Stratification None
Schema: Reg
GW786034
Treating Schedule:
Arm Agent Dose Route Days Freq
pazopanib 800 mg* Oral Daily** Every 3 weeks***
*Two 400 mg tablets. While in an upright position, the patient should
swallow the tablets approximately 1 cup (240 mL) of water. Pazopanib
should be taken at approximately the same time each morning, either 1
hour before or 2 hours after eating. The tablets must not be chewed,
crushed, or broken.
**Treatment continues every day for a maximum of 2 years from
registration or until disease progression, unacceptable toxicity,
LUNG NCCTG LUNG Committee N0623 - Page 1 of 2
NCCTG Status Report for Study N0623 - September 2007
patient refusal, investigator decision to remove patient, or
alternative treatment.
***Cycle length = 3 weeks.
Study Design: The primary goal of this phase II study is to evaluate the efficacy and biological
effects of pazopanib treatment in patients with malignant pleural mesothelioma (MPM). The
primary endpoint of this study is the proportion of progression-free patients at 6 months based
on the RECIST criteria. Based on a single-stage 3-outcome design, the treatment will be consid-
ered effective, ineffective or inconclusive if at least 30 successes, at most 28 successes, or 29
successes are observed in the 50 evaluable patients respectively.
Accrual: This study has enrolled one patient as of August 6, 2007.
Adverse Events: Adverse event data is available for the one enrolled patient. This patient expe-
rienced the following adverse events: grade 1 hypertension, grade 1 diarrhea-no colostom, grade
1 vomiting, grade 2 fatigue, grade 2 nausea, grade 2 weight loss, grade 2 dehydration, grade 2
proteinuria, and grade 3 anorexia. The Adverse Event Table is not included since all adverse
events reported are summarized above.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Green Bay 1 1 1
Total Membership Accrual 1 1 1
LUNG NCCTG LUNG Committee N0623 - Page 2 of 2
NCCTG Status Report for Study BR.19 - September 2007
A Phase III Prospective Randomized, Double-Blind, Placebo Controlled Trial
of the Epidermal Growth Factor Receptor Antagonist, ZD1839 in Completely
Resected Stage IB, II and IIIA Non-Small Cell Lung Cancer
Purpose of 1) To compare whether adjuvant treatment with ZD1839 (IRESSA) is superior
Study: to placebo in patients with completely resected stage IB, II and IIIA non-
small cell lung cancer in terms of: overall survival and disease-free sur-
vival.
2) To confirm the prognostic significance and to assess the predictive ability of
EGFR expression, phosphorylation and mutations and the likelihood of
“response” to ZD1839 (IRESSA) in terms of overall survival. A compre-
hensive tumour bank will be established and linked to the clinical database
for the further study of molecular markes in non-small cell lung cancer.
Study Chairs: G. Goss NCCTG Study
T. Winton Chair: J. Jett
H. Choy
J. Jett
F. Khuri
G. Masters
P. Roberts
I. Lorimer
M. Sound Tsao
F. Shepherd
Status: 09/13/2002 Activated Projected Number of Patients: 1242
04/22/2005 Perm. Closed
Schema: Randomize
Arm 1 ZD1839
Arm 2 Placebo
This is an NCIC coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study S9925 - September 2007
Lung Cancer Specimen Repository Protocol, Ancillary
Purpose of 1) To establish a central lung cancer specimen repository to serve as a resource
Study: for current and future scientific studies.
2) To utilize the Southwest Oncology Group clinical data base to perform clini-
copathologic correlation with the results of those studies.
3) To test new hypotheses as they emerge.
Study Chairs: D. Gandara NCCTG Study
W. Franklin Chair: R. S. Marks
P. Gumerlock
Status: 9/1/2000 Activated Projected Number of Patients:
Schema:
This is a SWOG coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Other Closed LUNG Trials - September 2007
952053 * A Pilot Study of High-Dose Thoracic Radiation Therapy With Concomi-
tantCisplatin/Etoposide in Limited-Stage Small Cell Lung Cancer
* Closed: 03/12/1999
* Final accrual data appeared in the 1999 NCCTG book
* Final toxicity data appeared in the 1999 NCCTG book
* ASCO abstract appeared in the 1999 NCCTG book
* Manuscript Status: Published
'Results of a Phase II Study of High-Dose Thoracic Radiation Therapy
with Concurrent Cisplatin and Etoposide in Limited-Stage Small-Cell
Lung Cancer' Steven E. Schild, James A. Bonner, Shauna Hillman, et.al
JCO Jul 20 2007: 3124-3129
972451 * Phase III Randomized, Double-Blind Study of CAI and Placebo inPatients
With Advanced Non-Small Cell Lung Cancer (NSCLC)
* Closed: 08/11/2004
* Johnson EA, Marks RS, Mandrekar SJ, Hillman SL, Hauge MD, Bauman
MD, Wos EJ, Moore DF, Kugler JW, Windschitl HE, Graham DL,
Bernath AM Jr, Fitch TR, Soori GS, Jett JR, Adjei AA, Perez EA; Phase III
Randomized, Double-Blind Study of Maintenance CAI or Placebo in
Patients with Advanced Non-Small Cell Lung Cancer After Completion of
Initial Therapy (NCCTG 97-24-51); submitted to Lung Cancer.
N0021 * Phase II Study of Gemcitabine and Epirubicin for the Treatment ofMesothe-
lioma
* Closed: 04/09/2004
* The final Accrual and Toxicity Tables appeared in the Fall 2005 NCCTG
Meeting Book.
* Abstracts: An ASCO abstract was submitted to the 2003 ASCO meetings
on the data from the 23 patients treated at the original starting dose
(see the April 2003 NCCTG Book to see a copy of the abstract). An
ASCO abstract was also submitted to the 2005 ASCO meetings on the data
from the last 46 patients who were treated at the reduced dose.
* Manuscript Status: Submitted to Cancer.
N0027 * Phase II Trial of Oral Topotecan and Intravenous Carboplatin withG-CSF
(Filgastim) Support in Previously Untreated Patients with Extensive Stage
Small Cell Lung Cancer
* Closed: 01/07/2003
* Final accrual/toxicity data appeared in the Fall 2004 NCCTG Book
* Manuscript status: In progress
LUNG NCCTG LUNG Committee Other Closed Trials - Page 1 of 2
NCCTG Status Report for Other Closed LUNG Trials - September 2007
N0222 * Parallel Phase II Trials of ZD1839 (Iressa) Alone or WeeklyCarboplatin and
Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for
Metastatic Non-Small Cell Lung Cancer in Patients >=65 Years of Age
* Closed: 02/24/2006
* Final accrual/toxicity data appeared in the Fall 2006 NCCTG Book
* Manuscript status: In progress
N0326 * Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in PatientsWith
Advanced Non-Small Cell Lung Cancer
* Closed: 08/04/2006
* Final accrual/toxicity appeared in the Fall 2006 NCCTG Book
* Patient outcome data was presented as a poster at ASCO 2007
* Manuscript status: In progress
LUNG NCCTG LUNG Committee Other Closed Trials - Page 2 of 2
Protocol Concepts for LUNG - September 2007
N0621 Phase II Study of the c-SRC Inhibitor, AZD0530, After Four Cycles ofCy-
toreductive Chemotherapy for Patients With Extensive Stage SmallCell
Carcinoma
Purpose of - Treatment
Study: 1) Primary goal is to determine the 12-week progression-free survival rate of
AZD0530 for patients with extensive stage small cell lung cancer.
2) Secondary goals consist of determining the response rate, overall survival,
time-to-progression, and adverse event rate in this patient population.
- Translational Research
1) As part of ongoing research for NCCTG lung studies, we are banking paraf-
fin-embedded tissue blocks/slides for future histochemistry evaluation and
DNA extraction.
Schema: Pre-Registration
Four 3-week cycles of standard platinum-based chemotherapy regimen
Registration
AZD0530
*****************************************************************************
N0626 A Phase II Randomized Study of Pemetrexed Combined With Sorafenib-
Versus Pemetrexed Alone as Second-line Therapy in Patients WithAd-
vanced Non-Small Cell Lung Cancer
Purpose of - Primary
Study: 1) To compare the progression-free survival in patients who receive pemetr-
exed and sorafenib (experimental) versus pemetrexed alone (standard) in
patients with advanced non-small cell lung cancer (second-line).
- Secondary endpoints
1) To compare the overall survival, tumor response rate, duration of response,
and toxicity rates between pemetrexed and sorafenib (experimental) versus
pemetrexed alone (standard) in patients with advanced non-small cell lung
cancer (second line).
- Translational
1) To evaluate the intracellular content of pemetrexed polyglutamates as a mea-
sure of activity of pemetrexed transport and activation enzymes.
2) To evaluate polymorphisms and gene expression in pemetrexed patients.
3) To evaluate predictive markers of hypertension (e.g. pharmacogenetics,
VEGF-A and sVEGFR-1, and ADMA) in relation to clinical toxicity and
outcomes.
LUNG NCCTG LUNG Committee Protocol Concepts - Page 1 of 3
Protocol Concepts for LUNG - September 2007
4) As part of ongoing research for NCCTG lung studies, we are banking paraf-
fin-embedded tissue blocks/slides and blood samples for future evaluation of
pharmacogenetic and/or proteomic markers.
Schema: Randomize
Pemetrexed + Sorafenib
Pemetrexed
*****************************************************************************
N0723 A Phase III Biomarker Validation Study of Second-Line Therapy inPa-
tients With Advanced Non-Small Cell Lung Cancer (NSCLC) Random-
izedto Pemetrexed Versus Erlotinib
Purpose of 1) To evaluate whether there are differences in progression-free survival due to
Study: treatment with erlotinib compared to pemetrexed for subsets of previously
treated NSCLC patients defined by epidermal growth factor receptor
(EGFR)-FISH positivity versus negativity.
2) To ascertain the presence or absence of true differences due to treatment in
the objective clinical endpoints of overall survival, confirmed response rate,
and adverse event profile for subsets of patients defined on the basis of the
EGFR-FISH positivity versus negativity.
3) To ascertain the presence or absence of true differences due to treatment in
objective clinical endpoints for subsets of patients defined on the basis of
EGFR expression as measured by immunohistochemistry (IHC).
4) To ascertain the presence or absence of true differences due to treatment in
objective clinical endpoints for subsets of patients defined on the basis of the
EGFR gene mutation status (MUT).
5) To evaluate the prognostic effect of EGFR copy number as measured by
FISH, EGFR expression as measured by IHC, and EGFR mutation status.
6) To prospectively test the hypothesis that functionally relevant polymor-
phisms in the genes encoding for pemetrexed targests and in the EGFR
gene, either singly or in combination, play a role in the efficacy and/or toxic-
ity of erlotinib.
7) To evaluate proteomic signatures in blood samples of patients as predictors
of response and survival to treatment with erlotinib.
8) To evalute the following variables measured in tumor samples, as predictors
of response and survival: expression of thymidylate synthase, dihydrofolate
reductase and GAR formyltransferase genes by quantitative PCR, as well as
methylthioadenosine phosphorylase expression by IHC.
9) To evaluate the following variables measured in tumor samples, as predic-
tors of response and survival: Ras mutational status, EGFR mutational sta-
tus, and epithelial to mesenchymal transition (EMT) status (measured by E-
cadherin expression and vimentin expression by
LUNG NCCTG LUNG Committee Protocol Concepts - Page 2 of 3
Protocol Concepts for LUNG - September 2007
Schema: Pre-Registration
Central Pathology review and EGFR gene copy number measured by FISH
Randomization
Erlotinib (150mg daily)
Pemetrexed (500mg IV day 1)
*****************************************************************************
N0724 A Phase II Study of the Treatment of Oligometastatic Stage IVNon-Small
Cell Lung Cancer (NSCLC) with Systemic Therapy plusRadiotherapy to
all Sites of Gross Disease
Purpose of - Primary Goal
Study: 1) To assess whether the addition of radiation therapy after an initial course of
standard chemotherapy results in an improvement in 1-year survival in all
eligible Stage IV NSCLC patients.
- Secondary Goals
1) To assess the 1-year survival in eligible patients that receive radiation ther-
apy.
2) To estimate the overall survival, time-to-disease progression, time-to-treat-
ment failure, confirmed response rate, duration of response, adverse events,
and quality of life in the entire cohort, and in selected patient subgroups of
interest.
Schema: Registration
Systemic Therapy
Radiation
LUNG NCCTG LUNG Committee Protocol Concepts - Page 3 of 3
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Neuro-Oncology Program
The goals of the Neuro-oncology Committee are: 1) to improve duration and quality of life of
brain tumor patients; 2) to assess disease and treatment-related effects on neurocognitive
function and quality of life (QOL), while developing interventions for such effects; and 3) to
identify prognostic and predictive variables that correlate with outcome, and improve our
methods of conduct of clinical trials.
For newly diagnosed glioblastoma, NCCTG has activated RTOG 0525, a randomized Phase III
trial of concomitant RT+TMZ followed by randomization to standard vs. dose-dense TMZ; this
trial is setting records for accrual within RTOG, N027D, involving the addition of RAD-001 to
standard RT+TMZ, is under repeat review at CTEP. The Phase III intergroup study N0574 is
open for newly diagnosed brain metastases, randomizing patients with 1-3 lesions to stereotactic
radiosurgery (SRS) vs. whole brain RT + SRS. NCCTG is nearing final submission of a revised
Phase III intergroup study for 1p/19q co-deleted newly diagnosed anaplastic glioma patients, and
is awaiting approval for an intergroup study led by EORTC (26053) for undeleted newly
diagnosed anaplastic gliomas. A Phase III intergroup study for newly diagnosed low grade
glioma patients has been approved by CTEP and will open soon (ECOG E3F05). A new trial for
primary CNS lymphoma (ECOG E1F05) will open to group very soon, and several new trials for
recurrent glioblastoma are on the way.
Cancer Treatment Trials:
Glioblastoma (grade 4 astrocytoma):
NCCTG activated RTOG 0525, a Phase III study for patients with newly diagnosed
GBM. Patients undergoing partial or gross total resection (stereotactic biopsy only pts
are ineligible), who have adequate tissue (per RTOG central review) for MGMT analysis
(determined centrally prior to randomization) will be eligible. All patients will receive
RT + concomitant TMZ but will be randomized for the adjuvant component to either
conventional 5 day/every 28 day TMZ or ‘dose-dense’ TMZ 21 days/every 28 days.
EORTC and NCIC are also participating in this study. Patients will be stratified by RPA
class and MGMT gene promoter hypermethylation status. This study is accruing very
rapidly, and recent amendments add a neurocognitive / QOL battery of tests and have
increased the target accrual to over 1100 patients.
N027D “A Phase I Study of temsirolimus (CCI-779), Temozolomide, and Radiation in
Newly Diagnosed Glioblastoma Multiforme” builds on prior promising data in recurrent
glioma (N997B) with temsirolimus. This trial is open at Mayo clinic, and a decision
regarding any additional Phase II component will follow completion of the Phase I.
N057K: “FDG PET evaluation of RAD001 sensitivity in a phase I evaluation of
radiation and temozolomide followed by adjuvant temozolomide and RAD001 in newly
diagnosed glioblastoma” is a protocol that has been submitted to CTEP. Review
comments have been addressed and the protocol is at CTEP for final review. A Phase II
study will potentially follow pending results of the Phase I.
N0177, "Pilot and Phase II Trial of OSI-774 and Radiation in Glioblastoma Multiforme
Patients” completed accrual and analysis of the mature data is imminent.
One additional trial for newly diagnosed GBM is being developed as a potential
intergroup study with NABTC/NABTT.
Anaplastic Astrocytoma (grade 3 astrocytoma)
A trial for patients with anaplastic gliomas that are not co-deleted for 1p and 19q has
been activated by the EORTC (EORTC 26053), and NCCTG will participate in this
intergroup effort, which also includes ECOG, NCIC, and RTOG, who will lead the study.
The study is a 2 by 2 design, with patients initially randomized to either RT vs RT+
concomitant TMZ; and further randomization to receive or not receive adjuvant TMZ
(conventional 5 day/Q 28 day dosing). The study is powered to answer 1) whether there
is a survival advantage with the addition of concomitant TMZ to RT and 2) whether there
is a survival advantage with the addition of adjuvant TMZ.
Anaplastic Oligodendroglioma and Oligoastrocytoma.
A final design for N0577 has been generated after considerable discussions between the
cooperative groups. This will be a Phase III Intergroup study for patients with anaplastic
oligodendroglioma and mixed glioma who have detectable tumor 1p and 19q co-deletions
RTOG, ECOG, NCIC and EORTC have indicated willingness to participate in this study,
which will also be listed on the CTSU. The design will be discussed at the meeting.
Low Grade Glioma:
NCCTG has agreed to participate in a Phase III ECOG study for newly diagnosed high
risk low-grade glioma patients (E3F05). The design will be RT vs RT+TMZ. This
recently received approval from CTEP and CIRB pending minor revisions.
Newly Diagnosed Primary CNS Lymphoma:
NCCTG has sent a letter of commitment to participate in an intergroup Phase II ECOG
study (E1F05), which will evaluate the combination of rituximab and combination
chemotherapy. This study should be activated very soon.
Recurrent Glioblastoma and Grade 3 Anaplastic Astrocytoma:
NCCTG N047B, “Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA) in
Treatment of Recurrent Glioblastoma”, is still open for 1) patients who have received
more than 2 prior therapies for recurrence or 2) who are undergoing re-resection for
clinical reasons, but has completed accrual for the Phase II decision rule patients. This
was a positive study, presented at ASCO 2007 and further study on vorinostat in targeted
combinations is planned in the upcoming N0776.
NCCTG N0572 The Phase I component of “Phase I/II Trial of Sorafenib and CCI-779 in
Recurrent Malignant Astrocytoma” has been modified to add an intermediate dose
schedule, due to toxicities observed in the initial cohorts. An amendment has been
processed to evaluate a final cohort, and if the new combination is tolerated in this
cohort, the phase II study will open. Initial Phase I data will be presented at the SNO
meeting this Fall.
NCCTG N0776 is a Phase II trial of vorinostat and bortezumib for recurrent GBM.
Revisions to the CTEP review have been sent to CTEP for final approval.
Three additional new trials for recurrent GBM, involving targeted combinations with
bevacizumab, have also been submitted.
Recurrent Oligodendroglioma and Mixed Oligoastrocytoma: N0272, "Phase II Trial of
Imatinib Mesylate; (Gleevec; STI571) In Treatment of Recurrent Oligodendroglioma and
Mixed Oligoastrocytoma" continues to accrue. The Phase II is open for patients not
receiving EIACs, and the Phase I re-opened for patients receiving EIACs to gain
additional data. The group is reminded that this study is open for patients who have failed
multiple (i.e., > 2) regimens for recurrence, and also for low grade oligos with recurrence
as well as anaplastic oligos. Initial PK results will be presented at the SNO meeting this
Fall.
CNS Metastases: NCCTG N0574, “A Phase III Randomized Trial of the Role of Whole Brain
Radiation Therapy in Addition to Radiosurgery in the Management of Patients with One
to Three Cerebral Metastases”, is open. This is a Phase III randomized trial of stereotactic
radiosurgery (SRS) versus SRS + whole brain radiotherapy for patients with 1-3 CNS
metastases. The primary endpoint is overall survival, and the trial also contains QOL and
neurocognitive correlative endpoints.
NCCTG N073Y, “Phase II trial of lapatinib and bevacizumab in patients with HER2
positive breast cancer with brain metastases” is a new trial in processing.
Neurobehavioral / QOL Studies
An interventional study for depression in brain tumor patients is in development.
Translational Studies
Translational correlative studies accompany nearly all of the recent and active treatment
protocols, including NCCTG N0177, N0272, N997B, N0577, N027D, N0572, N0574,
N047B, N057K, E3F05, and R0525. Many of the new trials include tissue analyses for
prognostic factors, and even assignment of protocol based on markers at baseline.
Patients eligible for N0577 and EORTC 26053 will have determinations of 1p/19q status
prior to study treatment. Methylguanine methyltransferance (MGMT) gene promoter
hypermethylation status in tumor tissue will be used as a stratification factor for RTOG
0525, and is also included in N0272, N0577, EORTC 26503, E3F05 and others.
Quality of life and neurocognitive correlative investigations accompany many of our
trials, including N0272, N997B, N0577, N0574, E3F05, and R0525.
The group members are again to be congratulated on a superb job of acquiring and
mailing of tissue and blood specimens obtained from patients on our trials who have
provided consent for the translational tissue correlative analyses. Many of these
correlative studies provide the scientific rationale for design of our clinical trials, and
support the overall goals of the Neuro-oncology committee. We recognize that this
component takes time from busy practices, and the NCCTG is very appreciative of your
efforts.
Database Studies.
N047D “Relationship between Phase II Endpoints of 12 Month Overall Survival and 6
Month Progression-free Survival for GBM Phase II trials” compared different potential
outcome endpoints for determination of treatment efficacy in our clinical trials, and found
that progression free survival at 6 months (PFS6) correlated reasonably with a survival
endpoint (OS12), confirming its usefulness as the primary endpoint in our recurrent
disease trials. 94-72-53, "Diagnostic and Prognostic Markers in Low-Grade Gliomas" and
94-72-52, "Diagnostic and Prognostic Markers in Anaplastic Astrocytoma and Anaplastic
Oligoastrocytoma" continues to mature and data has been the subject of several abstracts
and manuscripts. NCCTG N0475, “Association Between Endpoints and Baseline
Anticonvulsant Status for Newly Diagnosed GBMs” found that patients receiving EIAC
at baseline in three of our up-front GBM studies paradoxically correlated with longer
survivals. A recent cooperative effort between NCCTG and UCSF has evaluated
prognostic variables in Recurrent GBM trials. This data was presented in part at ASCO
and will be reviewed at SNO this Fall.
NCCTG Neuro-Oncology Program Manuscripts and Accepted Abstracts:
Manuscripts Published or Accepted in 2006-2007
937252: Marshall, Nicole E. M.D.; Ballman, Karla Ph.D.; Michalak, John C. M.D.;
Schomberg, Paula J. M.D.; Burton, Gary V. M.D.; Sandler, Howard M. M.D.; Cascino,
Terrence L. M.D.; Jaeckle, Kurt J. M.D.; Buckner, Jan C. M.D., Ototoxicity of Cisplatin
Plus Standard Radiation Therapy Versus Accelerated Radiation Therapy in
Glioblastoma Patients, J Neuro Oncol , J Neurooncol. 2006 May; 77 (3):315-20.
98-71-51/98-72-52/N0074: Brown PD, Ballman KV, Rummans TA, Maurer MJ, Sloan
JA, Boeve BF, Gupta L, Tang-Wai DF, Arusell RM, Clark MM, Buckner JC:
Prospective study of quality of life in adults with newly diagnosed high-grade gliomas. J
Neurooncol. 2006 Feb;76(3):283-91.
86-72-51: Brown, Paul D. M.D.; Petersen, Ivy A. M.D.; Schomberg, Paula J. M.D.;
Ivnik, Robert J.; Furth, Alfred F.; Ballman, Karla V. Ph.D.; Hammack, Julie E. M.D.;
Buckner, Jan C. M.D.; Shaw, Edward G. M.D.; Arusell, Robert M. M.D., Cognitive
function after radiotherapy for supratentorial low-grade glioma: A North Central Cancer
Treatment Group, Int J Radiat Oncol Biol Phys 58(4):1153-1160, 2005
N007D: Galanis, Evanthia M.D.; Buckner, Jan C M.D.; Maurer, Matthew J.; Sykora, R;
Castillo, Rene A. M.D.; Ballman, Karla V. Ph.D.; Erickson, Bradley J. M.D., Validation
of neuroradiologic response assessment in gliomas: RECIST (lD) vs 2D measurements
vs. computer assisted tumor area vs. volume. N007D is revised and under review by
Neuro-Oncology 8:156-65, 2006.
R94-02: Cairncross, Gregory M.D.; Berkey, B; Shaw, Edward G. M.D.; Jenkins, Robert
B. M.D.; Scheithauer, Bernd W. M.D.; Brachman, D; Buckner, Jan C M.D.; Fink,
Karen; Souhami, Luis; Laperierre, Normand; Mehta, Minesh P. M.D.; Curran, Walter
M.D., Phase III Trial of Chemotherapy plus Radiotherapy compared with radiotherapy
alone for Pure and Mixed Anaplastic Oligodendroglioma: Intergroup Radiation Therapy
Oncology Group Trial 9402. J Clin Oncol: 24:2707-2722, 2006
93-72-52: Buckner JC, Ballman KV, Michalak JC, Burton GV, Cascino TL, Schomberg
PJ, Hawkins RB, Scheithauer BW, Sandler HM, Marks RS, O'Fallon JR; North Central
Cancer Treatment Group 93-72-52; Southwest Oncology Group 9503 Trials.Phase III
trial of carmustine and cisplatin compared with carmustine alone and standard radiation
therapy or accelerated radiation therapy in patients with glioblastoma multiforme: North
Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 Trials. J
Clin Oncol. 2006 Aug 20;24 (24):3871-9
N0177: S. Krishnan, P. D. Brown, K. V. Ballman, J. B. Fiveash, J. H. Uhm, C. Giannini,
K. A. Jaeckle, F. J. Geoffroy, L. B. Nabors, J. C. Buckner; North Central Cancer
Treatment Group. Phase 1 trial of erlotinib with radiation therapy (RT) in patients with
glioblastoma multiforme (GBM): Results of North Central Cancer Treatment Group
Protocol N0177. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1192-9.
96-73-51: Laack, Nadia N. M.D.; Ballman, Karla Ph.D.; O'Neill, Brian P. M.D.; Brown,
Paul D. M.D., Whole-brain radiotherapy (WBRT) and high-dose methylprednisolone
(HDMP) for elderly patients with Primary Central Nervous System Lymphoma
(PCNSL): Results of North Central Cancer Treatment Group (NCCTG) 96-73-51, Int J
Radiat Oncol Biol Phys, 2006
94-72-53: Jenkins RB, Blair H, Ballman KV, Giannini C, Arusell RM, Law M, Flynn H,
Passe S, Felten S, Brown PD, Shaw EG, Buckner JC : A t(1;19)(q10;p10) mediates the
combined deletions of 1p and 19q and predicts a better prognosis of patients with
oligodendroglioma. Cancer Res. 2006 Oct 15;66(20):9852-61
N0047D: Ballman KV, Buckner JC, Brown PD, Giannini C, Flynn PJ, LaPlant BR,
Jaeckle KA: The relationship between six-month progression-free survival and 12-month
overall survival end points for phase II trials in patients with glioblastoma multiforme.
Neuro-oncol. 2007 Jan;9 (1):29-38
94-72-52: Buckner JC, O'Fallon JR, Dinapoli RP, Schomberg PJ, Farr G, Schaefer P,
Giannini C, Scheithauer BW, Ballman KV: Prognosis in patients with anaplastic
oligoastrocytoma is associated with histologic grade. J Neurooncol. 2007 Sep;84(3):279-
86.
2006-2007 Abstracts:
94-72-53: Jenkins, Robert B. M.D.; Ballman, Karla V. Ph.D.; Giannini, Caterina M.D.;
Arusell, Robert M. M.D.; Blair, H E; Flynn, H; Passe, Sandra; Brown, Paul D. M.D.;
Shaw, Edward G. M.D.; Buckner, Jan C M.D., NCCTG 94-72-53: Diagnostic and
prognostic significance of a t(1:19)(q10:p10) patients (pts) with low-grade
oligodendroglioma and astrocytoma, Proc Am Soc Clin Oncol 24:18S , 59S, 2006.
94-94-52: Jaeckle KA., Decker PA., Ballman KV., Flynn PJ., Giannini C., Scheithauer
BW., Jenkins RB., Buckner JC.; Analysis of paired glioma tissues from initial diagnosis
and recurrence in patients enrolled on NCCTG clinical trials: de-differentiation and
association with survival. Proc Am Soc Clin Oncol 24:18S (I), 63S (Abstr 1521), 2006.
N997D: Ballman KV, Jaeckle KA, Schomberg P, Giannini C, Scheithauer B, Galanis E,
Uhm J, Brown P, Arusell R, Ames MM, Reid JM, Hammack JE, Buckner JC: .Phase II
trial of irinotecan (CPT-11) and radiation followed by irinotecan and BCNU in
glioblastoma patients (pts). Proc Am Soc Clin Oncol 24:18S (I), 73S (abstr 1562), 2006.
96-94-53: Buckner JC, Ballman KV., Schaefer P. Furth AF, Giannini C, Scheithauer
BW, Galanis E Jaeckle KA ;NCCTG 96-94-53: Clinical Variables Associated with
Overall Survival (OS), Progression-Free Survival (PFS), 6 month Progression-Free
Survival (PFS6), Immediate Progression (ImmProg), and Response in Patients (pts)
Enrolled in Recurrent Glioma Clinical Trials (ASCO 2006)
86-72-51: Daniels T, Brown, P et al: Validation of EORTC Prognostic Factors for Adults
with Low Grade Glioma: a Report Utilizing Intergroup 86-72-51. (ASTRO 2006)
94-94-52: Jaeckle KA, Ballman KV, Decker PA, Giannini C, Scheithauer B, Buckner JC;
Clinical prognostic factors in long-term survivors from a database of 1651 patients with
newly diagnosed glioblastoma (GBM) treated on prospective North Central Cancer
Treatment Group (NCCTG) clinical trials. (Society for Neurooncology, 2006)
N057N: Jaeckle KA, Furth AF, Wu W, Ballman KV, Flynn PJ, Brown PD, Galanis E,
Buckner JC: Comparison of Outcome of Patients with Newly Diagnosed and Recurrent
Gliomas treated on North Central Cancer Treatment Group (NCCTG) Phase II and III
trials within the Community as compared to an Academic Medical Center. (Society for
Neurooncology, 2006)
94-94-52: Jaeckle KA, Decker PA, Ballman KV, Flynn PJ, Giannini C, Scheithauer BW,
Jenkins RB, Buckner JC;Progressive Anaplastic Transformation of Infiltrative Gliomas:
A Correlative Clinicopathologic Study of Primary and Recurrent Tumors from Patients
Treated on North Central Cancer Treatment Group (NCCTG) Trials . (Society for
Neurooncology, 2006)
N0076: Paul D. Brown, Ashley Jensen, Sara J. Felten, , Karla V. Ballman, , Paul L.
Schaefer, Kurt A. Jaeckle, Jan C. Buckner: Cognitive function in patients with high-
grade glioma. . (Society for Neurooncology, 2006)
96-94-53: Lamborn K, Wu W, Prados M, Jaeckle H, Chang S, Novotny P, Buckner J:
Joint NABTC + NCCTG Prognostic Factors Analysis for High Grade Recurrent Glioma.
(ASCO, 2007)
N047B: E. Galanis, K. A. Jaeckle, M. J. Maurer, J. M. Reid, M. M. Ames, C. Giannini,
J. S. Hardwick, D. F. Moore, J. A. Zwiebel, J. C. Buckner: N047B: NCCTG phase II trial
of vorinostat (suberoylanilide hydroxamic acid) in recurrent glioblastoma multiforme
(GBM).Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I.
Vol 25, No. 18S (June 20 Supplement), 2007: 2004
N047B: Jaeckle KA, Maurer MJ, Reid JM, Ames MM, Giannini C, Moore DF, Richon
V, Fantin V, Reilly J, Loboda A, Hardwick J, Zwiebel JA, Buckner JC, Galanis E:
Results of a Phase II Trial of Vorinostat in Patients with Recurrent Glioblastoma:
Evidence of Post-Treatment Histone Acetylation in Tumor Tissue and Pharmacokinetic
Analysis: North Central Cancer Treatment Group (NCCTG) Study N047B. (6th Annual
International Conference on Targeted Therapy, 2007)
N0572: Schiff D, Sarkaria J, Decker P, Buckner J, Galanis E, Dancey J, Giannini C,
Brown P, Wiesenfeld M, Jaeckle K: Phase I study of Temsirolimus (CCI-779) and
Sorafenib in recurrent glioblastoma: North Central Cancer Treatment Group (NCCTG)
N0572. (Society for Neuro-oncology, 2007)
96-94-53: Wu W, Lamborn K, Buckner J, Jaeckle K, Chang S, Novotny P, Prados M:
Joint NCCTG and NABTC Prognostic Factors Analysis for High Grade Recurrent
Glioma (Society for Neuro-oncology, 2007)
N0272: Jaeckle KA, Anderson K, Wu W, Egorin M, Galanis E, Brown PD, Sarkaria J,
Colesas, D, Buckner J Pharmacokinetic Analysis of Imatinib in Patients with Recurrent
Anaplastic Oligodendroglioma: North Central Cancer Treatment Group (NCCTG)
N0272. (Society for Neuro-oncology, 2007)
Program Status Reports for NEURO-ONCOLOGY - September 2007
Neuro-Oncology
0525 Phase III Trial Comparing Conventional Adjuvant Temozolomide with-
Dose-Intensive Temozolomide in Patients with Newly DiagnosedGlio-
blastoma
947252 Diagnostic and Prognostic Markers in High-Grade Glioma
947253 Diagnostic and Prognostic Markers in Low-Grade Glioma
949452 Clinical Significance of Histologic Typing of High-Grade Glioma
969453 Factors Associated With, Response, Time to Progression and Overall-
Survival in Recurrent Glioma Phase II Trials
98-13 A Phase III (Phase I Closed) Randomized Study of Radiation Therapy
andTemozolomide (IND #60,265) Versus Radiation Therapy and
Nitrosoureafor Anaplastic Astrocytoma and Mixed Anaplastic Oligoas-
trocytoma(Astrocytoma Dominant)
N0177 A Pilot and Phase II Study of OSI-774 and Temozolomide in Combina-
tionwith Radiation Therapy in Glioblastoma Multiforme
N0272 Phase I/II Trial of Imatinib Mesylate; (Gleevec; STI-571) in Treatmentof
Recurrent Oligodendroglioma and Mixed Oligoastrocytoma
N027D A Phase I Study of CCI-779 and Temozolomide in Combination
withRadiation Therapy in Glioblastoma Multiforme
N047B A Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA) in
Patientswith Recurrent Glioblastoma
N0572 A Phase I/II Trial of Sorafenib and CCI-779 in Patients with Recurrent-
Glioblastoma
N0574 A Phase III Randomized Trial of the Role of Whole Brain Radiation-
Therapy in Addition to Radiosurgery in the Management of Patients
withOne to Three Cerebral Metastases - pre registration
Other Closed Trials
CNS NCCTG CNS Committee Table of Contents - Page 1 of 3
Program Status Reports for NEURO-ONCOLOGY - September 2007
937252 Phase III Trial of BCNU and Cisplatin Versus BCNU Alone and Stan-
dardRadiation Therapy Versus Accelerated Radiation Therapy in
PatientsWith Grade 4 Glioma
937351 Phase II Trial of Chemotherapy Plus Radiotherapy for Management
ofPrimary Central Nervous System Non-Hodgkin's Lymphoma
(PCNSL)
987252 A Phase II Trial of Preirradiation Chemotherapy With BCNU, Cispl-
atin,and Oral Etoposide Combined With Radiation Therapy in the Treat-
ment ofGrade 4 Astrocytoma (Glioblastoma)
N0074 Phase II Study of ZD1839 (NSC 715055) in Newly Diagnosed Patients
withGlioblastoma (Grade 4 Astrocytoma)
N997D Pilot and Phase II Trial of Irinotecan and Radiation Followed byIrinote-
can and BCNU in Glioblastoma Multiforme Patients
Protocol Concepts
N0577 Phase III Study of Radiotherapy With or Without Concomitant andAdju-
vant Temozolomide in Newly Diagnosed Anaplastic Oligodendrogliom-
aPatients with 1p and/or19q gene deletions and Phase II Study
ofRadiotherapy with Concomitant and Adjuvant Temozolomide in
Patientswith 1p and 19q intact
N057K Phase I/II Evaluation of Everolimus (RAD001), Radiation andTemozo-
lomide (TMZ) Followed by Adjuvant Temozolomide and Everolimus
inNewly Diagnosed Glioblastoma
N057N Response to Pre-Radiation Chemotherapy as a Predictor of Survival
inPatients with Newly Diagnosed Malignant Astrocytoma
Database Studies
N0477 Optimizing EGFR Inhibitor-Based Therapies for GBM
Other
8073 Phase II Study of Suberoylanilide Hydroxamic Acid in Combination
withBortezomib in Patients With Recurrent Glioblastoma Multiforme
CNS NCCTG CNS Committee Table of Contents - Page 2 of 3
Program Status Reports for NEURO-ONCOLOGY - September 2007
967351 Primary Central Nervous System Non-Hodgkin's Lymphoma (PCNSL):
A PhasII Clinical Trial of Radiation Therapy and High Dose Corticos-
teroidsfor Elderly Patients (70 Years of Age and Older)
N0776 Phase II Trial of Bevacizumab in Combination with Sorafenib inRecur-
rent Glioblastoma Multiforme
N0777 Phase I/II Evaluation of ABT-888 in Combination with Radiation Ther-
apy(RT) Alone or RT and Temozolomide in High-Grade Glioma
CNS NCCTG CNS Committee Table of Contents - Page 3 of 3
NCCTG Status Report for Study 0525 - September 2007
Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-
Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma
Purpose of - Primary Goal
Study: 1) To determine if dose-intensifying (increasing the “dose-density”) the adju-
vant temozolomide component of the chemoradiation treatment enhances
treatment efficacy as measured by overall survival.
- Secondary Goals
1) To determine if dose-intensifying the adjuvant temozolomide component of
the chemoradiation treatment enhances treatment efficacy as measured by
progression-free survival.
2) To determine in patients with unmethylated MGMT if dose-intensifying the
adjuvant temozolomide component of the chemoradiation treatment
enhances treatment efficacy (overall and progression-free survival) com-
pared with patients receiving conventional temozolomide dosing.
3) To determine in patients with methylated MGMT if dose-intensifying the
adjuvant temozolomide component of the chemoradiation treatment
enhances treatment efficacy (overall and progression-free survival) com-
pared with patients receiving conventional temozolomide dosing.
4) To determine if there is an association between tumor MGMT gene methy-
lation status and treatment response.
5) To compare and record the toxicities of the conventional and dose-intense
chemotherapy regimens.
6) To evaluate whether 6-month progression-free survival is associated with
overall survival.
Study Chairs: M. R. Gilbert, M.D. NCCTG Study P. Brown, M.D.
Chair:
Status: 09/29/2006 Activated Projected Number of Patients: 834
Schema: Register
Randomize
Arm 1 - TMZ
Arm 2 - TMZ
This is an RTOG coordinated study. The full report from the coordinating group can be viewed
as part of the on-line meeting book at ncctg.mayo.edu.
NCCTG Status Report for Study 947252 - September 2007
Diagnostic and Prognostic Markers in High-Grade Glioma
Purpose of 1) To evaluate diagnostic and prognostic relevance of alterations of specific
Study: chromosomes and chromosomal regions using PCR analysis of microsatel-
lite repeats and FISH.
2) To evaluate diagnostic and prognostic relevance of DNA ploidy by flow
cytometric analysis and compare this with ploidy determinations by FISH.
3) To assess diagnostic and prognostic relevance of various markers of cellular
proliferation and cellular function
Study Chairs: Jan C. Buckner M.D. QC Specialist: Helen J Tollefson
Paul L. Schaefer M.D.
Statistician: Wenting Wu Ph.D. Nurse Resource:
Status: 11/28/1995 Activated Projected Number of Patients: 99999
Excluded: None Final Accrual: NA
Stratification None
Schema: PCR, FISH, flow cytometry & immunohistochemical determinations
performed in laboratory of Dr. R. B. Jenkins & the Mayo Cancer Center
Pathology Laboratory
Treating Schedule:
All treatment information is contained in the computer files for the
glioma therapy trials in which the patients were enrolled.
Study Design: Original Design: This prognostic factors study was originally designed to eval-
uate a battery of tumor markers in patients with grade-3 astrocytomas (AA) or high-grade oli-
goastrocytomas (AOA) who were enrolled in 3 NCCTG randomized clinical trials in newly-
diagnosed high-grade gliomas (79-72-51, 85-72-51, 88-72-52). The dataset would consist of
the prospectively-collected clinical data from these 3 trials together with associated baseline
tumor marker data measured on paraffin-embedded tissue collected from each of the clinical tri-
als participants at the time s/he enrolled in the trial.
During 1997, the eligible patients were identified, and paraffin blocks were collected from 108
of them. Each block was audited to determine if tumor was present. Specimens from 85
patients were found suitable for further marker analysis. Sections from these blocks were cut,
and flow cytometry, immunohistochemical staining for PCNA, MIB-1, and p53, and image
cytometry analysis of DNA ploidy were performed. During 1998, a comprehensive FISH analy-
sis of these specimens and screening for PTEN gene mutations was done.
CNS NCCTG CNS Committee 947252 - Page 1 of 5
NCCTG Status Report for Study 947252 - September 2007
While the blocks were being collected from the NCCTG member institutions, several new
potential markers that could be measured in paraffin-fixed tissue were identified by participants
in the NCI-sponsored Glioma Markers Network (GMN) in which Mayo participated. Moreover,
the study team realized that, as written, protocol 94-72-52 did not require the accrual of tumors
from patients with GBM, i.e., grade-4 astrocytoma. In retrospect, this was an oversight because
this group of patients could provide comparable information about the incidence of marker
anomalies and the survival of patients with and without specific marker alterations.
REVISED DESIGN: Consequently, the protocol was rewritten to accrue paraffin-embedded tis-
sue specimens from patients with newly-diagnosed GBM who were enrolled in any of the Mayo/
NCCTG high-grade glioma clinical trials. To enhance the likelihood of finding the most prog-
nostic markers associated with this disease, NCCTG Translational Research Committee and the
GMN participants jointly agreed to include in the univariate and multivariate analyses to be done
in this protocol those promising GMN markers that were approved by both of them, and appen-
dices justifying 4 new markers were incorporated. The revised protocol was approved by mem-
ber IRBs during 1998.
Accrual: By the cutoff date for this report (9/10/07) tissue blocks had been received for 445
patients from 19 memberships who were enrolled in 16 Mayo/NCCTG trials for newly-diag-
nosed high-grade gliomas. One patient was entered from a Mayo trial for recurrent gliomas
erroneously. They comprise 23% of all patients enrolled in those 16 trials, as is shown in the
Accrual Table and the Trials Table below.
Patient Characteristics: The 445 enrolled patients consist of 164 women (37%) and 281 men.
Five are classified as ethnic minorities. Tissue has been reviewed for 415 patients; these are cur-
rently classified as 110 AAs, 27 AOAs, 272 GBMs, 3 gliosarcomas, and 3 high-grade oligoden-
drogliomas. Tissue for 30 patients have not been reviewed at the time of this report.
Available Information: Virtually complete and up-to-date clinical and follow-up data are avail-
able for all patients who participated in any of 16 Mayo/NCCTG clinical trials in newly-diag-
nosed high-grade glioma. Deaths have now been recorded for 382 (86%) of the 445 patients in
this study.
Study Status: The various markers discussed above have been evaluated on all but the most
recently acquired tissue, and several studies have been done. The following reports have been
presented.
Manuscripts:
CNS NCCTG CNS Committee 947252 - Page 2 of 5
NCCTG Status Report for Study 947252 - September 2007
* Aldape KD, Ballman K, Furth A, Buckner JC, Giannini C, Burger PC, Scheithauer BW, Jen-
kins RB, James CD. Immunohistochemical Detection of EGFRvIII In High Malignancy Grade
Astrocytomas and Evaluation of Prognostic Significance. J Neuropathol Exp Neurol. 2004
Jul;63(7):700-7.
* Kuriyama H, Lamborn KR, O'Fallon J, Iturria N, Sebo T, Schaefer P, Scheithauer BW, Buck-
ner JC, Kuriyama N, Jenkins RB, Israel MA. Prognostic significance of an apoptotic index and
an apoptosis/proliferation ratio for patients with high-grade astrocytomas. Neuro-Oncology
4:179-186, 2002.
* Smith JS, Tachibana I, Passe SM, Huntley BK, Borell TJ, Iturria N, O'Fallon JR, Schaefer PL,
Scheithauer BW, James CD, Buckner JC, Jenkins RB. PTEN tumor suppressor gene mutation
and EGFR amplification and outcome in patients with anaplastic astrocytoma and glioblastoma
multiforme. Journal of the National Cancer Institute 93:1246-1256, 2001.
* Perry A, Jenkins RB, O'Fallon JR, Schaefer PL, Kimmel DW, Mahoney MR, Scheithauer BW,
Smith SM, Hill EM, Sebo TJ, Levitt R, Krook J, Tschetter LK, Morton RF, BUckner JC. Clini-
copathologic study of 85 similarly treated patients with anaplastic astrocytic tumors: An analy-
sis of DNA content (ploidy), cellular proliferation, and p53 expression. Cancer 86:672-683,
1999.
Abstracts:
* Buckner JC, Aldape KD, Ballman K, Scheithauer BW, Burger PC, Giannini C, Schaefer PL,
Jenkins RB, James CD. Immunohistochemical detection of EGFRvIII and prognostic signifi-
cance in patients with malignant glioma enrolled in NCCTG clinical trials. Proc Am Soc Clin
Oncol 22:109s (abstract 1508), 2004.
* Rao RD, Jenkins RB, Scheithauer BW, O'Fallon JR, Furth AF, Iturria N, Giannini C, Schaefer
P, Buckner JC. Correlations between phenotype and cytogenetic aberrations in high grade astro-
cytomas. Proc Am Soc Clin Oncol 22:106 (abstract 422), 2003.
* Buckner JC, Scheithauer BW, O'Fallon JR, Schaefer P, Giannini C, Ballman K, Jenkins R.
P53, EGFR, and PTEN as markers of diagnosis and prognosis in patients with anaplastic glioma
enrolled in NCCTG clinical trials. Proc Am Soc Clin Oncol 22:98 (abstract 393), 2003.
Additional Information: The following are more abstracts that have been presented:
* Kitange GJ, Iturria N, Schaefer PL, O'Fallon JR, Buckner JC, Jenkin RB. Hypermethylation
and MGMT promoter in patient survival in human high-grade astrocytic gliomas. Accepted,
poster presentation, AACR. Proc Am Asso Cancer Res 43:49 (A247), 2002.
* Kuriyama H, Lamborn KR, O'Fallon J, Iturria N, Kuriyama N, Sebo TJ, Schaefer PL, Buckner
JC, Jenkins RB, Israel MA. Prognostic significance of an apoptosis/proliferation ratio for
patients with glioblastoma multiforme. Neuro-Oncology 2:276(A126), 2000.
CNS NCCTG CNS Committee 947252 - Page 3 of 5
NCCTG Status Report for Study 947252 - September 2007
* Imoto I, Huntley B, Borell T, O'Fallon JR, Mahoney MR, Hosek SM, Schaefer P, Scheithauer
BW, James CD, Buckner JC, Jenkins RB. Prognostic value of EGFR amplification, PTEN muta-
tion and TP53 mutation in anaplastic astrocytomas. Neuro-Oncology 1:326(A94), 1999.
* Perry A, Jenkins RB, O'Fallon JR, Mahoney MR, Scheithauer BW, Smith SM, Hill EM, Sebo
TJ Buckner JC. Clinicopathologic study of 66 uniformly treated anaplastic astrocytomas: An
analysis of DNA content (ploidy), cellular proliferation and p53 expression. Society for Neuro-
Oncology, 1998.
* Jenkins RB, Perry A, O'Fallon JR, Scheithauer BW, Smith S, Hill E, Sebo TJ, Buckner JC. An
evaluation of DNA content and markers of cellular proliferation in a cohort of uniformly-treated
patients with anaplastic astrocytoma. J Neuro-Oncol 39:100 (Abstract O-7), 1998.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Ann Arbor 1 0 0
Bismarck 11 0 0
Carle 14 0 0
Cedar Rapids 13 0 0
Des Moines 29 0 1
Duluth 20 0 0
Fargo 26 0 0
Grand Forks 3 0 0
Jacksonville 1 0 0
Mayo 224 5 9
Mo Valley 4 0 0
Ochsner 6 0 0
Peoria 30 0 0
Rapid City 8 0 0
Scottsdale 9 0 2
Sioux City 8 0 0
Sioux Falls 19 0 0
St. Cloud 9 0 0
Toledo 10 0 0
Total Membership Accrual 445 5 12
CNS NCCTG CNS Committee 947252 - Page 4 of 5
NCCTG Status Report for Study 947252 - September 2007
Tissue Accrual by Trials Table
PROTOCOL TISSUES
#
NUMBER PHASE AGENTS N %
PTS
79-72-51 3 BCNU vs DBD 229 16 7%
85-72-51 3 BCNU vs PCNU 346 91 26%
86-03-51 PILOT AHRT 18 10 56%
88-72-02 2 IFN+BCNU+RT 15 4 27%
88-72-03 PILOT AHRT+BCNU 6 3 50%
88-72-52 3 RT+BCNU +/- IFN 383 69 18%
90-72-01 1-2 RADIOSURG. + BCNU + RT 7 5 71%
91-72-01 PILOT BCNU+CDDP+VP16 18 8 44%
92-72-03 1 BCNU+CDDP+VP16 16 10 62%
93-72-52 3 BCNU+CDDP vs BCNU, and AHRT vs RT in GBMs 451 20 4%
98-72-51 2 BCNU+CDDP+VP16 in AAs 29 21 72%
98-72-52 2 BCNU+CDDP+VP16 in GBMs 93 48 52%
N0074 2 ZD1839 in GBMs 98 29 30%
N0177 1-2 OSI-774+RT 141 73 52%
N997D 1-2 CPT-11+BCNU in GBMs 58 25 43%
N027D 1 CCI-779+TMZ+RT in GBMs 12 12 100%
RECURR. 86-72-02 IFN+DFMO -- 1 --
TOTAL = 1920 445 23%
CNS NCCTG CNS Committee 947252 - Page 5 of 5
NCCTG Status Report for Study 947253 - September 2007
Diagnostic and Prognostic Markers in Low-Grade Glioma
Purpose of 1) To evaluate diagnostic and prognostic relevance of alterations of specific
Study: chromosomes & chromosomal regions using PCR analysis of microsatellite
repeats and FISH.
2) To evaluate diagnostic and prognostic relevance of DNA ploidy by flow
cytometric analysis and compare this with ploidy determinations by FISH.
3) To assess diagnostic & prognostic relevance of various markers of cellular
proliferation and cellular function.
Study Chairs: Jan C. Buckner M.D. QC Specialist: Helen J Tollefson
Robert M. Arusell M.D.
Statistician: Wenting Wu Ph.D. Nurse Resource:
Status: 12/01/1995 Activated Projected Number of Patients: 99999
Excluded: 2 Final Accrual: NA
Stratification None
Schema: PCR, FISH, flow cytometry, & immunohistochemical determinations
performed in the laboratory of Dr. R. B. Jenkins & the Mayo Cancer
Center Pathology Laboratory
Study Design: Original Design: This prognostic factors study was designed to evaluate a bat-
tery of tumor markers in patients with low-grade astrocytomas, oligodendrogliomas, or mixed
oligoastrocytomas who were enrolled in 2 clinical trials for newly-diagnosed low-grade gliomas,
i.e., the first NCCTG-led intergroup phase-III trial in this population (86-72-51) and a then-
ongoing Mayo/NCCTG phase-II trial (93-72-02). The dataset will consist of the prospectively-
collected clinical data from these 2 trials together with associated baseline tumor marker data
measured on paraffin-embedded tissue collected from each of the clinical trials participants at
the time s/he enrolled in the trial.
While the blocks were being collected from the NCCTG member institutions, several new
potential markers that could be measured in paraffin-fixed tissue were identified by participants
in the NCI-sponsored Glioma Markers Network (GMN) to which Mayo belongs.
Revised Design: In order to enhance the likelihood of finding the most prognostic markers
associated with this disease, the NCCTG Translational Research Committee and the GMN par-
ticipants jointly agreed to include in the univariate and multivariate analyses to be done in this
protocol those promising GMN markers that were approved by both of them. Appendices justi-
fying the new markers were added to the original protocol, and the revised protocol was
approved by the NCCTG IRBs during 1998.
CNS NCCTG CNS Committee 947253 - Page 1 of 3
NCCTG Status Report for Study 947253 - September 2007
Accrual: This study was activated by NCCTG on 12/1/95. By the cutoff date for this report (8/
14/06), blocks from 135 patients from 12 memberships had been registered for this study, as
shown in the Accrual Table. These comprise blocks from 134 (49%) of the 275 patients enrolled
in the 2 low-grade glioma trials (100/232 in 86-72-51, 34/43 in 93-72-02) plus one erroneously
registered block from a GBM patient enrolled in 98-72-52.
Currently, there are 128 eligible registrations and 7 registrations that have been disqualified for
various reasons. One patient cancelled out of 93-72-02 between registration and submission of
pathology materials, and 6 blocks were declared ineligible for this study. In addition to the
GBM block improperly registered into this study instead of the corresponding high-grade
glioma study (94-72-52), the blocks for 4 patients enrolled in low-grade glioma trials were
declared ineligible upon routine neuropathology review. Two were reclassified as high-grade
glioma (1 AA, 1 AOA); one was classified as a ganglioma; and one could not be definitively
classified as astrocytoma, oligodendroglioma, or oligoastrocytoma. A sixth block was typed as
astrocytoma but was not graded by the neuropathologist due to concern about the representative-
ness of the biopsy sample.
Patient Characteristics: The 135 patients with blocks registered for this study consist of 54
women (40%) and 81 men. One is classified as an ethnic minority. The histologic classifica-
tions for the 128 eligible blocks are summarized in the Histologic Classification Table included
in the Spring 2006 report.
Available Information: Virtually complete and up-to-date clinical and follow-up data are avail-
able for all patients who participated in either of the 2 NCCTG clinical trials in newly-diagnosed
low-grade glioma. Deaths have now been recorded for 81 (60%) of the patients registered to this
study.
Study Status: Acquisition of tissue blocks from patients enrolled in the recently-closed low-
grade clinical trial continues. Eighty-one deaths are documented in this prognostic factors study
-- 50% of the 165 so far recorded in the 2 low-grade glioma trials (150 in 86-72-51, 15 in 93-72-
02).
The following reports have been presented.
Manuscripts:
* Jenkins RB, Blair H, Ballman KV, Giannini C, Arusell RM, Law M, Flynn H, Passe S, Felten
S, Brown PD, Shaw EG, Buckner JC: A t(1;19)(q10;p10) Mediates the Combined Deletions of
1p and 19q and Predicts a Better Prognosis of Patients with Oligodendroglioma. Cancer Res.
2006 Oct 15;66(20):9852-61.
CNS NCCTG CNS Committee 947253 - Page 2 of 3
NCCTG Status Report for Study 947253 - September 2007
* Buckner JC, Gesme D Jr, O'Fallon JR, Hammack JE, Stafford S, Hawkin R, Scheithauer BW,
Erickson BJ, Levitt R, Shaw EG, Jenkins RB. Phase II Trial of Procarbazine, CCNU, and Vinc-
ristine (PCV) as Initial Therapy for Patients with Low-Grade Oligodendroglioma or Oligoastro-
cytoma: Efficacy and Associations with Chromosomal Abnormalities. J Clin Oncol 21:251-255,
2003.
Abstracts:
* Jenkins RB, Ballman KV, Giannini C, Arusell RM, Blair H, Flynn H, Passe S, Brown PD,
Shaw EG, Buckner JC. NCCTG 94-72-53: Diagnostic and prognostic significance of a
t(1;19)(q10;p10) in patients (pts) with log-grade oligodendroglioma and astrocytoma. Am Soc
Clin Oncol 2006 (submitted).
* Jenkins RB, Blair H, Flynn H, Passe S, Law M, Ballman K, Aldape K, Giannin C, Buckner
JC. A t(1;19)(q10;p10) mediates the combined deletions of 1p and 19q in human oligodendro-
gliomas. Am Asso Cancer Res (submitted 2006) Oral presentation.
* Buckner JC, Ballman KV, Scheithauer BW, Arusell RM, Blair HE, Passe SM, Brown PD,
Jaeckle K, Shaw EG Jenkins RB. NCCTG 94-72-53: Diagnostic and prognostic significance of
1p and 19q deletions in patients (pts) with low-grade oligodendroglioma and astrocytoma. Proc
Am Soc Clin Oncol 23(16s, pt I):114s (abstract 1502), 2005.
* Buckner JC, Smith JS, Nelson DR, Zenk D, Shevlin BE, Hammack JE, Borell TJ, O'Fallon
JR, Scheithauer BW, Jenkins RB. Phase II Trial of Procarbazine, CCNU, and Vincristine (PCV)
as Initial Therapy in Patients with Low-Grade Oligodendrogliomas or Oligoastrocytoma: Effi-
cay Results and Associations with Chromosome 1p and 19q Loss. Proc Amer Soc Clin Oncol
18:140a(A536), 1999, and unpublished data.
Accrual Table:
Randomizing Total
Membership Entered
Ann Arbor 1
Bismarck 4
Carle 4
Cedar Rapids 1
Des Moines 13
Duluth 1
Fargo 17
Grand Forks 3
Mayo 84
Ochsner 2
Sioux City 3
Sioux Falls 2
Total Membership Accrual 135
CNS NCCTG CNS Committee 947253 - Page 3 of 3
NCCTG Status Report for Study 949452 - September 2007
Clinical Significance of Histologic Typing of High-Grade Glioma
Purpose of 1) To estimate (describe) time-to-progression & time-to-death distributions for
Study: selected cell types of high-grade tumors.
2) To identify clinical and histologic characteristics associated with time-to-
progression and/or time-to-death.
3) To identify prognostic groups based on clinical and histologic characteris-
tics, ones possibly more predictive of survival than clinical or morphologic
parameters alone.
Study Chairs: Jan C. Buckner M.D. QC Specialist: Helen J Tollefson
Statistician: Wenting Wu Ph.D. Nurse Resource:
Status: 11/28/1995 Activated Projected Number of Patients: 950
10/18/1996 Perm. Closed
Excluded: None Final Accrual: NA
Stratification None
Schema: Slides revewed by Dr. Scheithauer according to WHO criteria. Data
entered into neuropathology database.
Treating Schedule:
No treatment information
Study Design: ORIGINAL DESIGN: This prognostic factors study was designed to identify
clinical and histologic characteristics associated with time-to-progression and time-to-death in
patients with newly-diagnosed high-grade glioma who enrolled in the first 3 NCCTG high-grade
glioma phase-3 clinical trials (79-72-51, 85-72-51, 88-72-52). The dataset consisted of the pro-
spectively-collected clinical data from these 3 trials together with associated baseline pathology
data measured on paraffin-embedded tissue collected from each of the clinical trials participants
at the time s/he enrolled in the trial. The primary hypotheses to be tested were:
* The following morphologic criteria impart an inferior prognosis when compared with pure
fibrillary astrocytoma of the same grade: gemistocytic, small cell, giant cell, or sarcomatous ele-
ments.
* Tumors which contain oligodendroglial features are associated with superior survival when
compared with pure fibrillary astrocytoma of the same grade.
* Small cell and sarcomatoid features are associated with increased risk of clinically apparent
leptomeningeal dissemination compared with pure fibrillary astrocytoma.
CNS NCCTG CNS Committee 949452 - Page 1 of 4
NCCTG Status Report for Study 949452 - September 2007
Patient histories were reviewed to ascertain whether or not meningeal dissemination was docu-
mented antemortem. Johns Hopkins neuropathologist Peter Burger reviewed all cases with mor-
phologic features described above as well as a subset of pure fibrillary astrocytomas, grade 3
and 4, as suggested by NCI.
REVISED DESIGN: The dataset created for the original study proved to be so useful that it
was expanded into a Neuropathology Databank, which includes pathology reviews by Bernd
Scheithauer of the slides submitted for all the patients enrolled in MCCC/NCCTG glioma trials,
those for recurrent and low-grade glioma as well as those for subsequent high-grade glioma tri-
als.
Accrual: ORIGINAL STUDY: The original Clinical Significance of Histologic Typing in
High-Grade Glioma study was activated by NCCTG on 11/28/95 and closed to accrual on 10/18/
96. Approximately 30 of the 950 participants in the 3 designated trials are known to have miss-
ing tissue. Tissue slides for 827 participants (90% of the remaining 920) were submitted by 19
memberships for re-review; these contributions were tabulated by membership in the 1998
Meeting Book. All available tissue samples have now been reviewed.
NEUROPATHOLOGY DATABANK: On 9/13/07, a total of 2968 tumors are registered in the
Neuropathology Databank. Reasonably complete pathology slide information is available for
2521 newly-diagnosed gliomas and 360 recurrent gliomas. In addition, there are 35 primaries
and 27 recurrences with nondiagnostic tissue, lost slides, celltypes that were either ineligible for
their parent protocol or that the Databank was not designed to collect (ependymoma, ganglioma,
neurocytoma) or had one or more key pathology data items missing; and slides for 25 registered
tumors are missing altogether.
Currently, there are 25 patients with 2-3 recurrent tumors each, and 273 patients with both pri-
mary and recurrent pathology slides in the Databank. The following tables summarize (a)
celltype x grade and (b) clinical trial participation separately for newly-diagnosed vs recurrent
cases.
Patient Characteristics: ORIGINAL STUDY: The 827 patients consisted of 337 women
(41%) and 490 men. Six were classified as ethnic minorities.
NEUROPATHOLOGY DATABANK: Patient data are available in the clinical trials research
files but are not yet summarized in the Neuropathology Databank.
Available Information: Up-to-date clinical and follow-up data are available in the clinical trials
research files for nearly all patients. Possible exceptions are those who were classified as ineli-
gible for the clinical trials in which they were registered.
CNS NCCTG CNS Committee 949452 - Page 2 of 4
NCCTG Status Report for Study 949452 - September 2007
In January 1997, Johns Hopkins neuropathologist Peter Burger reviewed, in blinded fashion,
slides for 150 patients with tissue officially classified as: high-grade oligoastrocytoma (N=59),
grade-3 astrocytoma (N=59), gliosarcoma (N=16), and a matched set of grade-4 astrocytomas
(N=16).
Study Status: The following reports have been presented:
Manuscripts:
* Galanis E, Buckner J, Kimmel D, Jenkins R, Alderet B, O'Fallon J, Wang CH, Scheithauer
BW, James CD. Gene amplification as a prognostic factor in primary and secondary high-grade
malignant gliomas. International Journal of Oncology 13:717-724, 1998.
* Galanis E, Buckner JC, Dinapoli RP, Scheithauer BW, Jenkins RB, Wang CH, O'Fallon JR,
Farr G. Clinical outcome of gliosarcoma compared wit glioblastoma multiforme: North Central
Cancer Treatment Group results. Journal of Neurosurgery 89:425-430, 1998.
Abstracts:
* Jaeckle KA, Decker PA, Ballman KV, Flynn PJ, Giannini C, Scheithauer BW, Jenkins RB,
Buckner JC. Analysis of paired glioma tissues of initial diagnosis and recurrent in patients
enrolled on NCCTG clinical trials: de-differentiation and association with survival. Am Soc Clin
Oncol 2006 (submitted)
* Jaeckle KA, Ballman KV, Decker PD, Giannini C, Scheithauer B, Buckner JC. Clinical prog-
nostic factors in long-term survivors from a database of 1651 patients with newly diagnosed
glioblastoma (GBM) treated on prospective North Central Cancer Treatment Group (NCCTG)
trials. Submitted to the 2006 International Brain Tumor Research and Therapy Meeting, April
26-30, 2006, Napa Valley, CA.
* Buckner JC, Scheithauer B, Dinapoli RP, Votava JH, Giannini C, Iturria N, O'Fallon J. Com-
parison of mixed anaplastic oligoastrocytom and high-grade astrocytoma in North Central Can-
cer Treatment Group clinical trials of high-grade glioma. Proc Am Soc Clin Oncol 70:77a(A
305), 2002. Poster Discussion presentation.
* Rao R, Scheithauer B, Giannini C, Iturria N, O'Fallon J, Schaefer P Buckner JC. Prognostic
significance of histologic subtyping in high grade astrocytoma: North Central Cancer Treatment
Group Results. Proc Am Soc Clin Oncol 21:70a (A283), 2002. Platform presentation; Merit
Award.
* Buckner JC, Scheithauer BW, O'Fallon JR, Wang CH, Dinapoli RP, Schomberg PJ, Far G,
Schaefer P. Superior survival of patients with anaplastic oligoastrocytoma (AOA) vs anaplastic
astrocytoma (AA) or glioblastoma multiforme (GBM). Society of Neuro-Oncology 1997.
CNS NCCTG CNS Committee 949452 - Page 3 of 4
NCCTG Status Report for Study 949452 - September 2007
* A workshop to permit NCCTG pathologists to review, in blinded fashion, a representative
subset of the 150 slides classified by both Bernd Scheithauer and Peter Burger was conducted by
the NCCTG Pathology Committee at its 1997 Fall Meeting.
Additional Information: The following manuscript is being prepared:
* Buckner JC, Scheithauer BW, O'Fallon JR, Dinapoli RP, Schomberg PJ, Farr G, Schaefer P:
Superior Survival of Patients with Anaplastic Oligoastrocytoma Versus Anaplastic Astrocytoma
or Glioblastoma Multiforme.
Table 1: Newly-Diagnosed and Recurrent Glioma Tissue, by Celltype & Grade
NEWLY-DIAGNOSED RECURRENT
CELLTYPE TISSUES GRADE TISSUES GRADE
N % 1 2 3 4 N % 1 2 3 4
ASTROCYTOMA 2070 82% 23 82 222 1743 228 63% 2 13 35 178
GLIOSARCOMA 39 2% -- -- -- 39 4 1% -- -- -- 4
OLIGOASTRO 209 8% -- 113 38 58 82 23% -- 23 39 20
OLIGO 203 8% 9 161 27 6 46 13% 1 26 16 3
TOTAL = 2521 32 356 287 1846 360 3 62 90 205
CNS NCCTG CNS Committee 949452 - Page 4 of 4
NCCTG Status Report for Study 969453 - September 2007
Factors Associated With, Response, Time to Progression and Overall Survival
in Recurrent Glioma Phase II Trials
Purpose of 1) To identify variables which may affect response, TTP, and OS in patients
Study: with recurrent glioma.
Study Chairs: Jan C. Buckner M.D. QC Specialist:
Paul L. Schaefer M.D.
Statistician: Wenting Wu Ph.D. Nurse Resource:
Status: 12/19/1996 Activated Projected Number of Patients: 375
12/22/2000 Perm. Closed
Stratification None
Schema: Not applicable
Treating Schedule:
Not applicable
Accrual: A total of 583 patients were accrued to this study from the 15 consecutive NCCTG
phase-II trials for recurrent glioma.
Patient Characteristics: The 583 patients that comprise this database consist of 210 (36%)
women and 374 men. Eight are classified as ethnic minorities. Median age at randomization to
the parent treatment trial was 50 with a range of 18-81.
Available Information: Of the 583 patients enrolled in these 15 trials, all have usable survival
and progression-time data, and had their available tissues reviewed by neuropathologist Berndt
Scheithauer. At the time the analysis file was frozen for final analysis, progressions had been
recorded for 514 (88%) of the 583 and 566 (97%) had died.
Study Status: The following reports have been presented.
Abstracts:
* Lamborn K, Wu W, Prados M, Jaeckle K, Chang S, Novotny P, Buckner J. Joint NABTC +
NCCTG prognostic factors analysis for high grade recurrent glioma. Proc Am Soc Clin Oncol
25(18s, pt 1):93s (abstract 2075), 2007
CNS NCCTG CNS Committee 969453 - Page 1 of 2
NCCTG Status Report for Study 969453 - September 2007
* Wu W, Lamborn K, Buckner J, Jaeckle K, Chang S, Novotny, Prados M: Joint NABTC +
NCCTG Prognostic Factors Analysis for High Grade Recurrent Glioma; Accepted, Oral Presen-
tation, Society for Neuro-Oncology, 2007
* Buckner JC, O'Fallon JR, Novotny P, Schaefer PL, Scheithauer BW: Determinants of time to
progression and overall survival of patients in clinical trials of recurrent glioma. Neuro-Oncol-
ogy 2:276(A30), 2000.
* Buckner JC, Ballman K, Schaefer P, Furth AF, Giannini C, Scheithauer BW, Galanis E,
Jaeckle KA. NCCTG 96-94-53: Clinical variables associated with overall survival (OS), pro-
gression-free survival (PFS), 6 month progression-free survival (PFS6), immediate progression
(ImmProg), and response in patients enrolled in recurrent glioma trials. Journal of Clinical
Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18s(June 20 Supple-
ment), 2006: 1520
A manuscript is in preparation.
CNS NCCTG CNS Committee 969453 - Page 2 of 2
NCCTG Status Report for Study N0177 - September 2007
A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination with
Radiation Therapy in Glioblastoma Multiforme
Purpose of - Treatment - Study 1 and 2
Study: 1) To determine MTD of OSI-774 and temozolomide combined with RT in this
patient population.
2) To determine the safety & tolerability of the recommended Phase II dose of
OSI-774 and temozolomide when combined with standard RT.
3) To describe the toxicities of the combination of OSI-774/temozolomide &
RT.
- Treatment - Study 3
1) To assess treatment effectiveness of the study regimen for this study group
primarily by survival at 52 weeks. Secondary endpoints include response
rate, progression free at 6 months, time to progression, and survival.
2) To characterize the toxicities of combined OSI-774/temozolomide & RT.
- Translational
1) To correlate tumor expression, amplification, mutation and phosphorylation
of EGFR with response to treatment with OSI-774/temozolomide & RT,
overall survival, and time to tumor progression. To correlate these same
efficacy endpoints with other potential molecular markers of response
assessed in tumor tissue.
2) Assess whether O(6)-methylguanine-DNA methyltransferase (MGMT)
expression or promotor methylation predict for improved survival using this
regimen.
3) To determine whether pretreatment serum sEGFR (soluble EGFR) concen-
trations are a useful prognostic indicator and whether altered and/or chang-
ing sEGFR concentrations are useful indicators of theapeutic responsiveness
and patient outcome.
Study Chairs: Paul D. Brown M.D. QC Specialist: Butch K. Kvittem CCRP
Francois J. Geoffroy M.D.
Statistician: Wenting Wu Ph.D. Nurse Resource: Beverly L Kowbel
Status: 12/13/2002 Activated Projected Number of Patients: 159
Excluded: 5 Final Accrual: NA
Stratification None
Factors:
Schema: Studies 1 & 2 open to Mayo Rochester, Jacksonville, Scottsdale, and
University of Alabama at Birmingham only:
Study 1 - For patients not on enzyme-inducing anticonvulsants (EIACs)
Register
OSI-774
CNS NCCTG CNS Committee N0177 - Page 1 of 14
NCCTG Status Report for Study N0177 - September 2007
RT + OSI-774/TMZ
OSI-774
OSI-774 + TMZ
Maintenance OSI-774
Study 2 - for patients on EIACs
Register
OSI-774
RT + OSI-774/TMZ
OSI-774
OSI-774 + TMZ
Maintenance OSI-774
Study 3 - (Entire NCCTG membership)
Register
OSI-774
RT + OSI-774/TMZ
OSI-774
OSI-774 + TMZ
Maintenance OSI-774
Treating Schedule:
Arm Agent Dose Route Days Freq
* OSI-774 Assigned by Ran- Oral Daily Daily until PROG
domization Center
* TMZ 75 mg/m2 Oral 7 days/week for 6 RT & Daily TMZ to start after 1
weeks during RT week of OSI-774 alone
* TMZ 200 mg/m2 daily Oral Days 1-5, week 1 Every 28 days for 6 cycles (to
begin 4 weeks after RT)
Arm Dose Days FX/Day FX/Size # FX RT Length
I 5000 cGy M-F 1 200 cGy 25 5 weeks
B 1000 cGy M-F 1 200 cGy 5 1 week
Chemotherapy Treatment
* = Studies 1, 2, & 3
Radiation treatment for studies 1, 2, & 3 - Begins along with TMZ on
day 8 of treatment with OSI-774. RT is given for 6 weeks.
I = Initial RT fields
B = Boost RT fields
Radiation Quality Control Report
CNS NCCTG CNS Committee N0177 - Page 2 of 14
NCCTG Status Report for Study N0177 - September 2007
Eligible cases entered & reviewed as of 8/06
Total cases: 129
% minor deviations: 7.8
% major deviations: 3.1
Study Design: This study consists of 3 separate clinical trials and associated translational stud-
ies in patients with newly-diagnosed glioblastoma multiforme (GBM), i.e. grade 4 astrocytoma:
(1) Study 1 (Arm A), a phase I trial designed to establish the maximum tolerated dose (MTD) of
OSI-774 when administered with RT to patients who are NOT receiving enzyme-induced anti-
convulsants (EIACs); (2) Study 2 (Arm B), a phase I trial designed to establish the MTD of OSI-
774 when administered with RT in patients who ARE receiving EIACs.
After the positive results of the EORTC Phase III trial for concomitant and adjuvant Temozolo-
mide and radiotherapy in newly diagnosed GBM were reported at ASCO 2004, all three studies
have been altered to include Temozolomide. Arm D (study 1), is a phase I trial designed to
establish the MTD of OSI-774+Temozolomide (TMZ)+RT followed by OSI-774+TMZ when
administered to patients NOT on EIACs; Arm E (study 2), is phase I trial designed to establish
the MTD of OSI-774+TMZ+RT followed by OSI-774+TMZ in patients receiving EIACs; (3)
Study 3 (Arm C), a phase II trial designed to assess the survival, time-to-progression, and toxic-
ities associated with OSI-774 + TMZ + RT followed by OSI-774 + TMZ in patients with newly-
diagnosed GBMs; and (4) translational studies to investigate the association between EGFR
abnormalities (and other laboratory variables) and clinical variables.
Study 3 is designed with two interim analyses to permit early reporting of drug activity if there
is strong evidence that the study regimen is either inactive or highly effective. These are sched-
uled to occur after the 35th and 60th eligible patient has been followed for 12 months.
Accrual: As of 08/06/07, there have been 141 patients enrolled; 11 on Arm A, 9 on Arm B, 21
in the modified Studies (adding TMZ): 8 on Arm D; 13 on Arm E; and 100 on Arm C (Study 3).
One patient on Arm A has been declared a major violation; two patients have cancelled (one on
Arm C and one on Arm D); and 2 patients on Arm C have been declared ineligible. Accrual
information is in the accrual table below. The phase I portion of the trial has been completed for
the Non-EIAC patients. Arm E is open to accrue one additional patient. Study 3 (Arm C) closed
to accrual on July 14, 2006.
Patient Characteristics: Available baseline information is summarized in the Baseline Charac-
teristics Table below. The patients are 85 men (60%) and 56 women, ranging in age from 31 to
84 (median age = 57). One of the 141 patients is classified as a minority.
Available Information: As of 08/06/07, randomization information is available for all patients,
but only 108 are fully evaluable. At this time, 91 patients have died.
CNS NCCTG CNS Committee N0177 - Page 3 of 14
NCCTG Status Report for Study N0177 - September 2007
Adverse Events: Adverse Event information is available for 133 patients (10 on Arm A, 9 on
Arm B, 95 on Arm C, 7 on Arm D and 12 on Arm E). All grade 4 and 5 reported AEs regard-
lesss of attribution and the most frequent grade 1,2 and 3 AEs are summarized in the Adverse
Events Table below. Currently, six grade 5 events have been reported: 1 cardiovascular on Arm
A, considered not related to study treatment; 1 infection-no ANC on Arm C, considered possibly
related to treatment; 1 pneumonitis on Arm C, considered possibly related to treatment; 1
hypoxia on Arm D, considered not related to study treatment; 1 low consciousness, on Arm D,
considered to be probably related to study treatment; and 1 thrombosis, on Arm E, considered
unlikely related to study treatment.
On Arm D, six patients reported at least one grade 3 or higher adverse event. Of these, two
(29%) patients reported grade 3/4 hematological events: one reported leukopenia, neutropenia,
both grade 4 and thrombocytopenia, grade3; the other patient reported grade 4 leukopenia, neu-
tropenia and thrombocytopenia and grade 3 anemia. These are the same two patients that experi-
enced a grade 5 event.
On Arm E, four patients reported at least one grade 3 or higher adverse event that was consid-
ered at least possibly related to treatment. An additional 4 patients also reported at least one
grade 3 or higher event, but were considered not related or unlikely related to study treatment.
One patient reported 2 grade 4 events (constipation and ileus, both considered possibly related to
study treatment). One grade 5 event was reported: thrombosis, considered unlikely related to
treatment.
Of the 95 patients evaluable for AEs on Arm C, seventy-five (79%) have reported at least one
grade 3+ adverse event. Twenty-two (23%) have reported at least one grade 4 adverse event, of
these patients only fifteen patients had at least one grade 4 events considered related to treat-
ment. Eight patients reported at least one grade 4 hematological adverse event considered at
least possibly related to study treatment.
Study Status: Arms A and B are permanently closed. Arm D is permanently closed. This study
is still in the phase I portion for patients on EIACs (Arm E). At the time of this report Arm E is
open to accrual. Study 3 (Arm C) is permanently closed to accrual.
Additional Information: This study has been amended to add Temozolomide (TMZ) to the
treatment regimen in all studies. The Phase I portions (studies 1 and 2) have accrued patients to
establish a tolerable dose of OSI-774 when combined with TMZ and RT. The Phase II portion
(study 3) is currently closed. We are awaiting for data maturity to assess efficacy. The first
interim analysis was conducted and it yielded inconclusive results.
A poster was presented at ASCO 2005 reporting on the patients enrolled on Arms A and B. The
abstract is presented later in this report.
CNS NCCTG CNS Committee N0177 - Page 4 of 14
NCCTG Status Report for Study N0177 - September 2007
* Krishnan S, Brown P, Ballman K, Fiveash J, Uhm J, Giannini C, Geoffroy F, Nabors L, Buck-
ner J. Phase I trial of erlotinib with radiation therapy (RT) in patients with glioblastoma multi-
forme (GBM).
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Allegheny WP 3 0 0
Ann Arbor 1 0 0
Bismarck 2 0 0
Carle 7 0 0
Des Moines 9 0 0
Duluth 1 0 0
Fargo 2 0 0
Georgia CCOP 1 0 0
Jacksonville 15 0 0
Lehigh 2 0 0
MN CGOP 3 0 0
Mayo 60 3 4
Metro MN 4 0 0
Mo Valley 6 0 0
Peoria 10 0 0
Scottsdale 5 0 2
Sioux City 1 0 0
St. Cloud 4 0 0
Wichita 5 0 0
Total Membership Accrual 141 3 6
Baseline Characteristics Table:
Arm Arm Arm Arm Arm
Characteristics
A B C D E
Gender
f 4 2 43 4 3
m 7 7 57 4 10
Race
White 11 9 98 8 12
Black or African American 0 0 1 0 0
Not reported: patient refused or not ava 0 0 1 0 0
Unknown: Patient unsure 0 0 0 0 1
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 10
Arm B Evaluable Patients: 9
Arm C Evaluable Patients: 95
Arm D Evaluable Patients: 7
Arm E Evaluable Patients: 12
CNS NCCTG CNS Committee N0177 - Page 5 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 1 10 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 23 24 7 7 6 6 0 0
D 3 43 0 0 2 29 0 0
E 4 33 1 8 0 0 0 0
LEUKOPENIA A 0 0 1 10 0 0 0 0
B 1 11 0 0 0 0 0 0
C 30 32 15 16 7 7 0 0
D 5 71 0 0 2 29 0 0
E 6 50 1 8 0 0 0 0
ANEMIA A 1 10 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 18 19 5 5 0 0 0 0
D 1 14 1 14 0 0 0 0
E 4 33 0 0 0 0 0 0
LYMPHOPENIA A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 7 7 10 11 0 0 0 0
D 0 0 1 14 0 0 0 0
E 2 17 0 0 0 0 0 0
THROMBOCYTOPENIA A 3 30 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 39 41 16 17 5 5 0 0
D 3 43 1 14 1 14 0 0
E 7 58 0 0 0 0 0 0
TRANSFUSION-PLT A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 2 2 0 0 0 0
D 0 0 1 14 0 0 0 0
E 0 0 0 0 0 0 0 0
Cardiovascular HYPOTENSION A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 3 3 0 0 0 0 0 0
D 0 0 1 14 0 0 0 0
E 0 0 0 0 0 0 0 0
THROMBOSIS A 0 0 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 3 3 3 3 0 0
D 0 0 0 0 0 0 0 0
CNS NCCTG CNS Committee N0177 - Page 6 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
E 0 0 2 17 1 8 0 0
CARDIOVASCULAR A 0 0 0 0 0 0 1 10
B 0 0 0 0 0 0 0 0
C 1 1 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Coagulation PTT A 0 0 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
PROTHROMBIN TIME A 0 0 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Constitutional Symptoms FATIGUE A 4 40 1 10 0 0 0 0
B 2 22 2 22 0 0 0 0
C 58 61 13 14 3 3 0 0
D 3 43 0 0 0 0 0 0
E 9 75 2 17 0 0 0 0
WEIGHT LOSS A 0 0 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 19 20 1 1 0 0 0 0
D 2 29 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
CONSTITUTIONAL SYMPT A 0 0 0 0 1 10 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 1 1
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Dermatology/Skin ALOPECIA A 4 40 0 0 0 0 0 0
B 6 67 0 0 0 0 0 0
C 35 37 0 0 0 0 0 0
D 4 57 0 0 0 0 0 0
E 3 25 0 0 0 0 0 0
DRY SKIN A 1 10 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 15 16 0 0 0 0 0 0
CNS NCCTG CNS Committee N0177 - Page 7 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
D 1 14 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
PRURITIS A 0 0 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 8 8 0 0 0 0 0 0
D 2 29 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
RASH A 7 70 0 0 0 0 0 0
B 8 89 0 0 0 0 0 0
C 67 71 13 14 1 1 0 0
D 2 29 3 43 0 0 0 0
E 9 75 1 8 0 0 0 0
Gastrointestinal ANOREXIA A 2 20 0 0 0 0 0 0
B 5 56 0 0 0 0 0 0
C 30 32 2 2 0 0 0 0
D 4 57 0 0 0 0 0 0
E 7 58 0 0 0 0 0 0
FLATULENCE A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 3 3 0 0 0 0 0 0
D 1 14 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NAUSEA A 3 30 0 0 0 0 0 0
B 5 56 0 0 0 0 0 0
C 56 59 3 3 0 0 0 0
D 3 43 0 0 0 0 0 0
E 6 50 0 0 0 0 0 0
STOMATITIS A 1 10 2 20 0 0 0 0
B 1 11 0 0 0 0 0 0
C 16 17 0 0 0 0 0 0
D 3 43 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
DEHYDRATION A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 1 1 6 6 0 0 0 0
D 0 0 1 14 0 0 0 0
E 0 0 1 8 0 0 0 0
DYSPHASIA-PHARYN RT A 1 10 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
CNS NCCTG CNS Committee N0177 - Page 8 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 0 0 1 1 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
COLITIS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 1 14 0 0 0 0
E 0 0 0 0 0 0 0 0
CONSTIPATION A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 23 24 1 1 0 0 0 0
D 3 43 0 0 0 0 0 0
E 5 42 0 0 1 8 0 0
ILEUS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 1 8 0 0
TASTE A 0 0 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 12 13 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
DYSPEPSIA A 0 0 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 3 3 0 0 0 0 0 0
D 1 14 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
VOMITING A 1 10 0 0 0 0 0 0
B 2 22 0 0 0 0 0 0
C 12 13 4 4 0 0 0 0
D 1 14 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 6 60 0 0 0 0 0 0
B 5 56 0 0 0 0 0 0
C 49 52 6 6 0 0 0 0
D 4 57 1 14 0 0 0 0
E 5 42 0 0 0 0 0 0
Hemorrhage HEMORRHAGE-CNS A 0 0 0 0 0 0 0 0
CNS NCCTG CNS Committee N0177 - Page 9 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
B 0 0 0 0 0 0 0 0
C 0 0 0 0 1 1 0 0
D 0 0 0 0 0 0 0 0
E 0 0 1 8 0 0 0 0
Hepatic SGOT (AST) A 1 10 1 10 0 0 0 0
B 1 11 0 0 0 0 0 0
C 19 20 1 1 0 0 0 0
D 1 14 0 0 0 0 0 0
E 4 33 1 8 0 0 0 0
SGPT (ALT) A 1 10 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 11 12 5 5 0 0 0 0
D 0 0 0 0 0 0 0 0
E 2 17 1 8 0 0 0 0
ALK PHOS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 12 13 0 0 0 0 0 0
D 1 14 0 0 0 0 0 0
E 6 50 0 0 0 0 0 0
BILIRUBIN A 0 0 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 20 21 2 2 0 0 0 0
D 3 43 0 0 0 0 0 0
E 3 25 1 8 0 0 0 0
Infection/Febrile Neutropenia INFECTION-NO ANC A 0 0 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 8 8 4 4 0 0 1 1
D 0 0 1 14 0 0 0 0
E 0 0 0 0 0 0 0 0
FEBRILE NEUTROPENIA A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 1 1 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Metabolic/Laboratory HYPOCALCEMIA A 0 0 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 3 3 1 1 0 0 0 0
D 1 14 0 0 0 0 0 0
E 2 17 1 8 0 0 0 0
CNS NCCTG CNS Committee N0177 - Page 10 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
HYPONATREMIA A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 2 2 1 1 0 0 0 0
D 1 14 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
HYPOKALEMIA A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 6 6 1 1 0 0 0 0
D 1 14 1 14 0 0 0 0
E 2 17 0 0 0 0 0 0
HYPOPHOSPHATEMIA A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 0 0 0 0
D 1 14 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
HYPERGLYCEMIA A 0 0 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 11 12 4 4 0 0 0 0
D 0 0 2 29 0 0 0 0
E 1 8 0 0 0 0 0 0
Musculoskeletal MUSCLE WEAKNESS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 1 1 4 4 0 0 0 0
D 0 0 1 14 0 0 0 0
E 1 8 2 17 0 0 0 0
Neurology SEIZURE A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 4 4 2 2 1 1 0 0
D 2 29 0 0 0 0 0 0
E 0 0 2 17 0 0 0 0
SPEECH A 0 0 0 0 0 0 0 0
B 0 0 1 11 0 0 0 0
C 1 1 1 1 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
LOW CONSCIOUSNESS A 0 0 0 0 0 0 0 0
B 0 0 1 11 0 0 0 0
C 0 0 2 2 0 0 0 0
D 0 0 0 0 0 0 1 14
CNS NCCTG CNS Committee N0177 - Page 11 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
E 0 0 1 8 0 0 0 0
CONFUSION A 0 0 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 4 4 5 5 1 1 0 0
D 0 0 0 0 1 14 0 0
E 2 17 0 0 0 0 0 0
ANXIETY A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 2 2 1 1 1 1 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NEURO-MOTOR A 1 10 1 10 1 10 0 0
B 1 11 0 0 0 0 0 0
C 3 3 2 2 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NEURO A 0 0 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 1 8 0 0 0 0
Ocular/Visular VISION A 1 10 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 2 2 2 2 0 0 0 0
D 0 0 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
Pain HEADACHE A 3 30 0 0 0 0 0 0
B 1 11 1 11 0 0 0 0
C 14 15 1 1 0 0 0 0
D 0 0 0 0 0 0 0 0
E 1 8 0 0 0 0 0 0
Pulmonary COUGH A 2 20 0 0 0 0 0 0
B 1 11 0 0 0 0 0 0
C 32 34 0 0 0 0 0 0
D 2 29 0 0 0 0 0 0
E 2 17 0 0 0 0 0 0
DYSPNEA A 1 10 1 10 0 0 0 0
B 0 0 0 0 0 0 0 0
C 14 15 4 4 4 4 0 0
CNS NCCTG CNS Committee N0177 - Page 12 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
D 1 14 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
PNEUMONITIS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 2 2 5 5 1 1 1 1
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
ARDS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 1 1 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
VOICE CHANGE A 1 10 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 0 0 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPOXIA A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 1 0 0 0 0
D 0 0 0 0 0 0 1 14
E 0 0 1 8 0 0 0 0
PULMONARY A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 2 2 1 1 0 0
D 0 0 0 0 0 0 0 0
E 0 0 0 0 1 8 0 0
Renal /Genitourinary VAGINITIS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
D 1 14 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Sexual/Reproductive Function MENSES-IRREGULAR A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 2 2 0 0 0 0
D 0 0 1 14 0 0 0 0
E 0 0 0 0 0 0 0 0
Maximum Grade Adverse Event A 3 30 5 50 1 10 1 10
B 6 67 3 33 0 0 0 0
CNS NCCTG CNS Committee N0177 - Page 13 of 14
NCCTG Status Report for Study N0177 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 18 19 52 55 19 20 3 3
D 1 14 4 57 0 0 2 29
E 3 25 6 50 2 17 0 0
CNS NCCTG CNS Committee N0177 - Page 14 of 14
NCCTG Status Report for Study N0272 - September 2007
Phase I/II Trial of Imatinib Mesylate; (Gleevec; STI-571) in Treatment of
Recurrent Oligodendroglioma and Mixed Oligoastrocytoma
Purpose of - Objectives
Study: 1) Study 1: To identify the MTD of imatinib in the study population currently
on EIAC therapy.
2) Study 2: To assess the efficacy of imatinib in the study population as mea-
sured by progression-free survival, response, and overall survival.
3) Study 3: To acquire pilot data on a patient group not traditionally eligible for
this study population (those having greater than 2 prior chemotherapy regi-
mens or 2 prior chemotherapy regimens for recurrent/progressive disease).
- Studies 1, 2, and 3
1) To examine the toxicity and safety of imatinib in the study population.
2) To perform a preliminary correlative study of 1p/19q alterations, aPDFGR
gene amplification and levels of related downstream signaling elements in
tumor tissue with clinical study endpoints.
3) To perform a descriptive correlative analysis of steady state pharmacokinetic
data regarding imatinib and active metabolites with the study endpoints.
* Study Endpoints
1) Study 1: The primary endpoint of this study is dose limiting toxicity for
patients receiving EIACs.
2) Studies 2 and 3: Primary endpoint for these studies is progression-free sur-
vival at 6 months. Secondary endpoints include: (1) confirmed response; (2)
percentage of patients progression-free at 12 & 18 months after start of
treatment; (3) progression-free survival; (4) overall time to death; and (5)
quality of life.
Study Chairs: Kurt A. Jaeckle M.D. QC Specialist: Butch K. Kvittem CCRP
Patrick J. Flynn M.D.
Statistician: S. Keith Anderson MS Nurse Resource: Beverly L Kowbel
Status: 06/20/2003 Activated Projected Number of Patients: 93
Excluded: 1 Final Accrual: NA
Stratification None
Factors:
Schema: Study 1:
Register
C) EIAC patients: Imatinib
Study 2:
Register
A) EIAC patients: Imatinib
B) Non-EIAC patients: Imatinib
CNS NCCTG CNS Committee N0272 - Page 1 of 9
NCCTG Status Report for Study N0272 - September 2007
Study 3:
Register
D) EIAC patients: Imatinib
E) Non-EIAC patients: Imatinib
Treating Schedule:
Arm Agent Dose Route Days Freq
A Imatinib* To be determined PO Twice daily Every 28 days (continuous with-
out break)
B Imatinib 300 mg PO Twice daily Every 28 days (continous without
break)
C Imatinib Call Random Cen- PO Divided and Every 28 days (continuous with-
ter for assigned administered twice out break)
dose level daily per Cohort
Dose Level
D Imatinib To be determined P.O. Twice daily Every 28 days (continuous with-
out break)
E Imatinib Imatinib 300 mg P.O. Twice daily Every 28 days (continuous with-
out break)
* Study 2: Arm A will not open until a dose level has been
established in Study 1 (Arm C)
Study Design: This study consists of three clinical trials in patients with oligodendroglioma or
mixed oligoastrocytoma. Study 1 is a phase I trial designed to establish the maximum tolerated
dose (MTD) of imatinib when given to patients who are receiving enzyme-inducing anticonvul-
sants (EIACs). Study 2 is a single-stage phase II trial designed to assess (a) the ability of ima-
tinib to extend progression-free survival in oligodendroglioma and mixed oligoastrocytoma, as
measured by 6-month progression-free survival from study registration, (b) the toxicities associ-
ated with this agent, and (c) associations between clinical variables, 1p/19q alterations, and var-
ious parameters related to alpha-PDFGR gene amplification. Study 2 has one planned interim
analysis after the 23rd eligible patient has been followed for 6 months. Study 3 is a pilot study
designed to obtain data with respect to survival, progression-free survival, response rate, and
toxicity associated with Imatinib in patients with >2 prior chemotherapy regimens (any combi-
nation adjuvant + recurrence) or 2 regimens given for recurrent/progressive disease. Studies 2
and 3 will initially open to patients not on EIACS and will open to patients on EIACs after the
conclusion of Study 1.
Accrual: The study opened to NCCTG on June 20th, 2003. As of August 6th, 2007, 22 patients
have been enrolled to Study 2 (Arm B) (with one major treatment violation), Study 1 (Arm C)
has enrolled 8 patients, and Study 3 (Arm E) has enrolled 3 patients. Accrual by membership is
summarized in the Accrual Table below.
CNS NCCTG CNS Committee N0272 - Page 2 of 9
NCCTG Status Report for Study N0272 - September 2007
Patient Characteristics: Available baseline information is summarized in the Baseline Charac-
teristics Table below. The 22 patients on study 2 are 11 males and 11 females (50%) ranging in
age from 30 to 83 years old (median age=45). The 8 patients on study 1 are 7 males and 1 female
(12.5%), ranging in age from 35 to 65 years old (median age=44.5). The 3 patients on study 3
are 1 male and 2 females (66%), ranging in age from 33 to 57 years old (median age=37).
Available Information: As of 8/6/2007, in study 2, 21 patients are evaluable and 12 patients
have died. In study 1, all 8 patients are evaluable and 5 patients have died. And in study 3, all 3
of the patients are evaluable and 1 patient has died.
Adverse Events: With Adverse Event information available for 20 patients in study 2, 8
patients in study 1, and 3 patients in study 3 (see Adverse Event Table below), one grade-5 event
has been reported, but it is not related to treatment. Sixteen grade-4 adverse events have been
seen in 7 patients, all in study 2. One patient had hemorrhage and seizure; another had thrombo-
sis, seizure, and vomiting; a third patient had seizure, hyponatremia, neuro-motor, and hemor-
rhage; personality change was observed in a fourth patient; a fifth patient experienced fatigue; a
sixth patient had dyspnea, hyperuricemia, thrombocytopenia and speech impairment; the last
patient experienced depression.
In study 1 there were 2 clinically relevant dose limiting toxicities in the first 6 patients ( one in
each cohort of 3 patients). One patient had a grade 3 hemorrhage and the other had a grade 3
low consciousness. An addendum was approved to accrue up to an additional 6 patients in
cohorts of 3. The two additional patients accrued so far to cohort 3 have not experienced any
grade 3 or higher adverse events.
Study Status: Study 2 (Arm B) and Study 3 (Arm E) are currently open to patients not taking
enzyme inducing anti-convulsants (EIACs). Study 1 (Arm C) is open to patients taking EIACs.
Additional Information: No additional information has been entered
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Bismarck 1 0 0
Carle 1 0 0
Des Moines 1 0 0
Jacksonville 5 1 1
Lehigh 1 1 1
Mayo 14 2 3
CNS NCCTG CNS Committee N0272 - Page 3 of 9
NCCTG Status Report for Study N0272 - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Metro MN 6 1 1
Mo Valley 1 0 0
Montana 1 0 0
Wichita 2 0 0
Total Membership Accrual 33 5 6
Baseline Characteristics Table:
Arm Arm Arm Arm Arm
Characteristics
A B C D E
Age Group
60 0 2 0 0 0
Corticosteroid Therapy
Yes 0 5 2 0 1
No 0 17 6 0 2
Extent Recurrence Resection
None 0 7 4 0 1
Biopsy 0 6 1 0 0
Subtotal Resection 0 6 1 0 2
Gross Total Resection 0 2 2 0 0
Extent Resection
None 0 4 1 0 0
Biopsy 0 7 4 0 2
Subtotal Resection 0 11 3 0 1
Gender
f 0 11 1 0 2
m 0 11 7 0 1
Histologic Grade
2 0 12 6 0 2
3 0 9 2 0 1
4 0 1 0 0 0
History Brain
Yes 0 3 1 0 1
No 0 19 7 0 2
Primary Histology Type
Oligo 0 11 3 0 3
OA 0 11 5 0 0
Prior Nitrosoureas
Yes 0 5 1 0 3
No 0 17 7 0 0
Recurrent Histology Type
CNS NCCTG CNS Committee N0272 - Page 4 of 9
NCCTG Status Report for Study N0272 - September 2007
Arm Arm Arm Arm Arm
Characteristics
A B C D E
Oligo 0 10 3 0 1
OA 0 8 3 0 1
Missing 0 3 2 0 1
Recurrent Tumor Grade
2 0 5 1 0 1
3 0 8 3 0 2
Missing 0 8 4 0 0
Grade 4/5 and Most Frequent Adverse Event Table:
Arm B Evaluable Patients: 20
Arm C Evaluable Patients: 8
Arm E Evaluable Patients: 3
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA B 10 50 2 10 0 0 0 0
C 2 25 0 0 0 0 0 0
E 1 33 0 0 0 0 0 0
LEUKOPENIA B 9 45 4 20 0 0 0 0
C 3 38 0 0 0 0 0 0
E 2 67 0 0 0 0 0 0
ANEMIA B 7 35 0 0 0 0 0 0
C 2 25 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
LYMPHOPENIA B 0 0 2 10 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
THROMBOCYTOPENIA B 9 45 0 0 1 5 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
ANEMIA-LEUKEM B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
LEUKOPENIA-PEDS B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Auditory/Hearing INNER EAR B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Cardiovascular THROMBOSIS B 0 0 0 0 1 5 0 0
CNS NCCTG CNS Committee N0272 - Page 5 of 9
NCCTG Status Report for Study N0272 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
EDEMA B 6 30 1 5 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Constitutional Symptoms FATIGUE B 12 60 2 10 1 5 0 0
C 2 25 0 0 0 0 0 0
E 2 67 0 0 0 0 0 0
WEIGHT LOSS B 3 15 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
CONSTITUTIONAL SYMPT B 1 5 0 0 0 0 1 5
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Dermatology/Skin DRY SKIN B 1 5 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
PRURITIS B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
RASH B 7 35 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
DERMATOLOGY B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Gastrointestinal ANOREXIA B 4 20 1 5 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NAUSEA B 9 45 0 0 0 0 0 0
C 4 50 1 13 0 0 0 0
E 1 33 0 0 0 0 0 0
STOMATITIS B 4 20 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 1 33 0 0 0 0 0 0
CONSTIPATION B 2 10 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
DYSPEPSIA B 4 20 0 0 0 0 0 0
CNS NCCTG CNS Committee N0272 - Page 6 of 9
NCCTG Status Report for Study N0272 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
VOMITING B 4 20 0 0 1 5 0 0
C 2 25 1 13 0 0 0 0
E 0 0 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM B 6 30 1 5 0 0 0 0
C 1 13 0 0 0 0 0 0
E 1 33 0 0 0 0 0 0
Hemorrhage HEMORRHAGE B 0 0 0 0 2 10 0 0
C 1 13 1 13 0 0 0 0
E 0 0 0 0 0 0 0 0
Hepatic SGOT (AST) B 8 40 0 0 0 0 0 0
C 4 50 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
SGPT (ALT) B 2 10 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
ALK PHOS B 1 5 0 0 0 0 0 0
C 3 38 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPOALBUMINEMIA B 1 5 1 5 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
BILIRUBIN B 2 10 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Infection/Febrile Neutropenia INFECTION-NO ANC B 2 10 2 10 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Metabolic/Laboratory HYPOCALCEMIA B 5 25 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPONATREMIA B 1 5 0 0 1 5 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPERURICEMIA B 0 0 0 0 1 5 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPOPHOSPHATEMIA B 2 10 2 10 0 0 0 0
CNS NCCTG CNS Committee N0272 - Page 7 of 9
NCCTG Status Report for Study N0272 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 0 0 1 13 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPERMAGNESEMIA B 1 5 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPOMAGNESEMIA B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
HYPERGLYCEMIA B 8 40 1 5 0 0 0 0
C 5 63 0 0 0 0 0 0
E 1 33 0 0 0 0 0 0
METABOLIC/LAB B 1 5 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Neurology INSOMNIA B 2 10 1 5 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
SEIZURE B 0 0 0 0 3 15 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
DIZZINESS B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
SPEECH B 0 0 1 5 1 5 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
LOW CONSCIOUSNESS B 1 5 2 10 0 0 0 0
C 0 0 1 13 0 0 0 0
E 0 0 0 0 0 0 0 0
DEPRESSION B 1 5 0 0 1 5 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
ATAXIA B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
PERSONALITY CHANGE B 0 0 0 0 1 5 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NEURO-SENSORY B 3 15 1 5 0 0 0 0
CNS NCCTG CNS Committee N0272 - Page 8 of 9
NCCTG Status Report for Study N0272 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
C 2 25 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NEURO-MOTOR B 2 10 2 10 1 5 0 0
C 2 25 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NEURO-CRANIAL B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
NEURO B 1 5 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Ocular/Visular VISION-PHOTOPHOBIA B 0 0 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
VISION-BLURRED B 1 5 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
VISION B 3 15 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Pain HEADACHE B 2 10 1 5 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
MYALGIA B 4 20 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
PAIN-ABDOMINAL B 2 10 0 0 0 0 0 0
C 1 13 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Pulmonary DYSPNEA B 1 5 0 0 1 5 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Renal /Genitourinary URINARY FREQUENCY B 2 10 0 0 0 0 0 0
C 0 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0 0
Maximum Grade Adverse Event B 7 35 6 30 6 30 1 5
C 5 63 3 38 0 0 0 0
E 3 100 0 0 0 0 0 0
CNS NCCTG CNS Committee N0272 - Page 9 of 9
NCCTG Status Report for Study N027D - September 2007
A Phase I Study of CCI-779 and Temozolomide in Combination with Radia-
tion Therapy in Glioblastoma Multiforme
Purpose of - Goal: Treatment
Study: 1) To determine the MTD of weekly IV CCI-779 combined with daily oral
TMZ and 3D-conformal RT or IMRT followed by weekly IV CCI-779 com-
bined with adjuvant oral TMZ.
2) To assess and describe the adverse events of the combination of CCI-779/
TMZ and radiation followed by the combination of adjuvant CCI-779/TMZ.
3) To evaluate for early response to therapy with an automated morphological
MRI change detector and with physiological MR imaging techniques
including diffusion-weighted imaging, perfusion-weighted imaging, and
chemical shift imaging.
- Translational
1) Determine the inhibition status of mTOR signaling pathways in PBMC fol-
lowing weekly dosing with CI-779 in all patients treated on trial.
2) Identify potential pharmacokinetic interactions between TMZ and intrave-
nous CCI-779.
3) Preliminarily assess the relationship between efficacy endpoints (survival,
progression-free survival, response) and pre-treatment tumor tissue molecu-
lar markers.
Study Chairs: Jann N. Sarkaria M.D. QC Specialist: Butch K. Kvittem CCRP
Evanthia Galanis M.D.
John B. Fiveash M.D.
Statistician: Wenting Wu Ph.D. Nurse Resource: Beverly L Kowbel
Status: 05/12/2006 Activated Projected Number of Patients: 46
Excluded: None Final Accrual: NA
Stratification
Factors:
Schema: Pre-registration
Registration
CCI-779 + RT + TMZ followed by CCI-779 + TMZ
Treating Schedule:
Arm Agent Dose Route Days Freq
* CCI-779 Assigned by Ran- IV Weekly 7 weeks
dom
* TMZ Assigned by Ran- Oral Daily 7 days/week for 6 weeks
dom
CNS NCCTG CNS Committee N027D - Page 1 of 5
NCCTG Status Report for Study N027D - September 2007
Arm Agent Dose Route Days Freq
+ CCI-779 Assigned by Ran- IV 1, 8, 15, and 22 Every 28 days for 6 cycles
dom
+ TMZ 200 mglm2/d Oral 1-5 Every 28 days for 6 cycles
Arm Dose Days FX/Day FX/Size # FX RT Length
I 5000 cGy M-F 1 200 cGy 25 5 weeks
B 1000 cGy M-F 1 200 cGy 5 1 week
I=Initial RT fields
B=Boost RT fields
* Concomitant treatment with CCI-779. CCI-779 start 7-10 days prior
to RT and TMZ.
+ Adjuvant treatment with CCI-779 and TMZ for 6 cycles.
Radiation Quality Control Report
Eligible cases entered & reviewed as of 6/07
Total cases: 4
% minor deviations: 25.0
% major deviations: 0.0
Study Design: This is a Phase I protocol that will evaluate weekly IV CCI-779 combined with
daily oral TMZ and RT followed by weekly IV CCI-779 combined with adjuvant TMZ for
newly diagnosed GBM patients. The trial will use a standard cohort-of-3 Phase I design. The
aim is to determine the MTD of CCI-779 combined with therapeutic doses of TMZ and RT fol-
lowed by CCI-779 combined with a therapeutic dose of TMZ as adjuvant therapy following RT.
CCI-779 will not be escalated above its single agent established MTD. Only CCI-779 will be
escalated and the same dose of CCI-779 will be used in the adjuvant phase as is used for con-
comitant therapy with TMZ and RT.
Accrual: This study was activated on 5/12/2006. As of 8/13/2007, 10 patients have been
enrolled at Mayo. The study is currently open to enrollment at dose level 2.
Patient Characteristics: Available baseline information is summarized in the Baseline Charac-
teristics Table below. The 10 patients are 8 male (80%) and 2 female (20%) ranging in age from
47 to 69 (median age=59). No one is classified as a minority.
CNS NCCTG CNS Committee N027D - Page 2 of 5
NCCTG Status Report for Study N027D - September 2007
Available Information: As of 8/13/2007, 8 patients are alive with 4 still on-study. No patients
have been declared ineligible. There is one patient on dose level 2 that has been replaced. All
10 patients have response data available.
Adverse Events: With Adverse Event information available for all 10 patients (see Adverse
Events Table below), one grade 5 adverse event (gastric infection) has been reported in 1
replaced patient. Two grade 4 adverse events have been seen in 2 patients (pneumonia and
thrombosis), which were considered to be treatment related. One DLT has been seen (failure to
administer >75% of study drug) at dose level 2.
Study Status: The study is reopened to enrollment at dose level 2 on 7/13/2007.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Mayo 10 3 7
Total Membership Accrual 10 3 7
Baseline Characteristics Table:
Arm
Characteristics
A
Age Group
40-60 7
>60 3
Contrast Enhancement
Yes 9
No 1
Corticosteroid Therapy
Yes 2
No 8
Extent Resection
Biopsy 2
Subtotal Resection 4
Gross Total Resection 3
Unknown 1
Frozen Cells
Yes 1
No 9
Gender
Female 2
CNS NCCTG CNS Committee N027D - Page 3 of 5
NCCTG Status Report for Study N027D - September 2007
Arm
Characteristics
A
Male 8
History Brain
No 10
Paraffin Tissue
Yes 10
Performance Score
0 2
1 8
Race
White 10
Side Primary
Right 4
Left 5
Unknown 1
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 9
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 5 56 2 22 0 0 0 0
LEUKOPENIA A 2 22 3 33 0 0 0 0
ANEMIA A 7 78 0 0 0 0 0 0
THROMBOCYTOPENIA A 5 56 3 33 0 0 0 0
Auditory/Hearing OTITIS EXTERNAL A 1 11 0 0 0 0 0 0
Cardiovascular THROMBOSIS A 0 0 0 0 1 11 0 0
Constitutional Symptoms FATIGUE A 8 89 1 11 0 0 0 0
WEIGHT LOSS A 2 22 0 0 0 0 0 0
Dermatology/Skin ALOPECIA A 5 56 0 0 0 0 0 0
DRY SKIN A 1 11 0 0 0 0 0 0
NAIL CHANGES A 2 22 0 0 0 0 0 0
RASH A 7 78 0 0 0 0 0 0
DERMATITIS-RT A 3 33 0 0 0 0 0 0
PRURITUS A 2 22 0 0 0 0 0 0
Gastrointestinal ANOREXIA A 3 33 0 0 0 0 0 0
NAUSEA A 5 56 0 0 0 0 0 0
STOMATITIS A 4 44 0 0 0 0 0 0
TASTE A 1 11 0 0 0 0 0 0
MOUTH DRYNESS A 1 11 0 0 0 0 0 0
VOMITING A 1 11 1 11 0 0 0 0
CNS NCCTG CNS Committee N027D - Page 4 of 5
NCCTG Status Report for Study N027D - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
DIARRHEA-NO COLOSTOM A 2 22 0 0 0 0 0 0
Hepatic SGOT (AST) A 6 67 1 11 0 0 0 0
BILIRUBIN A 1 11 0 0 0 0 0 0
Infection/Febrile Neutropenia PNEUMONIA NOS A 0 0 0 0 1 11 0 0
GASTRIC INFECTN A 0 0 0 0 0 0 1 11
Metabolic/Laboratory HYPERCHOLESTEROLEMI A 6 67 2 22 0 0 0 0
HYPERCALCEMIA A 2 22 0 0 0 0 0 0
HYPOCALCEMIA A 4 44 0 0 0 0 0 0
HYPERMATREMIA A 1 11 0 0 0 0 0 0
HYPONATREMIA A 2 22 0 0 0 0 0 0
HYPERKALEMIA A 1 11 0 0 0 0 0 0
HYPOKALEMIA A 2 22 0 0 0 0 0 0
HYPERTRIGLYCERIDEMIA A 6 67 2 22 0 0 0 0
HYPERGLYCEMIA A 2 22 2 22 0 0 0 0
ALK PHOSPHATASE A 2 22 0 0 0 0 0 0
Musculoskeletal MUSCLE WEAKNESS A 2 22 1 11 0 0 0 0
LWR EXTREM WKNS A 0 0 1 11 0 0 0 0
Neurology DEPRESSION A 1 11 0 0 0 0 0 0
ATAXIA A 1 11 0 0 0 0 0 0
CONFUSION STATE A 0 0 1 11 0 0 0 0
Ocular/Visular DRY EYE A 1 11 0 0 0 0 0 0
Pulmonary COUGH A 1 11 1 11 0 0 0 0
DYSPNEA A 2 22 1 11 0 0 0 0
Renal /Genitourinary CREATININE A 1 11 0 0 0 0 0 0
Maximum Grade Adverse Event A 1 11 5 56 2 22 1 11
CNS NCCTG CNS Committee N027D - Page 5 of 5
NCCTG Status Report for Study N047B - September 2007
A Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Patients with
Recurrent Glioblastoma
Purpose of - Treatment
Study: 1) To identify any clinical efficacy of SAHA in the treatment of recurrent glio-
blastoma, as measured by 6 month progression-free survival.
2) To assess the safety and toxicity of SAHA in this patient population.
.
- Translational Research
1) To assess SAHA pharmacokinetics in glioblastoma patients.
2) To study the biologic effects of SAHA in target tissues, including primary
tumors and to assess the association between genetic alterations in tumors
and response to treatment.
Study Chairs: Evanthia Galanis M.D. QC Specialist: Butch K. Kvittem CCRP
John F. Schwerkoske M.D.
Statistician: Matthew J. Maurer M.S. Nurse Resource: Beverly L Kowbel
Status: 09/16/2005 Activated Projected Number of Patients: 100
Excluded: 2 Final Accrual: NA
Stratification None
Factors:
Schema: Reg
Groups 1 and 3
SAHA
PD
Event Monitoring
Group 2
SAHA
Surgery
Recovery
SAHA
PD
Event Monitoring
Treating Schedule:
Arm Agent Dose Route Days Freq
SAHA 200 mg BID 3 days prior to sur- 1 dose d 1;2 doses d2; 2 doses d 3;
gery 1 dose morn of surgery
SAHA 200 mg BID 2 weeks treatment Every 3 weeks
/ 1 week rest
CNS NCCTG CNS Committee N047B - Page 1 of 6
NCCTG Status Report for Study N047B - September 2007
Study Design: This protocol will assess the percentage of patients being progression free at 6
months and toxicites associated with SAHA in patients with recurrent glioblastoma multiforme
(GBM) using a one-stage phase II study design with interim analysis. This regimen will be con-
sidered active in this population if at least 9 of the first 52 evaluable (eligible and received treat-
ment) patients are alive and progression free 6 months after entering the study. An interim
analysis will be performed after the first 22 evaluable patients have been enrolled and followed
for six months. In addition, patients receiving SAHA prior to surgery on study (group 2) and
patients who have received more than one prior regimen for recurrent disease (group 3) may be
enrolled to the study, though not used in the formal efficacy analysis above.
Accrual: As of 8/06/2007, there have been 93 patients enrolled: 68 on Group 1 (not undergoing
surgery with 1 or none prior chemotherapy regimens), 10 on Group 2 (undergoing surgery and
receiving pre-surgery SAHA) and 15 on Group 3 (not undergoing surgery with 2 or more prior
chemotherapy regimens). Group 1 has met accrual and permanently closed on 10/27/2006. Two
patients on Group 1 are cancellations. Groups 2 and 3 remain open to accrual.
Patient Characteristics: Available baseline information is summarized in the Baseline Charac-
teristics Table below.
Available Information: As of 8/06/2007, onstudy information is available for all patients. At
this time, 66 patients have died.
Adverse Events: Adverse Event information is available for 88 patients: 66 in Group 1, 7 in
Group 2, and 14 in Group 3.
Group 2: Grade 3+ adverse events have consisted of one patient with grade 3 fatigue probably
related to treatment and grade 4 hydrocephalus and CNS necrosis, both unlikely to be related to
treatment; one patient with grade 3 dehydration, nausea, and vomiting, all probably related to
treatment and grade 4 headache, unlikely to be related to study treatment; and one patient with
grade 4 headache,considered not related to study treatment.
Groups 1 & 3: Three grade 5 events have been reported; one pneumonia possibly related to
treatment and two disease progressions unrelated to treatment. There have been 17 patients with
grade 4+ events (any attribution).
There have been 5/80 (6%) patients with grade 4+ treatment-related non-heme toxicities: bron-
chitis (possible gr 4), fatigue/hemorrhage (both possible gr 4), confusion/fatigue (both possible
gr 4), hypokalemia (possible gr 4), fatigue (definite gr 4)/pneumonia (possible gr 5). There have
been 8/80 (6%) patients with at least one grade 4+ treatment related heme toxicities: 7 patients
reported only thrombocytopenia grade 4 (6 of these probable, 1 definite), 1 patient reported
thrombocytopenia, leukopenia and neutropenia grade 4, problably related to study treatment.
CNS NCCTG CNS Committee N047B - Page 2 of 6
NCCTG Status Report for Study N047B - September 2007
Adverse events regardless of attribution are summarized in the Adverse Event Table below.
Additional Information: The study has been amended to discontinue dose escalation to 300
mg bid.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Carle 3 0 1
Cedar Rapids 1 0 1
Des Moines 5 0 2
Duluth 2 0 1
Fargo 6 1 2
Hawaii CCOP 1 0 1
Jacksonville 11 0 1
Lehigh 1 1 1
Mayo 43 3 10
Metro MN 5 1 1
Oklahoma 2 0 0
Peoria 2 0 1
Sioux City 1 0 0
St. Cloud 1 1 1
Upstate Carol 3 0 1
Wichita 6 0 2
Total Membership Accrual 93 7 26
Baseline Characteristics Table:
Arm
Characteristics
A
Age Group
60 33
Anticonvulsants
Yes 28
No 65
Corticosteroid Therapy
Yes 66
No 27
Extent Recurrence Resection
None 62
Biopsy 2
Subtotal Resection 18
Gross Total Resection 11
CNS NCCTG CNS Committee N047B - Page 3 of 6
NCCTG Status Report for Study N047B - September 2007
Arm
Characteristics
A
Extent Resection
None 1
Biopsy 16
Subtotal Resection 38
Gross Total Resection 38
Gender
f 39
m 54
History Brain
Yes 6
No 87
Num Prior Chemo
0 38
1 40
2 11
3 3
5 1
Performance Score
0 14
1 54
2 25
Prior Nitrosoureas
Yes 20
No 73
Race
White 90
Black or African American 1
Not reported: patient refused or not ava 2
CNS NCCTG CNS Committee N047B - Page 4 of 6
NCCTG Status Report for Study N047B - September 2007
Grade 4/5 and Most Frequent Adverse Event Table
Group 1 Evaluable Patients: 66
Group 2 Evaluable Patients: 8
Group 3 Evaluable Patients: 14
N %
Patients with at least one: Arm
Grade 3+ Adverse Event 1 42 63.6
2 3 37.5
3 8 57.1
Grade 4+ Adverse Event 1 14 21.2
2 3 37.5
3 3 21.4
Grade 3+ Hem Adverse Event 1 18 27.3
3 3 21.4
Grade 4+ Hem Adverse Event 1 7 10.6
3 1 7.1
Grade 3+ Non-Hem Adverse Event 1 34 51.5
2 3 37.5
3 7 50.0
Grade 4+ Non-Hem Adverse Event 1 9 13.6
2 3 37.5
3 2 14.3
Maximum Severity Per Patient
Adverse
Group Grade 1 Grade 2 Grade 3 Grade 4 Grade 5
Event
N % N % N % N % N %
FATIGUE 1
19 28.8 4 37.9 10 15.2 3 4.5
2
3 37.5 1 12.5 1 12.5
3
6 42.9 4 28.6 2 14.3
THROMBOCYTOPENIA 1
27 40.9 6 9.1 7 10.6 7 10.6
2
4 50.0 1 12.5
3
9 64.3 1 7.1 2 14.3 1 7.1
ANEMIA 1
27 40.9 5 7.6 2 3.0
2
3 37.5
3
7 50.0 1 7.1
LEUKOPENIA 1
11 16.7 14 21.2 1 1.5 1 1.5
2
2 25.0 1 12.5
3
1 7.1 3 21.4 1 7.1
DIARRHEA-NO 1
17 25.8 3 4.5 2 3.0
COLOSTOM 2
2 25.0
3
6 42.9 1 7.1
NEUTROPENIA 1
9 13.6 8 12.1 4 6.1 1 1.5
2
3 37.5 1 12.5
3
3 21.4 2 14.3
NAUSEA 1
15 22.7 1 1.5 1 1.5
2
3 37.5 1 12.5 1 12.5
3
5 35.7 1 7.1
CNS NCCTG CNS Committee N047B - Page 5 of 6
NCCTG Status Report for Study N047B - September 2007
ANOREXIA 1
8 12.1 7 10.6 2 3.0
2
1 12.5
3
5 35.7 1 7.1
HYPERGLYCEMIA 1
8 12.1 4 6.1 9 13.6
3
2 14.3
TASTE 1
10 15.2 5 7.6
2
1 12.5
3
3 21.4
PAIN-HEADACHE 1
4 6.1 3 4.5 4 6.1
2
2 25.0
3
1 7.1 1 7.1
SGOT (AST) 1
8 12.1 3 4.5
2
1 12.5
3
1 7.1 2 14.3
PAIN-ABDOMINAL 1
10 15.2 1 1.5 1 1.5
2
1 12.5
MUSCLE WEAKNESS 1
1 1.5 2 3.0 4 6.1
3
3 21.4
ALK PHOSPHATASE 1
6 9.1 1 1.5
3
1 7.1 1 7.1
THROMBOSIS 1
4 6.1 2 3.0
3
1 7.1
CONFUSION STATE 1
2 3.0 2 3.0 1 1.5
3
1 7.1
SEIZURE 1
1 1.5 2 3.0 1 1.5
3
1 7.1 1 7.1
NEURO-MOTOR 1
1 1.5 1 1.5 1 1.5
3
1 7.1
PNEUMONIA 1
2 3.0 1 1.5
DISEASE PROGRESSION 1
1 1.5
3
1 7.1
GAIT ABN NOS 1
1 1.5 1 1.5
HEMORRHAGE-CNS 1
2 3.0
HYDROCEPHALUS 1
1 1.5
2
1 12.5
HYPOKALEMIA 1
1 1.5 1 1.5
PNEUMONIA NOS 1
1 1.5 1 1.5
BRONCHITIS NOS 1
1 1.5
CD4 COUNT 1
1 1.5
CNS NECR 2
1 12.5
CNS NCCTG CNS Committee N047B - Page 6 of 6
NCCTG Status Report for Study N0572 - September 2007
A Phase I/II Trial of Sorafenib and CCI-779 in Patients with Recurrent Glio-
blastoma
Purpose of * Phase I
Study: 1) To establish a maximum tolerable dose of CCI-779 in combination with sor-
afenib in patients not receiving EIACs.
2) To define the safety profile of CCI-779 and sorafenib in patients not receiv-
ing EIACs.
3) To assess the evidence of antitumor activity.
* Phase II
1) To assess the efficacy of CCI-779 and sorafenib in the treatment of recurrent
glioblastoma in patients not receiving EIACs as measured by progression-
free survival.
2) To assess the safety and toxicities of CCI-779 and sorafenib in the above-
noted patient populations.
* Translational
1) To determine the relationship between tumor and blood biomarkers and
clinical outcome of patients treated with the combination of targeted agents.
2) To evaluate tumor tissue specimens for evidence of bioactivity of these
agents; data from this portion of the study will be descriptive and for
hypothesis generation.
Study Chairs: Kurt A. Jaeckle M.D. QC Specialist: Butch K. Kvittem CCRP
David Schiff M.D.
Statistician: Paul Decker Nurse Resource: Beverly L Kowbel
Status: 03/24/2006 Activated Projected Number of Patients: 96
Excluded: None Final Accrual: NA
Stratification Phase I: non-surgical patients only
Factors: Phase II: Patients not undergoing surgery following study drug exposure
vs. patients undergoing surgery following study drug exposure
Schema: Phase I
Pre-Registration
Registration
A) Assigned dose Sorafenib days 1-28 + Assigned Dose CCI-779 d
1,8,15,22
Phase II
B) No Surgery: Sorafenib + CCI-779
C) Surgery: Pre-surgery Sorafenib + CCI-779
Surgery on day 8 + Recovery
CNS NCCTG CNS Committee N0572 - Page 1 of 5
NCCTG Status Report for Study N0572 - September 2007
Sorafenib days 1-28 + CCI-779 d 1,8,15,22
Treating Schedule:
Arm Agent Dose Route Days Freq
A Sorafenib As assigned p.o. b.i.d. 1-28 28 days (4 weeks)
A CCI-779 As assigned IV over 30 minutes 1, 8, 15, 22 28 days (4 weeks)
B Sorafenib TBD (to be deter- p.o. b.i.d. 1-28 28 days (4 weeks)
mined by Arm A)
B CCI-779 TBD (to be deter- IV over 30 minutes 1, 8, 15, 22 28 days (4 weeks)
mined by Arm A)
C Sorafenib TBD p.o. b.i.d. 15 doses, days 1-8 28 days (4 weeks)
presurgery; days 1-
28 post surgery
C CCI-779 TBD IV over 30 minutes Day 1 presurgery; 28 days (4 weeks)
days 1, 8, 15, 22
post surgery
Arm C includes surgery on day 8.
Study Design: This is a phase I/II study of CCI-779 in combination with Sorafenib in patients
with recurrent glioblastoma not on EIACs. Study 1 is a Phase I cohorts-of-3+3 design that will
determine a tolerable dose of CCI-779 (not beyond 250 mg) in combination with Sorafenib (200
mg or 400 mg bid) for non-EIAC patients. Study 2 is a single-stage Phase II trial designed a) to
assess the efficacy of CCI-779 and Sorafenib by progression-free survival in the treatment of
recurrent glioblastoma in patients not receiving EIAC, and b) to assess the safety and toxicities
of CCI-779 and Sorafenib in recurrent glioblastoma non-EIAC patients. Study 2 has one planned
interim analysis after the 19th evaluable patient has been followed for 6 months.
Accrual: The study opened to NCCTG on March 24th, 2006. As of August 8,2007, 12 patients
from 6 memberships have been enrolled to study 1 (with three being replaced for MTD determi-
nation). Accrual by membership is summarized in the Accrual Table below.
Patient Characteristics: The 12 patients in study 1 are 6 males and 6 females with median age
being 52 years old.
Available Information: As of August 8, 2007, in study 1, 3 patients are alive and 1 is still on
study.
Adverse Events: Adverse Event information is available for 12 patients in study 1. Please see
Adverse Event table below.
CNS NCCTG CNS Committee N0572 - Page 2 of 5
NCCTG Status Report for Study N0572 - September 2007
Study Status: Study 1 is currently open to non-EIAC patients with recurrent glioblastoma.
Study 2 will open after study 1 has been completed and analyzed.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Carle 1 0 0
Cedar Rapids 3 2 3
Fargo 1 0 1
Jacksonville 1 1 1
Mayo 4 0 1
Wichita 2 1 2
Total Membership Accrual 12 4 8
Baseline Characteristics Table:
Arm Arm Arm
Characteristics
A B C
Age Group
60 4 0 0
Anticonvulsants
Yes 4 0 0
No 8 0 0
Corticosteroid Therapy
Yes 7 0 0
No 5 0 0
Extent Recurrence Resection
None 9 0 0
Biopsy 1 0 0
Subtotal Resection 1 0 0
Gross Total Resection 1 0 0
Extent Resection
Biopsy 2 0 0
Subtotal Resection 6 0 0
Gross Total Resection 4 0 0
Gender
f 6 0 0
m 6 0 0
Group
CNS NCCTG CNS Committee N0572 - Page 3 of 5
NCCTG Status Report for Study N0572 - September 2007
Arm Arm Arm
Characteristics
A B C
PhI Non-Surgical 12 0 0
Performance Score
0 3 0 0
1 6 0 0
2 3 0 0
Prior Nitrosoureas
Yes 2 0 0
No 10 0 0
Prior Therapy
Yes 11 0 0
No 1 0 0
Race
White 12 0 0
Interval since end of RT, months
4 2 0 0
5 1 0 0
6 1 0 0
9 1 0 0
10 2 0 0
11 1 0 0
13 1 0 0
17 1 0 0
25 1 0 0
57 1 0 0
Tumor Type
MEASURABLE 7 0 0
EVALUABLE 5 0 0
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 12
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 5 42 0 0 0 0 0 0
LEUKOPENIA A 3 25 1 8 0 0 0 0
ANEMIA A 9 75 0 0 0 0 0 0
THROMBOCYTOPENIA A 7 58 0 0 0 0 0 0
Constitutional Symptoms FATIGUE A 7 58 4 33 0 0 0 0
Dermatology/Skin DRY SKIN A 2 17 0 0 0 0 0 0
SKIN RXN-HAND/FOOT A 3 25 0 0 0 0 0 0
CNS NCCTG CNS Committee N0572 - Page 4 of 5
NCCTG Status Report for Study N0572 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
RASH A 7 58 1 8 0 0 0 0
Gastrointestinal ANOREXIA A 1 8 1 8 0 0 0 0
NAUSEA A 2 17 1 8 0 0 0 0
STOMATITIS A 2 17 0 0 0 0 0 0
TASTE A 4 33 0 0 0 0 0 0
VOMITING A 2 17 1 8 0 0 0 0
DIARRHEA-NO COLOSTOM A 5 42 0 0 0 0 0 0
COLONIC PERF A 0 0 0 0 1 8 0 0
Hepatic SGOT (AST) A 3 25 0 0 0 0 0 0
SGPT (ALT) A 2 17 0 0 0 0 0 0
Metabolic/Laboratory HYPERCHOLESTEROLEMI A 7 58 1 8 0 0 0 0
HYPOCALCEMIA A 3 25 0 0 0 0 0 0
HYPOKALEMIA A 1 8 3 25 0 0 0 0
HYPERTRIGLYCERIDEMIA A 8 67 0 0 0 0 0 0
HYPOPHOSPHATEMIA A 1 8 3 25 0 0 0 0
HYPERGLYCEMIA A 0 0 2 17 0 0 0 0
Musculoskeletal MUSCLE WEAKNESS A 0 0 2 17 0 0 0 0
Pain PAIN-ABDOMINAL A 6 50 0 0 0 0 0 0
Maximum Grade Adverse Event A 4 33 7 58 1 8 0 0
CNS NCCTG CNS Committee N0572 - Page 5 of 5
NCCTG Status Report for Study N0574 - September 2007
A Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy
in Addition to Radiosurgery in the Management of Patients with One to Three
Cerebral Metastases - pre registration
Purpose of - Primary Objective
Study: 1) To ascertain in patients with one to three brain metastases whether there is
equal (or better) overall survival in patients who receive SRS alone (Arm 1)
compared to patients who receive SRS combined with WBRT (Arm 2).
.
- Secondary Objectives
1) To ascertain in patients with one to three brain metastases whether there is
equal (or greater) time to central nervous system (CNS) failure (brain) in
patients who receive SRS alone (Arm 1) compared to patients who receive
SRS combined with WBRT (Arm 2).
2) To ascertain in patients with one to three brain metastases whether there is
improved QOL in patients who receive SRS alone (Arm 1) compared to
patients who receive SRS combined with WBRT (Arm 2).
3) To ascertain in patients with one to three brain metastases whether there is
longer duration of functional independence in patients who receive SRS
alone (Arm 1) compared to patients who receive SRS combined with WBRT
(Arm 2).
4) To ascertain in patients with one to three brain metastases whether there is
better long-term neurocognitive status in patients who receive SRS alone
(Arm 1) compared to patients who receive SRS combined with WBRT (Arm
2).
5) To tabulate and descriptively compare the post-treatment adverse events
associated with the interventions.
Study Chairs: Paul D. Brown M.D. QC Specialist: Butch K. Kvittem CCRP
Statistician: Karla V. Ballman Ph.D. Nurse Resource: Beverly L Kowbel
Status: 07/28/2006 Activated Projected Number of Patients: 458
Excluded: None Final Accrual: NA
Stratification None
Schema: Randomize
Arm 1: RS
Arm 2: RS + WBRT
Follow-up
Treating Schedule:
No treatment information
CNS NCCTG CNS Committee N0574 - Page 1 of 3
NCCTG Status Report for Study N0574 - September 2007
Study Design: This protocol is meant to be a continuation of the ACOSOG trial Z0300. Data
for the 70 patients already accrued to Z0300 will be included in the final accrual and analysis for
this study. This a randomized Phase III equivalency trial and will use an intent-to-treat analysis.
Three formal interim analyses will be performed at the time at which 25%, 50%, and 75% of the
projected number of events have occurred.
Accrual: Accrual information for the patients accrued under ACOSOG Z0300 can be found on
the ACOSOG Study Z0300 report. At the time of this report, 8/06/2007, seven patients have
been enrolled, 5 through NCCTG and 2 through CTSU.
Patient Characteristics: Available baseline information for the seven patients enrolled through
NCCTG is summarized in the Baseline Characteristics Table below. Available baseline informa-
tion for patients accrued under the ACOSOG study can be found in the ACOSOG Report of
Studies (Study Z0300).
Available Information: As if 8/06/2007, randomization information is available for all
patients, but only one patient is fully evaluable.
Adverse Events: Adverse Event information is available for 3 patients only. All grade 4 and 5
reported AEs regardless of attribution and the most frequent grade 1, 2 and 3 AEs are summa-
rized in the Adverse Events Table below. There was one Grade 5 event (thrombosis), which was
deemed unrelated to protocol treatment. Data for patients previously enrolled in Study Z0300
can be found in the ACOSOG Report of Studies.
Study Status: This study was formally led by ACOSOG (Study Z0300). Due to restructuring at
ACOSOG, the study was closed and NCCTG has assumed the lead group role. Data collected
from the ACOSOG trial will be transferred to NCCTG. The trial was opened through NCCTG
on 7/28/2006.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Atlanta 1 1 1
Geisinger 1 1 1
Mayo 3 3 3
Total Membership Accrual 5 5 5
CNS NCCTG CNS Committee N0574 - Page 2 of 3
NCCTG Status Report for Study N0574 - September 2007
Randomizing Total Past 6 Past 12
Group Entered Months Months
NCCTG 5 5 5
CTSU 2 2 2
Total Group Accrual 7 7 7
Baseline Characteristics Table:
Arm Arm
Characteristics
A B
Age Group
1 1 2
2 2 2
Disease Controlled (mo.)
1 3 4
Gender
f 3 1
m 0 3
Number of Brain Mets
1 2 1
2 1 3
Race
White 3 3
Black or African American 0 1
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 1
Arm B Evaluable Patients: 2
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology LYMPHOPENIA A 0 0 1 100 0 0 0 0
B 0 0 0 0 0 0 0 0
ANEMIA A 0 0 1 100 0 0 0 0
B 0 0 0 0 0 0 0 0
Cardiovascular THROMBOSIS A 0 0 0 0 0 0 1 100
B 0 0 0 0 0 0 0 0
Dermatology/Skin ALOPECIA A 0 0 0 0 0 0 0 0
B 1 50 0 0 0 0 0 0
Gastrointestinal NAUSEA A 0 0 0 0 0 0 0 0
B 1 50 0 0 0 0 0 0
Maximum Grade Adverse Event A 0 0 0 0 0 0 1 100
B 2 100 0 0 0 0 0 0
CNS NCCTG CNS Committee N0574 - Page 3 of 3
NCCTG Status Report for Study N0477 - September 2007
Optimizing EGFR Inhibitor-Based Therapies for GBM
Purpose of - Primary Aim:
Study: 1) Identify molecular characteristics that predict for overall survival and pro-
gression-free survival endpoints for patients treated with erlotinib, temozo-
lomide and radiation for patients enrolled on the NCCTG trial N0177.
- Secondary Aim:
1) Identify molecular characteristics that predict for overall survival and pro-
gression-free survival endpoints for patients treated with gefitinib following
radiation for patients enrolled on the NCCTG trial N0074.
Study Chairs: Jann N. Sarkaria M.D. QC Specialist:
Statistician: Karla V. Ballman Ph.D. Nurse Resource:
Status: 11/24/2006 Activated Projected Number of Patients: 240
Excluded: None Final Accrual: NA
Stratification
Factors:
Schema: Register
Treating Schedule:
No treatment information
Accrual: As of August 6, 2007, there are 19 patients (from the 98 accrued) from study N0074,
and 9 patients (from the 141 accrued) from study N0177 included in this database study.
For patient characteristics and adverse event information please refer to the respective Book
Reports of N0074 and N0177.
CNS NCCTG CNS Committee N0477 - Page 1 of 1
NCCTG Status Report for Other Closed CNS Trials - September 2007
937252 * Phase III Trial of BCNU and Cisplatin Versus BCNU Alone and Stan-
dardRadiation Therapy Versus Accelerated Radiation Therapy in Patients
With Grade 4 Glioma
* Closed: 06/18/1999
* Final accrual data appeared in the Spring 2002 NCCTG book.
* Final adverse event summary appeared in the Spring 2003 NCCTG book.
* ASCO abstract appeared in the Spring 2001 NCCTG book.
* An abstract reporting on the observed ototoxicity of cisplatin (CDDP)
plus standard radiation therapy (SRT) versus accelerated radiation
therapy (ART) in glioblastoma (GBM) patients was presented at the
Society of Neuro-oncology November 2003 meeting. (Abstract RT-07)
Reference: Neuro-Oncology 2003 Oct; 5(4):344.
* A manuscript reporting on the observed ototoxicity of
CDDP plus SRT versus ART in GBM patients was published in the Journal
of Neuro-Oncology (November 5, 2005: 1-6).
* A manuscript summarizing the efficacy results has been published:
Journal of Clinical Oncology 2006, v. 24, n. 24, pp 3871-3879.
937351 * Phase II Trial of Chemotherapy Plus Radiotherapy for Management ofPri-
mary Central Nervous System Non-HodgkinsLymphoma(PCNSL)'
* Closed: 09/27/2000
* Final accrual information appeared in the Spring 2002 NCCTG book.
* Final adverse event summary appeared in the Spring 2003 NCCTG book.
* ASCO abstract appeared in the Spring 2002 NCCTG book.
* The abstract presented at the 2002 Society of Neuro-Oncology meeting
appeared in the Spring 2003 NCCTG book.
* A manuscript summarizing the efficacy results is under revision.
987252 * A Phase II Trial of Preirradiation Chemotherapy With BCNU, Cisplatin,and
Oral Etoposide Combined With Radiation Therapy in the Treatment of
Grade 4 Astrocytoma (Glioblastoma)
* Closed: 08/18/2000
* Final accrual summary appeared in the Spring 2002 NCCTG book.
* Final adverse event summary appeared in the Spring 2002 NCCTG book.
* ASCO abstract appeared in the Spring 2002 NCCTG book.
* Manuscript status: in progress
* See 987251 for status of QOL data.
N0074 * Phase II Study of ZD1839 (NSC 715055) in Newly Diagnosed Patients
withGlioblastoma (Grade 4 Astrocytoma)
* Closed: 08/02/2002
* Final accrual information is available in the Spring 2005 NCCTG book.
* The final adverse event summary is available in the Spring 2005 NCCTG
CNS NCCTG CNS Committee Other Closed Trials - Page 1 of 2
NCCTG Status Report for Other Closed CNS Trials - September 2007
book.
* The efficacy results for this trial were presented at the 2004 ASCO
meeting. Journal of Clinical Oncology 2004, 22(14S), p 1505.
* QOL baseline/on-study data: a poster was presented at the 2003 Society
of Neuro-Oncology conference and the manuscript has been published in
the Journal of Neuro-Oncology (September 5, 2005).
* QOL changes over time: A poster was presented at the 2004 ASCO
conference. A manuscript has been published in Neurosurgery (Sep 2005,
57: 495-504).
* A final analysis has been completed and a manuscript is being
prepared.
N997D * Pilot and Phase II Trial of Irinotecan and Radiation Followed byIrinotecan
and BCNU in Glioblastoma Multiforme Patients
* Closed: 02/03/2006
* Final accrual information is available in the Fall 2006 NCCTG book.
* The final adverse event summary is available in the Fall 2006 NCCTG
book.
* The efficacy results for this trial were presented at the 2005 ASCO
annual meeting. Journal of Clinical Oncology 2005, 20(18S), 1562.
* A final analysis has been completed and a manuscript is being
prepared.
CNS NCCTG CNS Committee Other Closed Trials - Page 2 of 2
Protocol Concepts for CNS - September 2007
N0577 Phase III Study of Radiotherapy With or Without Concomitant andAdju-
vant Temozolomide in Newly Diagnosed Anaplastic OligodendrogliomaPa-
tients with 1p and/or19q gene deletions and Phase II Study ofRadiotherapy
with Concomitant and Adjuvant Temozolomide in Patientswith 1p and 19q
intact
Purpose of - Primary Objectives:
Study: 1) PHASE III for newly diagnosed 40 patients with tumor 1p and/or 19q dele-
tions: Determine whether patients treated with RT and concomitant/adju-
vant TMZ have superior survival compared to patients treated with RT
alone.
2) PHASE II for newly diagnosed AO patients with tumor 1p and 19q intact:
Determine whether RT and concomitant/adjuvant TMZ appears to be effica-
cious.
- Secondary Objectives:
1) Determine whether there is a difference in survival as a function of tumor 1p
and 19q status and MGMT promoter hypermethylation status in patients
treated with RT and concomitant/adjuvant TMZ.
2) Determine overall survival for the patients in the Phase II trial.
3) Determine time to progression, response rate, and proportions of patients
free of progression at 6, 12, and 24 months as a function of 1p and 19q gene
status and treatment arm.
4) Determine the toxicity/adverse event profile for all treatment arms.
5) Determine the quality of life and neurocognitive effects for all treatment
arms.
Schema: PHASE III: AO patients with 1p and/or 19q deleted tumors
Randomize:
Arm 1: RT + TMZ --> TMZ
Arm 2: RT
PHASE II: AO patients with 1p and 19q intact tumors
RT + TMZ --> TMZ
*****************************************************************************
N057K Phase I/II Evaluation of Everolimus (RAD001), Radiation andTemozolo-
mide (TMZ) Followed by Adjuvant Temozolomide and Everolimus
inNewly Diagnosed Glioblastoma
Purpose of 1) Identify a safe and tolerable dose of RAD001 when combined with temozo-
Study: lomide as adjuvant therapy following the completion of chemoradiotherapy.
CNS NCCTG CNS Committee Protocol Concepts - Page 1 of 2
Protocol Concepts for CNS - September 2007
2) Determine whether RAD001 combined with adjuvant temozolomide fol-
lowed by RAD001 alone improves survival in comparison to a historical
control in newly diagnosed GBM patients. Survival will be measured as the
proportion of patients alive at 12 months after study enrollment.
3) Determine whether FDG-response is associated with improved survival.
4) Validate potential molecular markers of RAD001 sensitivity identified in
ongoing laboratory studies using our panel of GBM xenografts.
Schema: Pre-Reg (Pathology Review)
Reg
RAD001 + RT + TMZ
*****************************************************************************
N057N Response to Pre-Radiation Chemotherapy as a Predictor of Survival inPa-
tients with Newly Diagnosed Malignant Astrocytoma
Purpose of 1) To correlate the response of newly diagnosed glioblastoma patients given
Study: pre-radiotherapy chemotherapy with survival outcome endpoints.
Schema: No Schema Defined
CNS NCCTG CNS Committee Protocol Concepts - Page 2 of 2
This page intentionally left blank.
Program Status Reports for MISCELLANUOUS - September 2007
Melanoma
N0275 Phase II Trial Evaluating Resection Followed by Adjuvant Radiation-
Therapy (RT) for Patients with Desmoplastic Melanoma
Other Closed Trials
947851 Phase II Trial of Fludarabine and Sandostatin LAR Depot for Relapsed-
Low-Grade Non-Hodgkins' Lymphoma
948151 Phase II Trial of Long-Term Tamoxifen in Patients with Asymptomat-
icB-Cell Chronic Lymphocytic Leukemia
958053 A Phase II Trial of 2-CDA in Previously Treated or Untreated
PatientsWith Mantle Cell Lymphoma
978151 A Phase II Study of Alternating Cycles of Fludarabine andCyclophos-
phamide in Previously Untreated Patients with B-Cell CLL
988151 Phase II Trial of Theophylline in Asymptomatic Patients With B-cell-
Chronic Lymphocytic Leukemia Previously Untreated with Chemother-
apy
988152 Phase II Study of Gemcitabine for Relapsed B-Cell Chronic Lymphocyt-
icLeukemia
N9981 A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexametha-
sone(DHAP) With Rituxan in Patients With Relapsed CD20+ B-
CellNon-Hodgkin's Lymphoma
N9982 A Pilot Study of Thalidomide as an Inhibitor of Angiogenesis in the-
Treatment of Myelofibrosis with Myeloid Metaplasia (MMM)
N9986 A Phase II Trial of Thalidomide in Patients with Relapsed ChronicLym-
phocytic Leukemia
N998B A Phase II Study of Thalidomide in the Treatment of Myelodysplastic-
Syndromes in Adults: A Clinical and Biologic Study
Protocol Concepts
MISC NCCTG MISC Committee Table of Contents - Page 1 of 2
Program Status Reports for MISCELLANUOUS - September 2007
E1F05 Phase II Study of Rituximab Given in Conjunction with Standard-
Chemotherapy in Primary Central Nervous System (CNS) Lymphoma
N0675 A Phase II Study of Temozolomide and Everolimus (RAD001) Therapy
forMetastatic Melanoma
N0775 A Phase II Trial of ABI-007 + Bevacizumab + Carboplatin (ABC) orTe-
mozolomide + Bevacizumab (TB) for the Treatment of Unresectable-
Stage IV Malignant Melanoma
N0782 Changes in BLyS and Other Cytokines After RItuximab Treatment
NLTEM Long Term Event Monitoring Protocol: An Administrative Tool
MISC NCCTG MISC Committee Table of Contents - Page 2 of 2
NCCTG Status Report for Study N0275 - September 2007
Phase II Trial Evaluating Resection Followed by Adjuvant Radiation Therapy
(RT) for Patients with Desmoplastic Melanoma
Purpose of - Primary Goals:
Study: 1) Assess the recurrence rates in patients with Desmoplastic Melanoma (DM)
greater than or equal to 1 mm deep treated with adjuvant radiotherapy after
surgical resection.
2) Assess recurrence rates in patients with locally recurrent DM treated with
adjuvant radiotherapy after surgical resection.
- Secondary Goals:
1) Evaluate the impact of adjuvant radiation therapy after surgical resection on
disease free and overall survival.
2) Evaluate the immediate and long-term morbidity of the addition of radio-
therapy surgery.
Study Chairs: Barbara Anamarie Pockaj M.D. QC Specialist: Butch K. Kvittem CCRP
Richard L. Deming M.D.
Statistician: Jake B. Allred M.S. Nurse Resource: Evie Brennan R.N.,
B.S.N., O.C.N.
Status: 07/11/2003 Activated Projected Number of Patients: 60
Excluded: None Final Accrual: NA
Stratification None
Schema: Registration
Radiation therapy
Treating Schedule:
Arm Dose Days FX/Day FX/Size # FX RT Length
30 Gy Twice a week 6 Gy 5 2.5 weeks
(Monday and
Thursday or Tues-
day and Friday)
Accrual: This study opened on July 11, 2003 and has accrued 14 eligible patients thus far.
Seven are white males and Seven are white females. All 14 patients have desmoplastic mela-
noma classified as >=1 mm deep.
MISC NCCTG MISC Committee N0275 - Page 1 of 2
NCCTG Status Report for Study N0275 - September 2007
Adverse Events: As of August 6, 2007, there was adverse event data available on all 14
patients. There was 1 grade 3 adverse event which was pruritis, which was deemed not related to
study treatment. Additionally the following grade 2 adverse events were reported: dermatitis-RT
(3 patients, 2 definitely related, 1 probably related), fatigue (1 patient, definitely related), pain-
RT (1 patient, definitely related), and alopecia (1 patient, not related).
Study Status: This trial was opened to NCCTG on July 11, 2003 with an expected accrual of 60
patients. Fourteen patients have been accrued thus far, two patients have accrued in the last 6
months.
MISC NCCTG MISC Committee N0275 - Page 2 of 2
NCCTG Status Report for Other Closed MISC Trials - September 2007
947851 * Phase II Trial of Fludarabine and Sandostatin LAR Depot for RelapsedLow-
Grade Non-HodgkinsLymphoma'
* Closed: 04/28/2000
* The manuscript for this trial is currently being written.
948151 * Phase II Trial of Long-Term Tamoxifen in Patients with AsymptomaticB-
Cell Chronic Lymphocytic Leukemia
* Closed: 07/31/1996
* A manuscript for this study is in preparation.
958053 * A Phase II Trial of 2-CDA in Previously Treated or Untreated PatientsWith
Mantle Cell Lymphoma
* Closed: 03/17/2000
* Study results on previously untreated patients were presented at the
1999 ASH meeting. An ASH abstract on previously treated patients
appeared in the 2001 NCCTG book.
* Manuscript status: Results have been submitted to JCO.
978151 * A Phase II Study of Alternating Cycles of Fludarabine andCyclophospha-
mide in Previously Untreated Patients with B-Cell CLL
* Closed: 10/09/2000
* Patients continue to be followed per protocol. The validity and
accuracy of the data items are being checked, and a manuscript is in
preparation.
988151 * Phase II Trial of Theophylline in Asymptomatic Patients With B-cell-
Chronic Lymphocytic Leukemia Previously Untreated with Chemotherapy
* Closed: 02/11/2000
* Data for this study are being analyzed and a manuscript is currently
being written.
988152 * Phase II Study of Gemcitabine for Relapsed B-Cell Chronic Lymphocyti-
cLeukemia
* Closed: 12/06/2002
* The manuscript for this trial is currently being finalized.
N9981 * A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexametha-
sone(DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-
HodgkinsLymphoma'
* Closed: 06/20/2003
* Study results were presented at the ASCO 2006 meetings.
* The manuscript for this trial is currently being finalized.
MISC NCCTG MISC Committee Other Closed Trials - Page 1 of 2
NCCTG Status Report for Other Closed MISC Trials - September 2007
N9982 * A Pilot Study of Thalidomide as an Inhibitor of Angiogenesis in theTreat-
ment of Myelofibrosis with Myeloid Metaplasia (MMM)
* Closed: 04/18/2003
* The quality and accuracy of the data are being validated and a
manuscript is in preparation.
N9986 * A Phase II Trial of Thalidomide in Patients with Relapsed ChronicLympho-
cytic Leukemia
* Closed: 08/15/2003
* Patients continue to be followed and a manuscript is in preparation.
N998B * A Phase II Study of Thalidomide in the Treatment of MyelodysplasticSyn-
dromes in Adults: A Clinical and Biologic Study
* Closed: 03/08/2002
* A manuscript on this trial has been published in Cancer:
Moreno-Aspitia A, Colon-Otero G, Hoering A, Tefferi A, Niedringhaus
RD, Vukov A, Li CY, Menke DM, Geyer SM, Alberts SR. Thalidomide
therapy in adult patients with myelodysplastic syndrome: a North
Central Cancer Treatment Group phase II trial. Cancer 2006;
107:767-72.
MISC NCCTG MISC Committee Other Closed Trials - Page 2 of 2
Protocol Concepts for MISC - September 2007
N0675 A Phase II Study of Temozolomide and Everolimus (RAD001) Therapy
forMetastatic Melanoma
Purpose of - Primary Goal
Study: 1) To estimate the median time to disease progression for patients diagnosed
with stage IV malignant melanoma treated with a regimen of RAD001 and
TMZ.
- Secondary Goals
1) Evaluate median overall survival (OS) time.
2) To assess the toxicity profile of the combination of RAD001 and TMZ when
used to treat patients with stage IV malignant melanoma.
3) To assess clinical benefit rates (i.e., stable disease, partial remission and
complete response rates).
4) To assess effects of therapy on tumor angiogenesis parameters.
5) Measure effect of therapy on the immune system.
Schema: Registation
RAD001 + TMZ
*****************************************************************************
NLTEM Long Term Event Monitoring Protocol: An Administrative Tool
Purpose of 1) To relieve the burden on IRBs and investigators at NCCTG institutions for
Study: continuing review of protocols that are closed to patient registration and on
which no patients are currently receiving protocol treatment or being
actively followed per the protocol specified test schedule.
2) To establish a mechanism for regular annual IRB approval to release study
update information to the NCCTG for these patients.
Schema: NCCTG determines protocol qualifies for NLTFU protocol.
Institution determines if protocol should be included.
Local IRB documents completion of final progress report and study
moved to NLTFU.
NLTFU report submitted for annual IRB review.
*****************************************************************************
N0782 Changes in BLyS and Other Cytokines After RItuximab Treatment
MISC NCCTG MISC Committee Protocol Concepts - Page 1 of 3
Protocol Concepts for MISC - September 2007
Purpose of 1) Determine the serum levels of BLyS and other cytokines in follicular lym-
Study: phoma patients treated with 4 doses of Rituximab both at baseline and after
4 months.
2) Correlate the cytokine changes with clinical endpoints such as reponse to
treatment and time to progression.
Schema: No Schema Defined
*****************************************************************************
N0775 A Phase II Trial of ABI-007 + Bevacizumab + Carboplatin (ABC) orTemo-
zolomide + Bevacizumab (TB) for the Treatment of UnresectableStage IV
Malignant Melanoma
Purpose of - Primary Goal
Study: 1) To assess the anti-tumor activity in terms of the percentage of patients who
are progression-free at 6 months and safety profile of each of the treatment
regimens.
- Secondary Goals
1) To estimate the response rate in each of the treatment regimens.
2) To estimate the distribution of PFS times and OS time of each treatment reg-
imen.
Schema: Randomize
Arm A (Temozolomide + Bevacizumab)
Arm B (Bevacizumab + ABI-007 + CBDCA)
*****************************************************************************
E1F05 Phase II Study of Rituximab Given in Conjunction with StandardChemo-
therapy in Primary Central Nervous System (CNS) Lymphoma
Purpose of
Study:
MISC NCCTG MISC Committee Protocol Concepts - Page 2 of 3
Protocol Concepts for MISC - September 2007
Schema: Randomize
Arm A (Temozolomide + Bevacizumab)
Arm B (Bevacizumab + ABI-007 + CBDCA)
MISC NCCTG MISC Committee Protocol Concepts - Page 3 of 3
This page intentionally left blank.
Fall 2007
Cancer Control Program
Please note that this report combines historical data regarding the NCCTG Cancer Control
Program since its initiation and newer developments in the program. The most current
information, about active studies and studies in development, is provided in bold italics.
The NCCTG’s Cancer Control Program can be subdivided into four major areas: 1) studies
aimed at the prevention and/or amelioration of symptoms related to cancer and/or cancer
therapy; (2) screening studies aimed at the detection of early, more treatable cancer; (3) cancer
prevention studies and (4) studies designed to test complementary and alternative (CAM)
therapies.
I. Symptom Control Studies
A prominent component of the NCCTG Cancer Control Program to date focuses on trials aimed
at the prevention and/or alleviation of symptoms resulting from cancer and/or cancer therapy.
Major areas of research in this arena have included studies designed to evaluate (1) methods of
preventing or alleviating mucositis, (2) treatment of cancer anorexia/cachexia, (3) therapy of
hormone deprivation symptoms/problems in patients where hormonal treatment is
contraindicated, (4) methods of improving our ability to care for patients suffering from pain,
and (5) studies aimed at finding ideal therapy with erythropoietic agents for patients with
anemia.
Mucositis: In 1986, our first mucositis protocol was developed to study whether an
allopurinol mouthwash could prevent 5FU-induced stomatitis (NCCTG 86-46-51) based
on promising pilot information obtained elsewhere. This study clearly demonstrated that
the purported allopurinol mouthwash was not useful in this situation (published in
Cancer). Subsequently, another trial (NCCTG 88-92-53) clearly demonstrated that oral
cryotherapy could markedly reduce 5FU-induced mucositis (published in the Journal of
Clinical Oncology). The positive results from this study (which were subsequently
confirmed in a confirmatory trial performed elsewhere) changed practice at many
institutions, and have been incorporated into many large cancer treatment trials
that utilize 5FU, thus benefiting thousands of cancer patients. A follow-up trial
(NCCTG 89-92-58) evaluated different durations of oral cryotherapy in patients receiving
bolus 5FU-based chemotherapy. The results from this protocol did not suggest any
advantage for continuing oral cryotherapy longer than 30 minutes (published in Cancer).
Three subsequent trials, all following promising leads from pilot studies, were completed.
All three failed to suggest any benefit for the studied agent. These trials evaluated (1) a
chamomile mouthwash preparation (NCCTG 90-92-56 published in Cancer); (2)
sucralfate (NCCTG 92-92-51 published in the Journal of Clinical Oncology); and (3)
glutamine (NCCTG 95-92-51; published, American Journal of Clinical Oncology).
Having developed considerable experience studying chemotherapy-induced mucositis,
we then began to study radiation therapy-induced mucositis. Our first placebo-controlled
study in this area was developed to evaluate chlorhexidine and an oral nonabsorbable
antibiotic lozenge to determine whether either would be helpful in alleviating stomatitis
resulting from irradiation of the oral mucosa (NCCTG 92-49-51). Based on an interim
analysis, the chlorhexidine arm was closed due to a lack of benefit (manuscript published
in the Journal of Clinical Oncology) while the antibiotic lozenge (versus a placebo)
investigation was continued; results from this study (where there was no physician-
judged benefit but a suggestion of mild patient-judged benefit) have been published in
Cancer. A protocol to study capsaicin lozenges in this situation (NCCTG 96-92-57)
accrued a smaller than expected number of patients but came to a conclusion that there
was not any suggestion that this therapy was beneficial for this patient group. With
regard to radiation-induced esophagitis, an NCCTG study (NCCTG 92-49-51)
demonstrated no benefit for a sucralfate liquid (published in the Journal of Clinical
Oncology). Also related to the treatment of therapy-related GI mucosal injury, a protocol
was opened to study whether osalazine could inhibit radiation-induced diarrhea (NCCTG
91-92-53). This trial was closed early because of excessive drug toxicity (published in
the International Journal of Radiation Oncology Biology Physics). Sucralfate was also
studied for this situation with negative results (NCCTG 94-92-52, published in the
Journal of Clinical Oncology). We subsequently completed accrual on a trial to study
glutamine for preventing radiation proctitis (NCCTG 96-92-56). Results from this study
did not reveal any benefit for glutamine. A manuscript from this project was published in
the Journal of Clinical Oncology. A protocol designed to study a somatostatin analog
as an agent to prevent diarrhea in patients receiving pelvic irradiation (N00CA)
completed accrual in 2005. Unfortunately, it did not demonstrate any benefit for the
somatostatin analog. It was presented as an oral presentation at the 2006 ASCO
meeting and a manuscript is in development.
Anorexia/Cachexia: Another active area for the NCCTG Cancer Control program has
involved studies aimed at the treatment of cancer anorexia/cachexia. After an initial trial
(NCCTG 87-92-51) suggested that cyproheptadine was not very useful in this situation
(published in Cancer), a follow-up protocol clearly demonstrated that megestrol acetate
could stimulate the appetite of, and cause weight gain in, patients suffering from severe
cancer anorexia/cachexia (NCCTG 88-92-51). This was the first published,
randomized, placebo-controlled clinical trial to demonstrate that any medication
could increase appetite and cause non-fluid weight gain in patients suffering from
cancer anorexia/cachexia. The results of this trial attracted substantial national interest
(presented at ASCO in 1990 where it was chosen by ASCO for a press release, published
in the Journal of the National Cancer Institute). Subsequently, 343 eligible patients were
entered on another protocol evaluating various doses of megestrol acetate. It was
determined that there was a positive dose-response relationship for this drug in patients
with cancer anorexia/cachexia (NCCTG 89-92-55). This manuscript was published in the
Journal of Clinical Oncology. Another randomized, double-blind, placebo-controlled
trial (NCCTG 91-92-54) determined that the drug, pentoxifylline, was not helpful for
alleviating cancer anorexia/cachexia (published in the Journal of Clinical Oncology). We
next completed a protocol comparing megestrol acetate to dexamethasone and to
fluoxymesterone (NCCTG 91-92-52) in patients with cancer anorexia/cachexia, revealing
relatively equivalent efficacy between megestrol acetate dexamethasone with inferior
efficacy from fluoxymesterone; and that megestrol acetate was better tolerated than
dexamethasone. (published in the Journal of Clinical Oncology). A protocol (NCCTG
95-92-55) comparing megestrol acetate to dronabinol to both drugs in patients with
cancer anorexia/ cachexia completed accrual in December 1999 and a manuscript,
indicating no suggestion of benefit of dronabinol over megestrol acetate was published in
the Journal of Clinical Oncology. This latter trial had a translational laboratory
component in it whereby IL-6 levels were measured at baseline and one month later
(published in the Journal of Supportive Care in Cancer). A protocol to compare an
eicosopentenoic acid enriched nutritional supplement to megestrol acetate to both, as
therapies for cancer anorexia/cachexia, opened in February 2000 and closed for patient
accrual in the summer of 2002 (presented at the 2003 ASCO meeting and subsequently
published in the Journal of Clinical Oncology). Next, a study of the tumor necrosis
factor (TNF)-inhibitor, etanercept (N00C1), opened for patient accrual in early 2003.
This study closed early due to slow accrual, on March 1, 2005, after about 70 patients
were enrolled. In February 2005, a placebo-controlled trial of creatine (N02C4) was
opened for accrual. It is accruing patients at a current rate of about 10 patients per
month and its accrual goal is expected to be reached by the fall of 2007. A study of
zinc replacement, in patients receiving radiation to the head and neck to try to prevent
troubles with taste alterations (N01C4) completed accrual in the fall of 2005.
Unfortunately, zinc did not appear to be helpful in this situation. Data from this project
were accepted for a presentation at ASTRO, 2007 and a manuscript is in press at the
International Journal of Radiation Oncology, Biology, Physics.
We have completed three related trials in specific disease populations. NCCTG 89-20-51
was designed to determine whether megestrol acetate could improve the survival and/or
quality of life for previously untreated small cell lung cancer patients; 243 patients were
accrued (manuscript published in the Journal of Clinical Oncology). Two other trials
evaluated hydrazine sulfate, a drug that had been reported to have nutritional-enhancing
properties, in patients with lung cancer receiving concomitant chemotherapy (NCCTG
89-24-51) and in patients with 5FU-resistant advanced colorectal cancer (NCCTG 89-49-
51). Both of these trials failed to show any benefit for hydrazine sulfate, and manuscripts
were published for each of them in the Journal of Clinical Oncology during 1994. These
two manuscripts were chosen, on several occasions (a total of 4 separate and independent
times) as one of the best in their disease sites (GI, lung, supportive care, and lung again),
to be republished in separate issues of Classic Papers and Current Comments. In
October 2002, we initiated a protocol (N01C9) to study the TNF inhibitor, influximab, in
patients with non-small cell lung cancer. This trial has been closed to accrual and a
manuscript is being developed.
Hormone Deprivation Symptoms: Hot flashes can be a major problem in
postmenopausal women and in male patients who have had androgen ablation therapy,
especially since estrogen therapy classically been considered to be relatively
contraindicated in both situations. We completed accrual on a protocol (NCCTG 89-92-
54) designed to evaluate the use of the antihypertensive medication, clonidine, in this
disorder. Manuscripts from this trial were published in the Journal of Clinical Oncology
(females) and the Journal of Urology (males). The results of this study revealed that
clonidine did decrease hot flashes but also caused toxicity that counterbalanced this
benefit. Subsequently, another protocol was opened to evaluate low doses of megestrol
acetate for the therapy of this problematic symptom in these patient populations (NCCTG
90-92-55). This positive study made national news, was presented at the 1994 ASCO
meeting, and was published in the New England Journal of Medicine. A follow-up
trial (NCCTG 95-92-54) looked at whether patients who entered the megestrol acetate
trial were continuing megestrol acetate 2-3 years later and queried them regarding their
satisfaction and perceived toxicities; results suggested continued benefits in patients for
long terms. A manuscript from this trial was published in Cancer. A trial to study
vitamin E in breast cancer patients with hot flashes (NCCTG 95-92-53) was completed
and published in the Journal of Clinical Oncology. This trial showed that vitamin E
decreased hot flashes a little bit more than did a placebo and that it did not cause any
evident toxicity. A protocol to study a soy phytoestrogen for symptomatic hot flashes
(NCCTG 96-92-58) in breast cancer survivors reached its accrual goal in 2 months, was
presented at the 1998 ASCO meeting and was published in the Journal of Clinical
Oncology. This study was convincingly negative. A subsequent study of the
antidepressant, venlafaxine, (NCCTG 97-92-54) rapidly accrued 229 patients. This
trial demonstrated that venlafaxine did substantially diminish hot flashes. It was
submitted as an abstract to the May 2000 ASCO meeting and was chosen as one of
five abstracts (out of more than 2000 submitted) to be presented at the meeting’s
plenary session; it was published in The Lancet in December 2000. As a result of the
above-completed protocols, two other manuscripts have been published. They deal with
definitions of hot flash severities in men (Urologic Nursing) and in breast cancer
survivors (Journal Pain and Symptom Management). A protocol (N99C7) to compare
venlafaxine to MPA for hot flashes in women completed accrual in 2004 and was
presented at the 2005 ASCO meeting. A manuscript from this trial was published in
JCO.A placebo-controlled study of black cohosh (N01CC) opened in the Fall of 2003 and
completed its planned accrual by March 2004. It was presented at the 2005 ASCO
meeting and was published in the JCO. Lastly, a protocol to study patients with hot
flashes that are inadequately relieved by an antidepressant (N03C5) was opened in
November 2004. Eligible patients were randomized to add gabapentin to their
antidepressant versus to substitute gabapentin for their antidepressant. Results from this
trial, which did not show any additional benefit for continuing both medications, were
orally presented at the 2006 ASCO meeting; a manuscript has been submitted for
publication. Recently, a protocol to study gabapentin in men with prostate cancer with
hot flashes (N00CB) completed accrual. An abstract regarding it was orally presented
at the 2007 ASCO meeting and a manuscript has been circulated to NCCTG co-
authors for review. A phase III trial of citalopram for the treatment of hot flashes in
women (N05C9) opened for accrual in late 2006, and completed its accrual goal of
over 200 patients by early 2007. It is currently maturing so that an analysis can be
performed. The NCI approved a new concept in 2007 to conduct a placebo-controlled
trial of pregabalin (N07C1). A protocol was submitted to the NCI in July 2007.
Another quite bothersome clinical problem for some estrogen-deprived women is vaginal
dryness and/ or pruritus. Although local estrogen preparations usually will relieve these
symptoms, in the past they generally had been considered to be relatively contraindicated
in patients with breast cancer. A protocol (NCCTG 91-39-51) was developed to evaluate
a new nonhormonal agent (Replens), which appeared to be beneficial in some women
with this problem. This project was presented at the 1996 ASCO meeting and a
manuscript was published in the Journal of Clinical Oncology. A concept was approved
by the NCI to perform a placebo-controlled trial of pilocarpine for alleviating vaginal
dryness (N04CA). This protocol opened for accrual in early 2007, and, as of 3/10/07,
had accrued 40 patients, at about the predicted accrual rate.
In the recent past, the NCCTG cancer control program has embarked on a new area of
investigation, related to a hormone deprivation problem, that being the study of
osteoporosis-related problems in patients with cancer. First, a 4 arm study was
developed to evaluate the utility of low dose estrogen or a bisphosphonate (risedronate)
or both, compared to a calcium/vitamin D alone in men receiving androgen ablation
for prostate cancer, to see if this treatment can help prevent osteoporosis (N01C8).
This study was closed in July 2005 and data from it are maturing. Secondly, another
protocol has been developed to study the use of a bisphosphonate (risedronate) to try to
prevent osteoporosis from developing in premenopausal women receiving adjuvant
chemotherapy for breast cancer (N02C1). Its accrual goal was reached in the spring
of 2006; data are maturing. In addition, another trial was opened in early 2005 to
study immediate versus delayed use of zolendronic acid for women starting letrozole
therapy after tamoxifen (N03CC). It accrued patients at a rate of about 50 per month
with its accrual goal being reached in the spring of 2006. Data from this trial are
maturing. The NCI has approved a concept to study a new RANKL antibody,
denosumab, for premenopausal women receiving adjuvant chemotherapy for breast
cancer, to see if it will attenuate bone loss (N06C9). A protocol is currently at the NCI,
being reviewed.
Lastly, another potential hormonal deprivation problem relates to libido in female cancer
survivors. Based on tantalizing background information, a placebo-controlled trial
(N03CB) was developed to evaluate the efficacy and safety of transdermal testosterone in
women who perceive that their libido is less than ideal. This protocol, which opened in
2004, had brisk accrual and was closed in January 2005. It was presented at an oral
session at the 2006 ASCO meeting and a manuscript was published in JNCI, in the
spring of 2007. Work is ongoing to develop another study in this area.
Anemia studies: The NCCTG Cancer Control program completed a placebo-controlled,
randomized clinical trial of erythropoietin in patients with anemia associated with
chemotherapy (NCCTG 97 92 53). This positive study was presented in an oral session
at the 2002 ASCO meeting. A manuscript is in press at JCO. A subsequent protocol was
developed to randomly compare, after a three week run-in period, weekly treatment
versus treatment every 3 weeks at triple the individual doses. This study opened in the
first half of 2003, and reached its accrual goal of 330 patients by March 2004. An
abstract from this trial was submitted to the 2005 ASCO meeting and a manuscript was
published in JCO.
Analgesic Studies: Analgesic studies completed and published include: (1) a placebo-
controlled trial assessing the role of the psychostimulant drug, methylphenidate, in
improving pain relief and general alertness in patients requiring a strong opioid drug
(NCCTG 89-92-51 published in Supportive Care in Cancer); (2) a placebo-controlled
trial of a topical local anesthetic cream (EMLA Cream) in the management of painful
percutaneous access procedures in children (NCCTG 89-92-52 published in the Journal
of Pain and Symptom Management); (3) a protocol designed to study the efficacy of
transdermal fentanyl for the management of cancer pain (NCCTG 88-92-52 published in
the Journal of Pain and Symptom Management); (4) a pilot study of the utility of orally
administered local anesthetics (mexiletine and flecainide) for cancer pain (NCCTG 91-
92-51); published in the Journal of Pain and Symptom Control); and (5) a study of
capsaicin cream in the management of long-term surgical neuropathic pain (NCCTG 90-
92-54; presented at the 1996 ASCO meeting). This latter positive study was selected
as one of less than 2% of submitted abstracts for an ASCO press release and it
received substantial national and international press coverage. It was published in
the Journal of Clinical Oncology. Another analgesic protocol was opened in 2004 to
study a lidocaine patch for alleviating post-surgical neuropathic pain (N01CB). A
manuscript regarding this project was circulated for NCCTG review in July 2007. .
Lastly, the NCI has approved a protocol for a randomized trial of radiation therapy
versus percutaneous cryoablation of painful bony metastases (N06C6). Efforts are
ongoing to get this opened through the CTSU, which should be the first cancer control
study ever opened using this mechanism.
Chemotherapy induced neuropathy: The NCCTG cancer control program has
developed a program designed to alleviate chemotherapy-induced neuropathy. The first
such study evaluated nortriptyline as a means of alleviating chemotherapy-induced
neuropathy (93-92-52). Negative results were published in the journal Pain. Another
protocol, which opened for accrual in the spring of 2002 and reached its accrual goal in
2003, was designed to evaluate gabapentin for chemotherapy related peripheral
neuropathy (N00C3). It was selected for an oral presentation at the 2005 ASCO meeting.
A subsequent protocol, designed to study lamotrigine for the same problem (N01C3),
opened for accrual in 2004 an rapidly completed planned accrual by April 2005. Results
from it were presented at the 2006 ASCO meeting. A placebo-controlled phase III study
of intravenous calcium/magnesium as prophylaxis of oxaliplatin-induced sensory
neurotoxicity (N04C7) was opened in January 2006 and accrued just over 100 patients.
This study was abruptly closed in the summer of 2007 upon hearing information that a
data monitoring committee closed another study of Ca/Mg in patients receiving
oxaliplatin for metastatic colorectal cancer, based on a substantially lower cancer
response rate in patients on the active arm, versus a placebo arm. Another protocol
has been opened to study vitamin E as a means of preventing of chemotherapy-induced
neuropathy (N05C3) , having accrued 108 patients by 8/10/07 at a faster than predicted
accrual rate. In 2007, the NCI approved a placebo-controlled protocol to look at a
topical preparation of amitryptyline, ketamine and baclofen as a treatment for patients
with chemotherapy-induced painful neuropathy. This study should open for accrual in
the fall of 2007.
Treatment-induced skin toxicity: The NCCTG cancer control program has evaluated
agents to try to alleviate treatment induced skin toxicity. The first of these was a double-
blind, placebo-controlled trial designed to determine whether an aloe vera gel could
inhibit radiation therapy-induced dermatitis (NCCTG 90-92-52). This study failed to
demonstrate any benefit for the aloe vera (manuscript was published in the International
Journal of Radiation Oncology Biology Physics). The second trial was a placebo-
controlled, double-blinded study, that opened in December 2004, to study tetracycline
as an agent to try to prevent EGFR inhibitor-induced skin rashes (N03CB).
This trial completed accrual in 2005 and was orally presented at the 2007 ASCO
annual meeting. The results of it demonstrated that the tetracycline did not appear to
decrease the incidence of rash, but did appear to decrease the rash severity. As the
rash severity was a secondary study endpoint, it was decided to re-open the study for an
additional 60 patients, with rash severity being the new primary endpoint. Another
protocol (N05C4) opened in late 2006 to study whether a sunscreen preparation can
prevent EGFR inhibitor-induced dermatitis. This study closed in early 2007, after it
rapidly met its accrual goal, and is maturing so that it can be analyzed. Another trial
(N05C5) opened in the summer of 2006 to evaluate vitamin B6 and/or a urea based
cream to see if either or both will help to alleviate capecitabine-induced hand/foot
syndrome toxicity. Based on a 2007 ASCO presentation that concluded that vitamin B6
did not decrease the capecitabine-induced hand/foot syndrome, a protocol modification
is being submitted to the NCI to request that this trial be reduced to only asking the
question regarding the urea-based cream. Lastly, the NCI approved another trial to
evaluate a steroidal cream, mometasone furoate, as a means of alleviating radiation
therapy-induced skin dermatitis (N06C4). This should open for accrual in the fall of
2007.
Cancer Fatigue: Fatigue is a common problem in patients with cancer. Treatment
options for it are limited. In response, a protocol (N03CA) was developed to look at
ginseng as an agent to try to alleviate cancer-related fatigue. This trial rapidly accrued
patients and completed its planned accrual in 2006. An abstract regarding it was orally
presented at the 2007 ASCO annual meeting. This abstract, which revealed positive
pilot information to suggest that the ginseng was helpful and that it thus needed to be
studied in a more definitive phase III study manner, was chosen by ASCO as a press
release; it received considerable national press attention. In follow-up to the results of
this protocol, a concept (N07C2) for such a placebo-controlled, phase III trial was
submitted to the NCI in July 2007. A subsequent protocol, evaluating Concerta (a long
acting methylphenidate preparation) for cancer fatigue (N05C7), has been approved by
the NCI. It should, hopefully, open in 2007.
Anti-emetic studies: In 2006, the NCCTG Cancer Control Program initiated work on
studies dealing with cancer treatment related nausea and vomiting. A pilot, phase II,
randomized, dose-finding concept of oral palonosetron is being developed for
prevention of radiation therapy induced nausea and vomiting. This may be the first
trial of oral palonosetron in this country. In addition, a randomized double-blind,
placebo-controlled concept of haloperidol, diphenhydramine, and lorazepam (HDL) is
being developed for the treatment of (as opposed to prevention of) chemotherapy
induced nausea and vomiting (CINV) occurring despite prophylactic antiemetic
therapy, among patients receiving highly or moderately emetogenic chemotherapy.
This is initially proposed as a 5 arm study to look at each of the individual drugs versus
the combination versus a placebo. If one of the active study arms looks better than a
placebo, it is proposed to convert this to a more definitive phase III trial.
Miscellaneous: Other DCP-approved miscellaneous symptom control studies include
several completed projects: (1) A trial designed to evaluate ocular ice packs for
preventing 5FU-induced ocular toxicity (NCCTG 89-92-51) was published in Cancer in
1994. (2) A trial of coumarin in breast cancer survivors with troublesome lymphedema
(NCCTG 94-92-55) was published in the New England Journal of Medicine and, (3) A
study of low molecular weight heparin in patients without thrombosis (NCCTG 979251),
which failed to show any survival benefit (versus a control arm) and Is in press in the
Mayo Clinic Proceedings.
Another protocol (N04C2) has opened to study a somatostatin analog in patients with
ascites, in a double-blinded, placebo-controlled fashion.
A concept to study a chocolate product for cancer-related cough (N06C5) was approved
by the NCI and we are attempting to get the protocol from this project approved.
II. Screening Studies
With regard to screening studies, over 22,000 subjects were contacted and over 12,000
were accrued to a large HemoQuant screening trial (NCCTG 84-46-51). A manuscript
reporting the results of this project was published in JAMA. This paper caused
substantial scientific and lay press discussion, highlighted the limitations of this test, and
focused attention on the need to develop more sensitive and specific stool markers.
Currently, the NCCTG is participating in another screening trial, which evaluates DNA in
stool (MC9944).
Another screening trial (NCCTG 96-92-52) was designed to evaluate mammographic
patterns in Native American Women. Results from this trial were presented at the 1997
ASCO meeting.
III. Cancer Prevention Studies
Our Group has recognized the importance of cancer prevention research, has not been
bashful in this regard, and has enthusiastically developed and/or participated in a number
of cancer prevention trials.
The NCCTG developed an intergroup trial (NCCTG 89-51-51) to evaluate relatively low
doses of difluoromethylornithine (DFMO), one of the most promising cancer
chemoprevention agents in experimental models. This trial accrued 76 patients with a
history of superficial bladder cancer. A manuscript was published in Cancer
Epidemiology Biomarkers and Prevention. In addition, the NCCTG completed
participation in intergroup protocols designed to evaluate: (1) 13 cis-retinoic acid as an
agent that might be able to prevent new lung cancers in patients with a history of resected
stage I non-small cell lung cancer (NCCTG 91-24-52) (2) 13 cis-retinoic acid as a
chemoprevention agent in patients with resected head and neck cancers (NCCTG 88-74-
51); and (3) aspirin as an agent to prevent colon polyps (NCCTG 94-92-51). The latter
trial was published in the New England Journal of Medicine in March 2003.
The NCCTG has completed accrual on three studies looking at the means of helping
patients with nicotine dependence. The first of these trials (NCCTG 96-92-55) is a trial
that compared a nicotine spray to nicotine patches to both as means of helping patients
stop smoking. This trial opened in the summer of 1997 and rapidly met its original
accrual goal of 1200 patients. The manuscript from this study was published in the
Journal of Clinical Oncology in 2003. The second nicotine dependence study (NCCTG
96-92-54) was designed to evaluate the efficacy of the antidepressant, buproprion, as a
means for facilitating smoking cessation. This trial, designed to accrue 600 subjects,
opened in early 1998. This study was published in The Journal of Tobacco and Nicotine
Research. A third smoking cessation trial was opened in the summer, 2001, compared
nicotine inhalers to bupropion to nicotine inhalers plus bupropion for smoking cessation
efficacy and relapse prevention, and is currently undergoing analysis.
A chemoprevention trial for patients with prostatic intraepithelial neoplasia (PIN) accrued
patients between 9/1997 - 9/2000 (NCCTG 95-92-57). In this study, 63 patients with PIN
were randomized to receive flutamide versus placebo. A manuscript regarding the results
of this study, suggesting no benefit from flutamide in this clinical situation, is in press in
the American Journal of Therapeutics.
Two further chemoprevention trials conducted in the NCCTG include (1) a skin cancer
chemoprevention trial with the retinoid, Acitretin versus placebo (NCCTG 96-92-51),
and (2) a trial designed to evaluate the immunostimulatory agent, imiquimod, in patients
with cervical dysplasia (NCCTG 98-92-51). Results from these trials are pending.
Lastly, a chemoprevention trial is being developed by the SWOG, regarding the study
of calcium and selenium for the prevention of colon polyps. The NCCTG has agreed to
participate, in an intergroup manner, in this study.
IV. Complementary and Alternative Medicine (CAM) Studies
The NCCTG has had considerable expertise in conducting CAM studies in the past, has a
number of active CAM studies presently ongoing, and has plans for future CAM studies.
Many of these have been discussed in the sections above, but will be briefly highlighted
again in this section.
The NCCTG Cancer Control Program conducted two studies looking at hydrazine
sulfate, an unorthodox compound that was relatively popular in the 1980s and early
1990s, in patients with advanced cancer (NCCTG 892451 and NCCTG 894951). The
negative results of both of these trials were published in the Journal of Clinical
Oncology. On four separate occasions, one or the other of these articles was chosen by
ASCO to be republished in subsequent “best of the best” publications.
Three NCCTG CAM studies involved means of trying to alleviate chemotherapy-induced
mucositis. Two of these trials regarded the use of oral cryotherapy (ice chips) for
prevention of 5-FU induced mucositis (NCCTG 88 92 53 and NCCTG 89 92 58),
published in the Journal of Clinical Oncology and Cancer. Another such CAM trial
evaluated chamomile tea for prevention of mucositis (NCCTG 909256). The negative
results of this study were published in Cancer.
Another CAM protocol dealt with capsaicin (the active substance of chili peppers) cream
for study of neuropathic pain (NCCTG 909254). This study’s report, which clearly
demonstrated that it alleviated post-surgical neuropathic pain, was selected for a press
release at ASCO, the year that it was presented. It also was published in the Journal of
Clinical Oncology. The positive results from this study and a positive pilot report from
another study evaluating a capsaicin lozenge, led us to develop a placebo-controlled trial
of a capsaicin lozenge to try to alleviate radiation induced oral mucositis. The study
results, which were convincingly negative, were reported in the Journal of Integrative
Oncology.
Three NCCTG hot flash studies have involved CAM agents. The first of these evaluated
vitamin E (NCCTG 959253), reporting that this vitamin did slightly decrease hot flashes
in women suffering from such. Another such protocol (NCCTG 969258) evaluated a soy
phytoestrogen product. The results of this trial were convincingly negative. A protocol
to evaluate black cohosh in a placebo-controlled manner, as a therapy for hot flashes
(N01CC), was presented at the 2005 ASCO meeting. It did not relieve hot flashes.
Another CAM substance, that being coumarin (not to be confused with the anti-
coagulant, coumadin) was carried out in patients with post-mastectomy lymphedema
(NCCTG 949255). This trial was published in the New England Journal of Medicine
demonstrating that this unorthodox compound did not help lymphedema, contrary to a
prior report in the New England Journal of Medicine. This report also demonstrated that
coumarin had substantial hepatotoxicity in a minority of patients.
An aloe vera gel preparation was studied as a potential means of trying to prevent
radiation-induced dermatitis (NCCTG 909255). This trial was a negative study.
The NCCTG was awarded special funds to complete a trial to evaluate shark cartilage in
patients with advanced cancer (NCCTG 971151). A manuscript from this trial was
published in Cancer in 2005.
There are currently a number of active NCI-approved CAM Protocols. A protocol to
evaluate zinc sulfate as an agent to prevent radiation therapy induced dysgeusia
(N01C4) completed accrual in the fall of 2005. A study evaluating gingko biloba as an
agent to try to prevent cognitive dysfunction in patients receiving adjuvant
chemotherapy for breast cancer (N00C9) completed accrual in 2006; data from it are
maturing. Another open study, designed to evaluate valerian as an agent to help
alleviate insomnia (N01C5), opened in March 2004 and has completed accrual; it is
maturing for analysis. A CAM study (N02C4) is designed to look at creatine, an agent,
which has been favored by muscle builders, to alleviate cancer anorexia/cachexia. It
has accrued over 275 patients, and should close by the fall of 2007. A randomized
placebo-controlled pilot protocol (N03CA) completed enrolling patients to look at
ginseng as an agent to try to alleviate cancer-related fatigue, was presented at the 2007
ASCO meeting, and led to the development of a definitive phase III concept. A concept
to study a chocolate product for cancer-related cough (N06C5) was approved by the
NCI and we are attempting to get the protocol from this project approved.
Program Status Reports for CANCER CONTROL - September 2007
Cancer Control
N00CB A Phase III Randomized, Double-Blind, Placebo-Controlled Trial
ofGabapentin in the Management of Hot Flashes in Men
N02C4 Phase III Double-Blind, Placebo-Controlled Randomized Comparison
ofCreatine for Cancer-Associated Weight Loss
N03CB An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline-
for Gefitinab- or Cetuximab- Induced Skin Rash (or Other Epidermal-
Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)
N04C2 An Exploratory, Randomized, Placebo-Controlled Trial of DepotOct-
reotide (Sandostatin LAR Depot ) for Symptomatic Ascites in Cancer-
Patients
N04C7 A Phase III Randomized, Placebo-Controlled, Double Blind Study ofIn-
travenous Calcium/Magnesium to Prevent Oxaliplatin-Induced Sensory-
Neurotoxicity
N04CA Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double
Blind,Placebo-Controlled Study
N05C3 The Use of Vitamin E for Prevention of Chemotherapy Induced Periph-
eralNeuropathy: A Phase III Double-Blind Placebo Controlled Study
N05C4 A Phase III, Randomized, Double-blind, Placebo-Controlled Trial
ofProphylactic Topical Sunscreen to Prevent Erlotinib- orCetuximab-
Induced Skin Rash [or Other Epidermal Growth Factor Receptor(EGFR)
Inhibitor-Induced Skin Rash]
N05C5 A Phase III Randomized , Placebo-controlled, Double-blind Trial toDe-
termine the Effectiveness of a Urea/Lactic Acid-Based TopicalKera-
tolytic Agent and Vitamin B-6 for Prevention ofCapecitabine-Induced
Hand and Foot Syndrome
N05C9 Phase III Randomized, Double-blind, Placebo-controlled Evaluation
ofCitalopram for the Treatment of Hot Flashes
Protocol Concepts
N03C9 Phase III Trial of Honey for the Treatment of Radiation- orCombination
Therapy-Induced Stomatitis
CONTROL NCCTG CONTROL Committee Table of Contents - Page 1 of 4
Program Status Reports for CANCER CONTROL - September 2007
N05C7 Long Acting Methylphenidate (Concerta) for Cancer-Related Fatigue:
APhase III, Randomized Double-Blind Placebo Controlled Study
N06C4 Phase III Randomized Double-Blind Study of Mometasone Furoate ver-
susPlacebo in the Prevention of Radiation Dermatitis in Breast Cancer-
Patients Receiving Radiation Therapy
N06C5 Chocolate as a Cough Suppressant: A Phase III, Double-Blinded,Ran-
domized Trial
N06C6 A Phase III Randomized Trial of Cryoablation vs. Radiation for thePalli-
ation of Painful Bone Metastases
N06C9 A Phase III Randomized, Placebo-Controlled, Double-Blind Trial ofDe-
nosumab for Prevention of Bone Loss in Premenopausal WomenUnder-
going Chemotherapy for Primary Breast Carcinoma
N06CA The Use of Topical Baclofen, Amitriptyline HCl, and Ketamine (BAK)
ina PLO Gel vs. Placebo for the Treatment of Chemotherapy InducedPe-
ripheral Neuropathy: A Phase III Randomized Double-Blind Placebo-
Controlled Study
N06CB Phase III Double-Blind, Placebo Controlled Study of Haloperi-
dol,Diphenylhydramine, & Lorazepam (HDL) for the Treatment of Che-
motherapyInduced Nausea and Vomiting (CINV) Occurring Despite
ProphylacticAntiemetic Therapy Among Patients Receiving Highly or
ModeratelyEmetogenic Chemotherapy
N07C1 A Phase III, Randomized, Double-Blind, Placebo-controlled Evalua-
tionof Pregabalin for Alleviating Hot Flashes
N07C2 The Use of Wisconsin Ginseng (panax quinquefolius) to ImproveCan-
cer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled-
Phase III Study
Other Closed Trials
969251 Chemoprevention Trial of Acitretin Versus Placebo in Patients at High-
Risk for Basal Cell Carcinoma or Squamous Cell Carcinoma
989251 Phase II Topical Immunomodulatory Therapy With Imiquimod for
theChemoprevention of Recurrent and High-Grade Cervical Intraepithe-
lialNeoplasia (CIN)
CONTROL NCCTG CONTROL Committee Table of Contents - Page 2 of 4
Program Status Reports for CANCER CONTROL - September 2007
N00C1 Phase III Placebo-Controlled, Randomized, Double-Blind Comparison
ofEtanercept(Enbrel) Versus Placebo for the Treatment ofCancer-Asso-
ciated Weight Loss and Anorexia
N00C3 The Efficacy of Gabapentin in the Management of Chemotherapy-
InducedPeripheral Neuropathy: A Phase III Randomized, Double-
Blind,Placebo-Controlled, Crossover Trial
N00C9 The Use of Ginkgo Biloba for the Prevention of Chemotherapy- Relat-
edCognitive Dysfunction
N00CA Phase III Double-Blind Study of Depot Octreotide Versus Placebo in
thePrevention of Acute Diarrhea in Patients Receiving Pelvic Radiation-
Therapy
N01C3 The Efficacy of Lamotrigine in the Management of Chemotherapy-
InducedPeripheral Neuropathy: A Phase III Randomized, Double-
Blind,Placebo-Controlled Trial
N01C4 Phase III Double-Blind, Placebo-Controlled Randomized Comparison
ofZinc Sulfate Versus Placebo for the Prevention of Altered Taste inPa-
tients with Head and Neck Cancer During Radiation
N01C5 The Use of Valeriana Officinalis (Valerian) in Improving Sleep inPa-
tients Who Are Undergoing Treatment for Cancer: A Phase IIIRandom-
ized, Placebo-Controlled, Double-Blind Study
N01C8 Osteoporosis Prevention in Prostate Cancer Patients Receiving Andro-
genAblation Therapy: A Phase III Randomized, Placebo-Con-
trolled,Double-Blind Study
N01C9 Docetaxel and Infliximab/Placebo in Non-Small Cell Lung Cancer
(NSCLC)Patients >= 65 Years of Age or in NSCLC Patients With Poor
PerformancStatus: A Double-Blind, Randomized, Placebo-Controlled
Trial toPrevent and Treat Wasting, Anorexia, and Asthenia inChemo-
therapy-Naive and Previously-Treated
N01CB The Efficacy of Lidocaine Patch in the Management of Postsurgical-
Neuropathic Pain in Patients with Cancer: A Phase III Double-
Blind,Crossover Study
N02C1 A Phase III Randomized, Placebo-Controlled, Double-Blind Trial
ofRisedronate (Actonel) for Prevention of Bone Loss in Premenopausal-
Women Undergoing Chemotherapy for Primary Breast Carcinoma
CONTROL NCCTG CONTROL Committee Table of Contents - Page 3 of 4
Program Status Reports for CANCER CONTROL - September 2007
N02C3 The Use of Low Dose Testosterone to Enhance Libido in Female Can-
cerSurvivors: A Phase III Randomized, Placebo-Controlled, Double-
BlindCrossover Study
N03C5 A Phase III Randomized Trial of Gabapentin Alone or in Conjunction-
With an Antidepressant in the Management of Hot Flashes in Women
Whohave Inadequate Control with an Antidepressant Alone
N03CA The Use of American Ginseng (panax quinquefolius) to ImproveCancer-
Related Fatigue: A Randomized, Double Blind, Dose-Finding,Placebo-
Controlled Study
N03CC A Randomized, Controlled, Open-Label Trial of Empiric Prophylactic
vsDelayed Use of Zoledronic Acid for Prevention of Bone Loss inPost-
menopausal Women with Breast Cancer Initiating Therapy withLetro-
zole After Tamoxifen
CONTROL NCCTG CONTROL Committee Table of Contents - Page 4 of 4
NCCTG Status Report for Study N00CB - September 2007
A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapen-
tin in the Management of Hot Flashes in Men
Purpose of 1) To determine whether gabapentin can diminish hot-flashes for this study
Study: population.
2) To perform a dose-response evaluation of 3 gabapentin doses.
3) To determine the toxicity of low-dose gabapentin for the study population.
4) To evaluate whether patients are continuing therapy 6-24 months later &
whether they ascribe any toxicities to it.
5) To assess the impact of hot-flash activity on overall QOL & to examine
whether low doses of gabapentin can diminish this impact on QOL.
Study Chairs: Charles Lawrence Loprinzi M.D. QC Specialist: Monica B. Hansen
Bibi Swalehah Khoyratty M.D.
Statistician: Amylou Dueck Ph.D. Nurse Resource: Mary B. Wilwerding R.N.
Status: 12/14/2001 Activated Projected Number of Patients: 220
11/10/2006 Perm. Closed
Excluded: 9 Final Accrual: 223
Stratification No. of Hot Flashes Per Day Hot Flashes Duration
Factors:
Schema: Randomize
Gabapentin 300 mg hs x 28 days
Gabapentin 300 mg hs x 7 days
BID x 21 days
Gabapentin 300 mg hs x 7 days
BID x 7 days
TID x 14 days
Placebo x 28 days
Study Design: This is a phase III, randomized, double-blind, placebo-controlled trial to deter-
mine whether low doses of gabapentin can diminish hot-flash activity in men with a history of
prostate cancer.
Accrual: This study opened on 12/14/2001 and has accrued 223 patients. There are currently 8
patients who cancelled prior to receiving therapy, and 1 patient deemed ineligible out of the 223.
See accrual table for detail regarding specific site accrual.
Patient Characteristics: Patient characteristics are shown in the baseline characteristics table.
CONTROL NCCTG CONTROL Committee N00CB - Page 1 of 3
NCCTG Status Report for Study N00CB - September 2007
Adverse Events: Symptoms were rated on a 0-10 scale. Significant differences between arms
occurred in appetite loss and indigestion/belching.
Study Status: Study is permanently closed to accrual. Final manuscript is in development.
Additional Information: Results of this study were reported in an ASCO 2007 absract:
Loprinzi CL, Khoyratty BS, Dueck A, Barton DL, Jafar S, Rowland KM, Atherton PJ, Marsa
GW, Krook J, Kottschade L; North Central Cancer Treatment Group. Gabapentin for hot flashes
in men: NCCTG trial N00CB. ASCO 2007, Abstract 9005.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Allegheny WP 2 0 0
Ann Arbor 55 0 6
Bismarck 5 0 0
Carle 21 0 1
Cedar Rapids 2 0 1
Columbus 1 0 1
Des Moines 5 0 0
Duluth 19 0 0
Hawaii CCOP 1 0 0
Howard CCOP 1 0 0
Mayo 23 0 0
Mo Valley 11 0 0
Montana 3 0 1
Peoria 5 0 1
Rapid City 1 0 0
Scottsdale 15 0 0
Sioux City 8 0 0
Sioux Falls 2 0 0
St. Cloud 1 0 0
Toledo 19 0 2
Upstate Carol 15 0 4
Wichita 8 0 1
Total Membership Accrual 223 0 18
CONTROL NCCTG CONTROL Committee N00CB - Page 2 of 3
NCCTG Status Report for Study N00CB - September 2007
Baseline Characteristics Table:
Arm Arm Arm Arm
Characteristics
A B C D
Hot Flashes Duration
= 9 22 23 23 23
No. of Hot Flashes Per Day
2-3 5 5 10 8
4-9 28 29 24 24
10 + 23 21 21 25
Race
White 51 51 51 52
Black or African American 5 3 4 4
Asian 0 0 0 1
Not reported: patient refused or not ava 0 1 0 0
Toxicity Table: Mean Week 5 Minus Week 1 Patient Reported Symptoms
Symptom A B C D
Appetite Loss 0.18 -0.21 -0.09 0.42
Sleepiness -0.09 -0.58 -0.41 -0.32
Nausea 0.12 0 -0.14 0.02
Dizziness 0.51 0.14 0.39 0.24
Appetite Increase -0.24 -0.21 0.61 -0.07
Fatigue -0.19 -0.14 -0.75 0
Dry Mouth 0.41 -0.02 0.02 -0.04
Trouble Concentrating 0.07 -0.35 -0.16 0.16
Constipation -0.07 0.02 0.11 0.69
Trouble Walking/Balance 0 0.07 0.09 -0.16
Muscle Pain -0.09 0.16 0 0.09
Runny Nose -0.59 -0.09 0.09 -0.31
Trouble Sleeping -0.53 -0.63 -0.98 -1.32
Nervousness 0.05 -0.51 -0.36 -0.18
Mood Changes -0.04 -0.31 -0.40 -0.36
Sexual Relations 0.10 -0.05 0.98 0.26
Indigestion/Belching 0.29 -0.07 -0.64 0.05
Difficulty Achieving 0.22 -0.63 -0.29 -0.03
Orgasm 0.09 -0.12 -0.22 -0.22
Blurred Vision
CONTROL NCCTG CONTROL Committee N00CB - Page 3 of 3
NCCTG Status Report for Study N02C4 - September 2007
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Cre-
atine for Cancer-Associated Weight Loss
Purpose of 1) To compare creatine to placebo in the treatment of cancer-associated weight
Study: loss and anorexia. We propose to determine whether creatine results in an
increase in weight in advanced cancer patients who are suffering from loss
of weight and/or appetite.
2) To evaluate the effects of creatine compared to placebo on quality of life.
3) To evaluate possible toxicities related to creatine compared to placebo.
4) To explore whether treatment with creatine prolongs survival in a group of
cancer patients when compared to placebo alone.
5) To explore the effects of creatine on bioelectrical impedance in a subgroup
of patients.
Study Chairs: Aminah Jatoi M.D. QC Specialist: Linda M. Tetzlaff
Preston D. Steen M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Mary B. Wilwerding R.N.
Status: 12/17/2004 Activated Projected Number of Patients: 300
Excluded: 32 Final Accrual: NA
Stratification Age Group Concurrent Chemo
Factors: GBU Prog Index Gender
Location Primary Related Weight Loss
Schema: Randomize
Creatine
Placebo
Treating Schedule:
Arm Agent Dose Route Days Freq
CREATINE 20 grams (powder) Oral 1-5 (Loading dose)
CREATINE 2 grams (powder) Oral Daily starting day
6
PLACEB 20 grams (powder) Oral 1-5 (loading dose)
PLACEB 2 grams (powder) PO Daily starting day
6
Study Design: This is a randomized, double-blind, placebo-controlled Phase III study to com-
pare creatine to placebo in the treatment of cancer-associated weight loss and anorexia in
patients undergoing concurrent chemotherapy.
CONTROL NCCTG CONTROL Committee N02C4 - Page 1 of 5
NCCTG Status Report for Study N02C4 - September 2007
Accrual: This study opened on 12/17/2004 with an accrual goal of 274, due the large number of
canceled patients the accrual goal has been increased to 300 patients (150 per arm). 275 patients
have been accrued as of 08/06/2007.
Patient Characteristics: The distribution of patient characteristics at study entry is located in
the Patient Characteristics table.
Available Information: There have been twenty-seven canceled patients (mostly due to patient
and/or M.D. decision) and one ineligible patient on this study.
Adverse Events: There has been four grade 5 adverse events reported, all of which were
deemed unlikely to have been caused by the study treatment. There was sixteen grade 4 adverse
events all of which were deemed not or unlikely related to the study treatment. See adverse event
table.
Study Status: This study continues to accrue patients. Since the last NCCTG book report,
approximately 9 patients have been accrued per month. At this rate, the accrual goal of 300
patients will be reached in another three months.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Allegheny WP 2 0 1
Ann Arbor 7 0 0
Carle 33 7 12
Columbus 4 4 4
Des Moines 1 0 1
Duluth 13 2 3
Fargo 4 1 1
Geisinger 26 9 10
Georgia CCOP 1 0 0
Green Bay 16 3 12
Hawaii CCOP 2 0 1
Heartland 6 2 4
Jacksonville 1 0 0
Lehigh 5 1 1
Mayo 6 0 1
Metro MN 4 0 2
Mo Valley 14 1 7
Montana 9 3 4
N Indiana 7 7 7
Peoria 29 2 6
Scottsdale 3 1 1
CONTROL NCCTG CONTROL Committee N02C4 - Page 2 of 5
NCCTG Status Report for Study N02C4 - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Sioux Falls 4 0 2
Toledo 8 0 1
Wichita 70 12 34
Total Membership Accrual 275 55 115
CONTROL NCCTG CONTROL Committee N02C4 - Page 3 of 5
NCCTG Status Report for Study N02C4 - September 2007
Baseline Characteristics Table:
Arm Arm
Characteristics
A B
Age Group
=50 121 124
Concurrent Chemo
Yes 108 110
No 28 29
GBU Prog Index
GOOD 12 10
BAD 25 29
UNSURE 99 100
Gender
Female 49 51
Male 87 88
Primary Tumor Site
Lung 49 52
GI 35 30
Other 52 57
Race
White 127 126
Black or African American 8 9
Asian 0 3
American Indian or Alaska Native 1 1
Related Weight Loss
=4.6 KG 72 74
CONTROL NCCTG CONTROL Committee N02C4 - Page 4 of 5
NCCTG Status Report for Study N02C4 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 88
Arm B Evaluable Patients: 92
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 0 0 0 0 0 0 0 0
B 0 0 3 3 3 3 0 0
LEUKOPENIA A 0 0 0 0 0 0 0 0
B 0 0 4 4 3 3 0 0
ANEMIA A 0 0 1 1 0 0 0 0
B 3 3 0 0 1 1 0 0
THROMBOCYTOPENIA A 0 0 0 0 0 0 0 0
B 1 1 0 0 3 3 0 0
Gastrointestinal NAUSEA A 33 38 7 8 0 0 0 0
B 32 35 1 1 0 0 0 0
CONSTIPATION A 31 35 0 0 0 0 0 0
B 27 29 1 1 0 0 0 0
Hemorrhage HEMORRHAGE-CNS A 0 0 0 0 1 1 0 0
B 0 0 0 0 0 0 0 0
Hepatic BILIRUBIN A 0 0 1 1 1 1 0 0
B 0 0 0 0 0 0 0 0
Neurology PERSONALITY CHANGE A 0 0 0 0 1 1 0 0
B 0 0 0 0 0 0 0 0
Pain PAIN-ABDOMINAL A 25 28 4 5 0 0 0 0
B 24 26 4 4 0 0 0 0
Pulmonary DYSPNEA A 23 26 9 10 2 2 0 0
B 26 28 10 11 1 1 1 1
Death DEATH NOS A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 1 1
DISEASE PROGRESSION A 0 0 0 0 0 0 1 1
B 0 0 0 0 0 0 1 1
Maximum Grade Adverse Event A 43 49 23 26 5 6 1 1
B 37 40 25 27 5 5 3 3
CONTROL NCCTG CONTROL Committee N02C4 - Page 5 of 5
NCCTG Status Report for Study N03CB - September 2007
An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for
Gefitinab- or Cetuximab- Induced Skin Rash (or Other Epidermal Growth
Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)
Purpose of 1) To compare the incidence and severity of rash development during the first
Study: month in gefitinab-treated patients who receive tetracycline versus placebo.
2) To explore the toxicity of tetracycline versus placebo in this setting.
3) To explore quality of life issues faced by gefitinab-treated patients who
develop a rash versus those who do not develop a rash.
4) To explore whether discontinuation of tetracycline at one month is followed
by rash development.
Study Chairs: Aminah Jatoi M.D. QC Specialist: Monica B. Hansen
James A. Mailliard M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Mary B. Wilwerding R.N.
Status: 12/17/2004 Activated Projected Number of Patients: 126
Excluded: 4 Final Accrual: NA
Stratification Chemotherapy regimen
Factors: EGFR inhibitor
Corticosterioid use
Schema: Register
A) Tetracycline
B) Placebo
Treating Schedule:
Arm Agent Dose Route Days Freq
Tetracycline 500 mg (two 250 Oral BID BID x 4 weeks
mg capsules)
Placebo 2 capusles Oral BID BID x 4 weeks
Study Design: This is an exploratory, placebo-controlled trial to compare the incidence and
severity of rash development during the first month in gefitinib-treated patients who receive tet-
racycline versus placebo.
Accrual: This study was opened on 12/17/2004 and was closed to accrual on 7/8/2005 with a
final accrual of 65 patients out of an intended 66. The study was reopened on 6/22/2007 to
accrue an additional 60 patients and has accrued two patients as of 8/6/2007. There have been a
total of four patient cancellations.
CONTROL NCCTG CONTROL Committee N03CB - Page 1 of 4
NCCTG Status Report for Study N03CB - September 2007
Patient Characteristics: Patient characteristics are available in the Baseline Characteristics
Table.
Adverse Events: Three patients on the Tetracycline arm reported Grade 4 and 5 toxicities. The
Grade 5 disease progression and Grade 5 pneumonitis were deemed not related to treatment.
The Grade 4 hypersensitivity was deemed unlikely related to treatment.
Study Status: This study reopened on 6/22/2007 and is accruing per protocol.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Ann Arbor 2 0 0
Bismarck 1 0 0
Carle 8 0 0
Dayton 9 0 0
Des Moines 2 0 0
Duluth 6 0 0
Fargo 5 2 2
Metro MN 1 0 0
Mo Valley 2 0 0
Montana 1 0 0
Peoria 6 0 0
Rapid City 1 0 0
Sioux City 6 0 0
Sioux Falls 5 0 0
Toledo 6 0 0
Wichita 6 0 0
Total Membership Accrual 67 2 2
Baseline Characteristics Table:
Arm Arm
Characteristics
A B
Corticosteroid Therapy
Yes 7 7
No 27 26
EGFR Inhibitor
Gefitinab 3 5
Cetuximab 13 13
Other 18 15
CONTROL NCCTG CONTROL Committee N03CB - Page 2 of 4
NCCTG Status Report for Study N03CB - September 2007
Arm Arm
Characteristics
A B
Gender
Male 18 24
Female 16 9
Potentially Curable Cancer
Yes 4 3
No 30 30
Race
White 33 31
Black or African American 1 2
Chemotherapy Regimen
First-line chemotherapy 12 12
Other 22 21
Type of cancer
Lung 19 15
Gastrointestinal 8 10
Other 7 8
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 27
Arm B Evaluable Patients: 29
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Allergy/Immunology HYPERSENSITIVITY A 0 0 0 0 1 4 0 0
B 0 0 0 0 0 0 0 0
Dermatology/Skin RASH A 16 59 1 4 0 0 0 0
B 23 79 0 0 0 0 0 0
Gastrointestinal NAUSEA A 11 41 0 0 0 0 0 0
B 10 34 1 3 0 0 0 0
VOMITING A 8 30 0 0 0 0 0 0
B 5 17 1 3 0 0 0 0
DIARRHEA-NO COLOSTOM A 5 19 1 4 0 0 0 0
B 8 28 1 3 0 0 0 0
Pain PAIN-STOMACH A 4 15 1 4 0 0 0 0
B 8 28 1 3 0 0 0 0
Pulmonary PNEUMONITIS A 0 0 0 0 0 0 1 4
B 0 0 0 0 0 0 0 0
Death DISEASE PROGRESSION A 0 0 0 0 0 0 1 4
B 0 0 0 0 0 0 0 0
Maximum Grade Adverse Event A 17 63 4 15 1 4 2 7
CONTROL NCCTG CONTROL Committee N03CB - Page 3 of 4
NCCTG Status Report for Study N03CB - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
B 24 83 5 17 0 0 0 0
CONTROL NCCTG CONTROL Committee N03CB - Page 4 of 4
NCCTG Status Report for Study N04C2 - September 2007
An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide
(Sandostatin LAR Depot ) for Symptomatic Ascites in Cancer Patients
Purpose of 1) Determine whether depot octreotide is effective in extending the time-to-
Study: paracentesis for cancer patients with symptomatic, malignant ascites.
2) To explore whether octreotide will reduce the nmber of paracenteses.
3) Determine whether depot octreotide can reduce VEGF concentrations in
ascitic fluid.
4) To assess quality of life, as it relates to the presence of ascites and to the use
of depot octreotide in this setting.
5) To provide blood samples from ovarian cancer patients to help in the valida-
tion of the LPA assay.
Study Chairs: Aminah Jatoi M.D. QC Specialist: Monica B. Hansen
Paul L. Schaefer M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Mary B. Wilwerding R.N.
Status: 10/28/2005 Activated Projected Number of Patients: 68
Excluded: None Final Accrual: NA
Stratification Current Therapy Prior Paracentesis Frequency
Factors: Prior Chemotherapy
Schema: Randomize
Octreotide/Placebo
Treating Schedule:
Arm Agent Dose Route Days Freq
Octreotide / Pla- 100 mcg/1mL SQ Day 1 one time
cebo
Octreotide / Pla- 30 mg IM Day 2 Monthly
cebo
Study Design: This is an exploratory, randomized, double-blind, placebo-controlled study
designed to determine the effects of depot octreotide in extending the time-to-paracentesis for
cancer patients with symptomatic, malignant ascites.
Accrual: This study opened on October 28, 2005 and has accrued 12 patients as of August 6,
2007. Four patients have accrued in the last 6 months.
Patient Characteristics: See patient characteristics table.
CONTROL NCCTG CONTROL Committee N04C2 - Page 1 of 3
NCCTG Status Report for Study N04C2 - September 2007
Adverse Events: One patient from arm A had Grade 5 disease progression and one patient from
arm B had Grade 4 pain-abdominal. Both of these were deemed as being unrelated to the treat-
ment agent. There have been seven grade 3 adverse events: 1 neutropenia arm A, 1 fistula-rectal
arm A, 1 dehydration arm A, 1 diarrhea-no colostom arm A, 1 bilirubin arm A, 1 pain-abdomi-
nal arm B and 1 creatinine arm A. See Adverse Event table.
Study Status: Patient accrual and treatment are continuing.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Bismarck 4 1 2
Mayo 4 2 3
Montana 2 0 1
St. Cloud 1 1 1
Wichita 1 0 1
Total Membership Accrual 12 4 8
Baseline Characteristics Table:
Arm Arm
Characteristics
A B
Current Therapy
Yes 3 3
No 3 3
Gender
Female 5 4
Male 1 2
Liver Metastases(>25% of Liver
Yes 2 1
No 4 5
Ongoing diurectic therapy anti
Yes 1 3
No 5 3
Prior Chemotherapy
Only first-line chemotherapy 1 3
Second-line chemotherapy 3 1
Other 2 2
Prior Paracentesis Frequency
Other 6 6
Race
CONTROL NCCTG CONTROL Committee N04C2 - Page 2 of 3
NCCTG Status Report for Study N04C2 - September 2007
Arm Arm
Characteristics
A B
White 5 6
American Indian or Alaska Native 1 0
Type of cancer
Ovarian cancer 1 0
Primary peritoneal cancer 1 1
Gastrointestinal cancer 1 0
Other 3 5
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 4
Arm B Evaluable Patients: 3
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 0 0 1 25 0 0 0 0
B 0 0 0 0 0 0 0 0
Gastrointestinal FISTULA-RECTAL A 0 0 1 25 0 0 0 0
B 0 0 0 0 0 0 0 0
DEHYDRATION A 0 0 1 25 0 0 0 0
B 0 0 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 0 0 1 25 0 0 0 0
B 0 0 0 0 0 0 0 0
Hepatic BILIRUBIN A 0 0 1 25 0 0 0 0
B 0 0 0 0 0 0 0 0
Pain PAIN-ABDOMINAL A 2 50 0 0 0 0 0 0
B 0 0 1 33 1 33 0 0
Renal /Genitourinary CREATININE A 0 0 1 25 0 0 0 0
B 0 0 0 0 0 0 0 0
Death DISEASE PROGRESSION A 0 0 0 0 0 0 1 25
B 0 0 0 0 0 0 0 0
Maximum Grade Adverse Event A 1 25 2 50 0 0 1 25
B 1 33 1 33 1 33 0 0
CONTROL NCCTG CONTROL Committee N04C2 - Page 3 of 3
NCCTG Status Report for Study N04C7 - September 2007
A Phase III Randomized, Placebo-Controlled, Double Blind Study of Intrave-
nous Calcium/Magnesium to Prevent Oxaliplatin-Induced Sensory Neurotox-
icity
Purpose of 1) To determine whether CaMg infusions can prevent or ameliorate chronic,
Study: cumulative neurotoxicity associated with oxaliplatin.
2) To determine whether CaMg infusions can increase the cumulative oxalipl-
atin doses that can be delivered without chronic neurotoxicity.
3) To determine whether CaMg infusions can ameliorate the acute neuropathy
associated with oxaliplatin.
4) To determine whether CaMg infusions cause any adverse events.
5) To investigate whether CaMg infusions influence quality of life, fatigue, and
activities of daily living (ADLs).
6) To determine if polymorphisms in the GSTP1 gene predict for early onse of
oxaliplatin-induced neurotoxicity.
Study Chairs: Axel Grothey M.D. QC Specialist: Monica B. Hansen
Daniel A. Nikcevich M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Mary B. Wilwerding R.N.
Status: 01/13/2006 Activated Projected Number of Patients: 300
06/19/2007 Perm. Closed
Excluded: None Final Accrual: 104
Stratification Age (years) Gender
Factors: Regimen
Schema: Randomize
Calcium gluconate plus magnesium sulfate immediately before and
after chemotherapy.
Placebo immediately before and after chemotherapy.
Treating Schedule:
Arm Agent Dose Route Days Freq
Calcium glucon- 1 g of each agent IV in 100 ml D5W over 30 Immediately
ate plus magne- minutes before & after
sium sulfate each oxaliplatin
administration
Placebo 100 ml bag of IV over 30 minutes Immediately
D5W before & after
each oxaliplatin
administration
CONTROL NCCTG CONTROL Committee N04C7 - Page 1 of 4
NCCTG Status Report for Study N04C7 - September 2007
Study Design: This is a phase III, randomized, placebo-controlled, double-blind trial to deter-
mine whether intravenous calcium/magnesium will prevent oxaliplatin-induced sensory neuro-
toxicity in patients with confirmed adenocarcinoma of the colon.
Accrual: This study has had an accrual of 104 patients thus far. Fifty-three patients have been
accrued in the last 6 months. See Accrual Table.
Patient Characteristics: The distribution of patient characteristics at study entry is located in
the Baseline Characteristics Table.
Adverse Events: Three patients reported a Grade 4 Neutropenia, two patients reported Grade 4
Hyponatremia, and one patient reported a Grade 4 Hypokalemia. Two of the three Grade 4 Neu-
tropenia and the Grade 4 Hypokalemia were attributed to the medication, whereas the remaining
three Grade 4 toxicities were not attributed. See Toxicity Table.
Study Status: Based on preliminary evaluation of response data from cancer treatment trial
L_9444 indicating a significant decrease response rate observed in patients treated with CaMg
infusions compared with patients on placebo, this study was permanently closed to patient
accrual effective 06/19/2007.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Ann Arbor 4 2 4
Bismarck 1 1 1
Carle 3 1 3
Des Moines 3 1 1
Duluth 7 2 5
Georgia CCOP 1 1 1
Grand Forks 9 3 8
Green Bay 3 1 3
Heartland 5 2 5
Mayo 17 11 14
Mo Valley 10 5 9
Montana 3 3 3
N Indiana 4 3 4
Oklahoma 5 3 5
Peoria 11 5 10
Sioux City 7 2 7
Sioux Falls 2 2 2
St. Cloud 6 3 4
Toledo 1 1 1
Upstate Carol 2 1 2
CONTROL NCCTG CONTROL Committee N04C7 - Page 2 of 4
NCCTG Status Report for Study N04C7 - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Total Membership Accrual 104 53 92
Baseline Characteristics Table:
Arm Arm
Characteristics
A B
Age Group
=65 19 19
Gender
Male 29 27
Female 23 25
Oral calcium/magnesium supplem
Yes 10 10
No 42 42
Race
White 50 50
Black or African American 1 1
American Indian or Alaska Native 0 1
Not reported: patient refused or not ava 1 0
Regimen
FOLFOX4 3 3
Modified FOLFOX6 49 49
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 21
Arm B Evaluable Patients: 22
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 0 0 3 14 2 10 0 0
B 2 9 2 9 2 9 0 0
Cardiovascular THROMBOSIS A 0 0 2 10 0 0 0 0
B 0 0 1 5 1 5 0 0
Constitutional Symptoms FATIGUE A 2 10 0 0 0 0 0 0
B 4 18 2 9 0 0 0 0
Gastrointestinal NAUSEA A 15 71 0 0 0 0 0 0
B 14 64 3 14 0 0 0 0
CONSTIPATION A 8 38 0 0 0 0 0 0
B 7 32 0 0 0 0 0 0
CONTROL NCCTG CONTROL Committee N04C7 - Page 3 of 4
NCCTG Status Report for Study N04C7 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
VOMITING A 7 33 0 0 0 0 0 0
B 6 27 2 9 0 0 0 0
DIARRHEA-NO COLOSTOM A 11 52 1 5 0 0 0 0
B 11 50 3 14 0 0 0 0
Metabolic/Laboratory HYPOKALEMIA A 0 0 0 0 1 5 0 0
B 0 0 1 5 0 0 0 0
HYPERMAGNESEMIA A 5 24 0 0 0 0 0 0
B 7 32 0 0 0 0 0 0
Neurology NEURO-SENSORY A 1 5 3 14 0 0 0 0
B 5 23 2 9 0 0 0 0
Maximum Grade Adverse Event A 10 48 6 29 3 14 0 0
B 8 36 9 41 3 14 0 0
CONTROL NCCTG CONTROL Committee N04C7 - Page 4 of 4
NCCTG Status Report for Study N04CA - September 2007
Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Pla-
cebo-Controlled Study
Purpose of - Primary Goal
Study: 1) To determine the effectiveness of pilocarpine for alleviation of vaginal dry-
ness.
- Secondary Goal
1) To evaluate any toxicities arising from pilocarpine in this patient population.
2) To evaluate quality of life in these patients treated with pilocarpine.
Study Chairs: Charles Lawrence Loprinzi M.D. QC Specialist: Monica B. Hansen
Ernie Porteza Balcueva M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Anne Forsman
R.N.,BSN,OCN
Status: 12/15/2006 Activated Projected Number of Patients: 192
Excluded: None Final Accrual: NA
Stratification Age Current tamoxifen therapy
Factors: Concurrent aromatase inhibitor use Baseline severity of vaginal symptoms
Schema: Randomization
Pilocarpine 2x/day
Pilocarpine 4x/day
Placebo 2x/day
Placebo 4x/day
Treating Schedule:
Arm Agent Dose Route Days Freq
* Pilocarpine (64 5 mg capsule Oral 2 times a day 6 weeks
patients)/Placebo
(32 patients)
* Pilocarpine (64 5 mg capsule Oral 4 times a day 6 weeks
patients)/Placebo
(32 patients)
* Patients will be titrated to their target dose (pilocarpine or
placebo), by starting with 1 capsule daily and will increase by 1
capsule every 3 days to their target dose (either two times or four
times a day).
CONTROL NCCTG CONTROL Committee N04CA - Page 1 of 4
NCCTG Status Report for Study N04CA - September 2007
Study Design: This is a randomized, phase III, double-blind, placebo-controlled study designed
to determine the effectiveness of pilocarpine for alleviation of vaginal dryness.
Accrual: This study is opened on 12/15/2006 and has accrued 37 patients as of August 6, 2007.
Patient Characteristics: See patient characteristics table.
Adverse Events: One patient from arm C had grade 3 dizziness that was probably related to
treatment drug. See adverse event table.
Study Status: Patient accrual and treatment are continuing.
Accrual Table:
Randomizing Total
Membership Entered
Ann Arbor 4
Carle 4
Cedar Rapids 1
Columbus 1
Duluth 1
Fargo 4
Green Bay 1
Mo Valley 5
N Indiana 5
Peoria 1
Sioux City 2
Wichita 8
Total Membership Accrual 37
Baseline Characteristics Table:
Arm Arm Arm Arm
Characteristics
A B C D
Age Group
18-45 1 1 1 1
46-55 5 2 6 3
56-65 5 2 5 3
>65 0 1 1 0
BREAST CANCER HISTORY
1 8 4 12 4
2 3 2 1 3
CONTROL NCCTG CONTROL Committee N04CA - Page 2 of 4
NCCTG Status Report for Study N04CA - September 2007
Arm Arm Arm Arm
Characteristics
A B C D
Current Aromatase Inhibitor
Yes 6 3 8 4
No 5 3 5 3
Gender
f 11 6 13 7
Prior Adjuvant Rx
Yes 7 4 9 3
No 4 2 4 4
Prior Hormonal Therapy
Yes 8 4 7 4
No 3 2 6 3
Race
White 11 6 13 7
Severity of Vaginal Symptoms
Mild 0 0 2 0
Moderate 6 3 7 4
Severe 5 3 4 3
Tamoxifen
Yes 2 0 2 0
No 9 6 11 7
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 7
Arm B Evaluable Patients: 4
Arm C Evaluable Patients: 7
Arm D Evaluable Patients: 3
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Allergy/Immunology RHINITIS ALLERGIC A 2 29 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 3 43 0 0 0 0 0 0
D 1 33 0 0 0 0 0 0
Constitutional Symptoms RIGORS A 1 14 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 2 29 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
SWEATING A 3 43 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 4 57 0 0 0 0 0 0
D 2 67 0 0 0 0 0 0
CONTROL NCCTG CONTROL Committee N04CA - Page 3 of 4
NCCTG Status Report for Study N04CA - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Gastrointestinal NAUSEA A 2 29 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 2 29 0 0 0 0 0 0
D 1 33 0 0 0 0 0 0
GASTROINTESTINAL A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 1 14 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
SALIVARY GLAND A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 1 14 0 0 0 0 0 0
D 0 0 0 0 0 0 0 0
Neurology DIZZINESS A 2 29 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 1 14 1 14 0 0 0 0
D 1 33 0 0 0 0 0 0
Renal /Genitourinary URINARY FREQUENCY A 2 29 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 3 43 0 0 0 0 0 0
D 1 33 0 0 0 0 0 0
Maximum Grade Adverse Event A 5 71 0 0 0 0 0 0
C 4 57 1 14 0 0 0 0
D 3 100 0 0 0 0 0 0
CONTROL NCCTG CONTROL Committee N04CA - Page 4 of 4
NCCTG Status Report for Study N05C3 - September 2007
The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral
Neuropathy: A Phase III Double-Blind Placebo Controlled Study
Purpose of - Primary Goal
Study: 1) To compare the incidence of CIPN greater than or equal to grade 2 sensory
neuropathy between the groups treated with Vitamin E and placebo at the
end of adjuvant treatment.
- Secondary Goals
1) To compare the proportion of patients requiring dose reductions of chemo-
therapy secondary to peripheral neuropathy between the 2 arms.
2) To compare the proportion of patients stopping chemotherapy before treat-
ment is complete secondary to peripheral neuropathy between the 2 arms.
3) To assess the toxicity of Vitamin E in this situation.
Study Chairs: Lisa A. Kottschade RN,MSN,CNP QC Specialist: Linda M. Tetzlaff
Miroslaw A. Mazurczak M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Mary L Collins R.N.,
MSN, OCN
Status: 12/01/2006 Activated Projected Number of Patients: 200
Excluded: 5 Final Accrual: NA
Stratification Type of chemotherapy Age
Factors: Gender
Schema: Randomize
Vitamin E
Placebo
Treating Schedule:
Arm Agent Dose Route Days Freq
- Vitamin E/Placebo 300 mg PO Twice daily Start 50 29 28
Chemotherapy Rx
CONTROL NCCTG CONTROL Committee N05C3 - Page 2 of 3
NCCTG Status Report for Study N05C3 - September 2007
Arm Arm
Characteristics
A B
Taxane 27 26
Cisplatinum 1 2
Carboplatin 2 2
Oxaliplatin 15 14
Combination 8 8
Gender
f 43 42
m 10 10
Num of Cycles
4 31 27
Primary Tumor Site
Breast 28 30
Lung 1 4
Other 24 18
Race
White 49 48
Black or African American 2 2
Asian 1 0
American Indian or Alaska Native 0 1
Not reported: patient refused or not ava 1 1
CONTROL NCCTG CONTROL Committee N05C3 - Page 3 of 3
NCCTG Status Report for Study N05C4 - September 2007
A Phase III, Randomized, Double-blind, Placebo-Controlled Trial of Prophy-
lactic Topical Sunscreen to Prevent Erlotinib- or Cetuximab-Induced Skin
Rash [or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-
Induced Skin Rash]
Purpose of 1) To compare the incidence and severity of rash development during the first 4
Study: weeks in epidermal growth factor receptor inhibitor-treated patients who
receive topical sunscreen versus placebo.
2) To explore the toxicity of topical sunscreen versus placebo in this setting.
3) To explore whether discontinuation of topical sunscreen at 4 weeks is fol-
lowed by rash development.
Study Chairs: Aminah Jatoi M.D. QC Specialist: Monica B. Hansen
Abby R. Thrower M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Mary B. Wilwerding R.N.
Status: 10/13/2006 Activated Projected Number of Patients: 110
06/13/2007 Perm. Closed
Excluded: 2 Final Accrual: 116
Stratification Cancer therapy regimen EGFR inhibitor
Factors: Sun Hypersensitivity Meds Sex
Schema: Randomization
Suncreen SPF
Placebo
Treating Schedule:
Arm Agent Dose Route Days Freq
- Topical Sunscreen/ Apply generously Topical BID 4 weeks
placebo to face, trunk, and
extremities twice a
day
*In the event of water exposure or other event that prompts
reapplication, the patient should reapply sunscreen after drying the
skin.
**It is recommended that sunscreen be applied early in the morning and
mid-day; a third application is encouraged if sunscreen exposure is
likely to occur in the evening.
CONTROL NCCTG CONTROL Committee N05C4 - Page 1 of 4
NCCTG Status Report for Study N05C4 - September 2007
Study Design: This is a randomized, phase III, double-blind, placebo-controlled study designed
to compare incidence of rash development between sunscreen-treated and placebo exposed
patients.
Accrual: This study opened on 10/13/2006 and was permanently closed on 06/13/2007. It
accrued 116 out of a targeted 110 patients. There were 2 exclusions. See Accrual Table.
Patient Characteristics: See Patient Characteristics Table.
Adverse Events: Toxicity information is avaliable for 86 patients as of 08/06/2007. One patient
from the treatment arm reported a Grade 5 adverse event (Disease Progression) and two Grade 4
adverse events (Pleural Effusion and Thrombosis). All three adverse events were not related to
the study medication. See Toxicity Table.
Study Status: This trial is closed to patient accrual. All patients should be off-study by the Sep-
tember DMC Meeting. Data entry is on-going.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Ann Arbor 5 4 5
Carle 1 1 1
Cedar Rapids 3 1 3
Dayton 4 4 4
Des Moines 5 4 5
Duluth 7 6 7
Fargo 3 3 3
Geisinger 3 3 3
Green Bay 4 3 4
Heartland 1 0 1
Mayo 8 4 8
Metro MN 23 16 23
Mo Valley 4 4 4
N Indiana 4 4 4
Peoria 5 4 5
Rapid City 1 1 1
Sioux City 3 2 3
Toledo 2 2 2
Upstate Carol 3 3 3
Wichita 27 19 27
Total Membership Accrual 116 88 116
CONTROL NCCTG CONTROL Committee N05C4 - Page 2 of 4
NCCTG Status Report for Study N05C4 - September 2007
Baseline Characteristics Table:
Arm Arm
Characteristics
A B
EGFR Inhibitor
Small molecule (i.e. erlotinib) 23 23
Monoclonal antibodies (cetuximab) 35 35
EGFR Treatment
Erlotinib 19 21
Cetuximab 30 30
Panitumumab 6 6
Other 3 1
Ethnicity
Caucasian 57 55
Asian American 1 1
African American 0 2
Gender
Male 28 28
Female 30 30
Location Zone
Zone 1 31 33
Zone 2 27 25
Performance Score
0 30 32
1 24 24
2 3 1
3 1 1
Potentially Curable Cancer
Yes 8 11
No 50 47
Race
White 57 55
Black or African American 0 3
Asian 1 0
Rx Regimen
First-line cancer therapy 19 19
Other 39 39
Season
Spring 34 34
Fall 1 2
Winter 23 22
Sun Hypersensitivity Meds
Yes 20 21
No 38 37
Taking topical/oral antibiotic
CONTROL NCCTG CONTROL Committee N05C4 - Page 3 of 4
NCCTG Status Report for Study N05C4 - September 2007
Arm Arm
Characteristics
A B
Yes 6 4
No 52 54
Taking topical/oral corticoste
Yes 12 8
No 46 50
Type of cancer
LUNG 24 18
GASTROINTESTINAL 23 23
OTHER 11 17
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 46
Arm B Evaluable Patients: 51
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Cardiovascular THROMBOSIS A 0 0 1 2 1 2 0 0
B 0 0 1 2 0 0 0 0
Pulmonary EFFUSION-PLEURAL A 0 0 0 0 1 2 0 0
B 0 0 0 0 0 0 0 0
Death DISEASE PROGRESSION A 0 0 0 0 0 0 1 2
B 0 0 0 0 0 0 0 0
Maximum Grade Adverse Event A 29 63 9 20 0 0 1 2
B 29 57 16 31 0 0 0 0
CONTROL NCCTG CONTROL Committee N05C4 - Page 4 of 4
NCCTG Status Report for Study N05C5 - September 2007
A Phase III Randomized , Placebo-controlled, Double-blind Trial to Determine
the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and
Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syn-
drome
Purpose of 1) To determine whether the prophylactic use of a topical urea/lactic acid
Study: cream can decrease the incidence/severity of capecitabine-caused palmar-
plantar erythrodysesthesia (main effect #1).
2) To evaluate the potential toxicity of this hand cream.
3) To determine whether the prophylactic use of vitamin B6 can decrease the
incidence and/or severity of capecitabine-caused palmar-plantar erythrodys-
esthesia (main effect #2).
4) To evaluate the potential toxicity of vitamin B6.
5) To determine whether the prophylactic use of a topical urea/lactic acid
cream in combination with vitamin B6 can decrease the incidence and/or
severity of capecitabine-caused palmar-plantar erythrodysesthesia.
Study Chairs: Charles Lawrence Loprinzi M.D. QC Specialist: Linda M. Tetzlaff
Jeffrey L. Berenberg M.D.
Statistician: Jeff A. Sloan Ph.D. Nurse Resource: Mary B. Wilwerding R.N.
Status: 06/23/2006 Activated Projected Number of Patients: 264
Excluded: 1 Final Accrual: NA
Stratification Age Sex
Factors: Capecitabine dose level Cancer type
Therapy type
Schema: Randomization
Urea/Lactic Acid-based cream (Vitamin B6)
Urea/Lactic Acid-based cream (Placebo capsule)
Placebo Cream (Vitamin B6)
Placebo Cream (Placebo capsule)
Treating Schedule:
Arm Agent Dose Route Days Freq
- Urea/lactic acid- 1/2 - 1 tsp. Topical 21 days 2 times per day
based cream/Pla-
cebo cream
- Vitamin B6/Pla- 200 mg Oral 21 days 1 capsule per day
cebo
Treatment schedule continues for 4 cycles
CONTROL NCCTG CONTROL Committee N05C5 - Page 1 of 4
NCCTG Status Report for Study N05C5 - September 2007
Study Design: This is a four-arm, randomized, double-blinded trial involving a 2x2 factorial
design to determine the effectiveness of a Urea/Lactic acid-based topical Keratolytic agent and
vitamin B-6 for prevention of Capecitabine-induced hand and foot syndrome.
Accrual: This study was activated on 6/23/2006. As of 8/13/2007, 42 patients have been
enrolled at 17 memberships.
Patient Characteristics: See patient characteristics table.
Adverse Events: As of 8/13/2007, no grade 4 or 5 events have been reported. One patient in
arm C had a grade 3 treatment related diarrhea.
Study Status: Patient accrual and treatment are continuing per protocol.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Carle 1 1 1
Cedar Rapids 1 0 1
Fargo 2 2 2
Geisinger 1 1 1
Grand Forks 1 1 1
Green Bay 2 2 2
Heartland 4 1 4
Mayo 7 2 6
Metro MN 10 2 10
Montana 1 0 1
N Indiana 2 2 2
Oklahoma 1 0 1
Peoria 3 1 3
Sioux City 2 2 2
St. Cloud 1 1 1
Toledo 2 2 2
Upstate Carol 1 0 1
Total Membership Accrual 42 20 41
Baseline Characteristics Table:
CONTROL NCCTG CONTROL Committee N05C5 - Page 2 of 4
NCCTG Status Report for Study N05C5 - September 2007
Arm Arm Arm Arm
Characteristics
A B C D
Age Group
60 5 5 5 5
Cancer Type
Breast 7 7 7 6
Colon 4 3 3 4
Lung 0 1 0 0
Capecitabine Dose Level
2000mg/m^2 per day(1000mg/m^2 BID) 9 9 9 9
2500mg/m^2 per day(1250mg/m^2 BID) 2 2 1 1
Gender
Male 2 3 3 2
Female 9 8 7 8
Race
White 11 11 10 9
Black or African American 0 0 0 1
Therapy Type
Adjuvant 1 2 1 1
Metastatic 10 9 9 9
Adverse Event Table:
Evaluable for Toxicity: Arm A = 4, Arm B = 8, Arm C = 8, Arm D = 2
Maximum Severity Per Patient
Adverse Event Arm Grade 1 Grade 2 Grade 3 Grade 4
N % N % N % N %
ABD Distention A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 13 0 0 0 0
D 0 0 0 0 0 0 0 0
Coagulation A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 1 13 0 0
D 0 0 0 0 0 0 0 0
CONTROL NCCTG CONTROL Committee N05C5 - Page 3 of 4
NCCTG Status Report for Study N05C5 - September 2007
Maximum Severity Per Patient
Adverse Event Arm Grade 1 Grade 2 Grade 3 Grade 4
N % N % N % N %
Diarrhead-No Colostom A 0 0 1 25 0 0 0 0
B 1 13 1 13 0 0 0 0
C 3 38 1 13 1 13 0 0
D 0 0 1 50 0 0 0 0
Fatigue A 0 0 0 0 0 0 0 0
B 0 0 1 13 0 0 0 0
C 0 0 2 25 0 0 0 0
D 0 0 0 0 0 0 0 0
Hyponatremia A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 1 13 0 0
D 0 0 0 0 0 0 0 0
LWR GI Hemmorage A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 0 0 1 13 0 0
D 0 0 0 0 0 0 0 0
Weight Loss A 0 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
C 0 0 1 13 0 0 0 0
D 0 0 0 0 0 0 0 0
Worst Adverse Event A 0 0 1 25 0 0 0 0
B 1 13 2 25 0 0 0 0
C 3 38 1 13 2 25 0 0
D 0 0 1 50 0 0 0 0
CONTROL NCCTG CONTROL Committee N05C5 - Page 4 of 4
NCCTG Status Report for Study N05C9 - September 2007
Phase III Randomized, Double-blind, Placebo-controlled Evaluation of Citalo-
pram for the Treatment of Hot Flashes
Purpose of 1) To evaluate the efficacy of three different doses of citalopram on hot flash
Study: scores in women with a history of breast cancer or women who do not wish
to take estrogen therapy for fear of increased risk of breast cancer.
2) To evaluate the side effect profile of three different doses of citalopram in
this study population.
3) To evaluate the effect of three different doses of citalopram on the secondary
outcome of mood and interference of activities from hot flashes.
4) To determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of
various doses of citalopram.
Study Chairs: Debra L. Barton Ph.D. QC Specialist: Monica B. Hansen
Statistician: Jeff A. Sloan Ph.D. Nurse Resource:
Status: 11/03/2006 Activated Projected Number of Patients: 220
04/13/2007 Perm. Closed
Excluded: None Final Accrual: 254
Stratification Age: Tamoxifen:
Factors: SERMS: Aromatase inhibitors:
Duration of hot flashes: Frequency of hot flashes per day:
Schema: Randomization
Citalopram
Placebo
Treating Schedule:
Arm Agent Dose Route Days Freq
* Celexa (55 10 mg capsule Oral Daily Weeks 2-7
patients)/Placebo
(19 patients)
+ Celexa (55 10 mg capsule Oral Daily Week 2
patients)/Placebo
(18 patients)
+ Celexa/Placebo 20 mg capsule Oral Daily Weeks 3-7
# Celexa (55 10 mg capsule Oral Daily Week 2
patients)/Placebo
(18 patients)
# Celexa/Placebo 20 mg capsule Oral Daily Week 3
# Celexa/Placebo 30 mg capsule Oral Daily Weeks 4-7
CONTROL NCCTG CONTROL Committee N05C9 - Page 1 of 3
NCCTG Status Report for Study N05C9 - September 2007
* Citalopram 10 mg, 1 active capsule per day (55 patients)
* Placebo, 1 identical capsule per day (19 patients)
+ Citalopram 20 mg, titrating up to include 2 active capsules per day
(55 patienits)
+ Placebo, titrating up to 2 identical capsules per day (18 patients)
# Citalopram 30 mg titrating up to 3 active capsules per day (55
patients)
# Placebo titrating up to 3 identical capsules a day (18 patients)
Study Design: This is a 6 arm phase III randomized, double-blind, placebo-controlled evalua-
tion of citalopram for the treatment of hot flashes. The primary goal is to evaluate the efficacy of
three different doses of citalopram on hot flash scores in women with a history of breast cancer
or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
There are 3 treatment and 3 placebo arms for direct comparison.
Accrual: The study was closed to accrual on 04/13/2007, with final accrual of 254 patients.
Patient Characteristics: See patient characteristics table.
Adverse Events: There have been no grade 4 or grade 5 adverse events. The was one grade 3
insomnia which was deemed probably related to study treatment.
Study Status: The study is closed and date entry is on going.
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Ann Arbor 144 103 144
Carle 11 9 11
Cedar Rapids 8 5 8
Columbus 3 2 3
Des Moines 2 0 2
Duluth 10 9 10
Georgia CCOP 11 11 11
Jacksonville 1 1 1
Mayo 8 4 8
Mo Valley 2 2 2
Montana 1 1 1
N Indiana 8 8 8
Peoria 1 1 1
Sioux City 3 3 3
CONTROL NCCTG CONTROL Committee N05C9 - Page 2 of 3
NCCTG Status Report for Study N05C9 - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Toledo 4 4 4
Upstate Carol 19 19 19
Wichita 18 11 18
Total Membership Accrual 254 193 254
Baseline Characteristics Table:
Arm Arm Arm Arm Arm Arm
Characteristics
A B C D E F
Age Group
18 - 49 11 5 11 5 12 5
>=50 46 23 46 22 45 23
BREAST CANCER HISTORY
Yes 20 10 21 9 20 7
No 37 18 36 18 37 21
Current Aromatase Inhibitor
Yes 10 5 9 4 9 4
No 47 23 48 23 48 24
Current Raloxifene
Yes 2 1 2 0 2 1
No 55 27 55 27 55 27
Hot Flashes Duration
= 9 47 23 48 23 47 24
Time since Menopause (years)
1 10 5 10 1 10 4
2 14 2 5 3 7 3
3 3 1 8 0 5 1
>3 28 19 33 23 33 17
Unknown 2 1 1 0 2 3
No. of Hot Flashes Per Day
2-3 8 4 7 4 8 3
4-9 28 13 28 14 27 13
10 + 21 11 22 9 22 12
Race
White 51 24 50 26 49 25
Black or African American 5 3 7 1 8 3
Asian 1 0 0 0 0 0
Not reported: patient refused or not ava 0 1 0 0 0 0
Tamoxifen
Yes 6 2 5 1 4 2
No 51 26 52 26 53 26
CONTROL NCCTG CONTROL Committee N05C9 - Page 3 of 3
NCCTG Status Report for Other Closed CONTROL Trials - September 2007
969251 * Chemoprevention Trial of Acitretin Versus Placebo in Patients at HighRisk
for Basal Cell Carcinoma or Squamous Cell Carcinoma
* Closed: 02/21/2003
* Final accrual, patient characteristics, and adverse event tables
appeared in the Spring 2004 NCCTG meeting book.
* Manuscript status: in progress.
989251 * Phase II Topical Immunomodulatory Therapy With Imiquimod for
theChemoprevention of Recurrent and High-Grade Cervical Intraepithelial
Neoplasia (CIN)
* Closed: 07/02/2004
* Final accrual, patient characteristics, and adverse event tables
appeared in the Fall 2005 NCCTG meeting book.
* Manuscript status: in progress.
N00C1 * Phase III Placebo-Controlled, Randomized, Double-Blind Comparison ofE-
tanercept(Enbrel) Versus Placebo for the Treatment of Cancer-Associated
Weight Loss and Anorexia
* Closed: 03/01/2005
* Final accrual, patient characteristics, and adverse event tables
appeared in the Spring 2005 NCCTG meeting book.
* An abstract was presented at ASCO in 2006. A manuscript is in
progress.
N00C3 * The Efficacy of Gabapentin in the Management of Chemotherapy-Induced-
Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-
Controlled, Crossover Trial
* Closed: 12/05/2003
* Final accrual, patient characteristics and toxicity tables appeared in
the Fall 2004 NCCTG Book.
* The data has been entered and analyzed.
* A manuscript is in progress. An abstract was presented at ASCO 2005.
N00C9 * The Use of Ginkgo Biloba for the Prevention of Chemotherapy- Relat-
edCognitive Dysfunction
* Closed: 10/27/2006
* Final accrual, patient characteristics, and adverse event tables
appeared in the Spring 2007 NCCTG meeting book
* Manuscript status: in progress.
N00CA * Phase III Double-Blind Study of Depot Octreotide Versus Placebo in thePre-
vention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
* Closed: 10/28/2005
CONTROL NCCTG CONTROL Committee Other Closed Trials - Page 1 of 4
NCCTG Status Report for Other Closed CONTROL Trials - September 2007
* Final accrual, patient characteristics and toxicity tables appeared in
the Fall 2006 NCCTG Book.
* The data has been entered and analyzed.
* An abstract was presented at ASCO 2005. A manuscript is in
preparation.
N01C3 * The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced-
Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-
Controlled Trial
* Closed: 03/11/2005
* Final patient characteristics table appeared in the 2005 Fall NCCTG
Meeting book.
* A final report was submitted to NCI.
* An abstract was presented at ASCO as a poster presentation in 2006. A
manuscript is in preparation.
N01C4 * Phase III Double-Blind, Placebo-Controlled Randomized Comparison ofZ-
inc Sulfate Versus Placebo for the Prevention of Altered Taste in Patients
with Head and Neck Cancer During Radiation
* Closed: 10/07/2005
* Final accrual, patient characteristics, and adverse event tables
appeared in the Fall 2006 NCCTG meeting book.
* A final report was submitted to NCI.
* An abstract was presented at ASTRO as a poster presentation in 2006. A
manuscript is in preparation.
N01C5 * The Use of Valeriana Officinalis (Valerian) in Improving Sleep inPatients
Who Are Undergoing Treatment for Cancer: A Phase III Randomized, Pla-
cebo-Controlled, Double-Blind Study
* Closed: 03/09/2007
* Final accrual, patient characteristics, and adverse event tables
appeared in the Spring 2007 NCCTG meeting book.
* Manuscript status: in progress
N01C8 * Osteoporosis Prevention in Prostate Cancer Patients Receiving AndrogenA-
blation Therapy: A Phase III Randomized, Placebo-Controlled, Double-
Blind Study
* Closed: 07/15/2005
* Final patient characteristics and adverse events tables appear in the
Spring 2007 book.
* Manuscript is in preparation.
CONTROL NCCTG CONTROL Committee Other Closed Trials - Page 2 of 4
NCCTG Status Report for Other Closed CONTROL Trials - September 2007
N01C9 * Docetaxel and Infliximab/Placebo in Non-Small Cell Lung Cancer
(NSCLC)Patients >= 65 Years of Age or in NSCLC Patients With Poor Per-
formanc Status: A Double-Blind, Randomized, Placebo-Controlled Trial to
Prevent and Treat Wasting, Anorexia, and Asthenia in Chemotherapy-Naive
and Previously-Treated
* Closed: 10/05/2005
* Final accrual, patient characteristics, and adverse event tables
appeared in the Fall 2006 NCCTG meeting book.
* Manuscript status: in progress.
N01CB * The Efficacy of Lidocaine Patch in the Management of PostsurgicalNeuro-
pathic Pain in Patients with Cancer: A Phase III Double-Blind, Crossover
Study
* Closed: 06/02/2006
* Final accrual, patient characteristics, and adverse event tables
appeared in the Fall 2006 NCCTG meeting book.
* Manuscript status: in progress.
N02C1 * A Phase III Randomized, Placebo-Controlled, Double-Blind Trial ofRisedr-
onate (Actonel) for Prevention of Bone Loss in Premenopausal Women
Undergoing Chemotherapy for Primary Breast Carcinoma
* Closed: 03/03/2006
* Final accrual, patient characteristics and adverse events tables
appeared in the Spring 2007 NCCTG Book.
* The data has been entered.
* The analysis is ongoing.
N02C3 * The Use of Low Dose Testosterone to Enhance Libido in Female Cancer-
Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind
Crossover Study
* Closed: 02/02/2005
* Final accrual data appeared in the Fall 2005 NCCTG Book.
* Final toxicity data appeared in the Spring 2006 NCCTG Book.
* A manuscript was published in the Journal of the National Cancer
Institute: Barton DL, Wender DB, Sloan JA, Dalton RJ, Balcueva EP,
Atherton PJ, Bernath Jr AM, DeKrey WL, Larson T, Bearden III JD,
Carpenter PC, Loprinzi CL. Randomized controlled trial to evaluate
transdermal testosterone in female cancer survivors with decreased libido;
North Central Cancer Treatment Group Protocol N02C3. JNCI 2007.
N03C5 * A Phase III Randomized Trial of Gabapentin Alone or in ConjunctionWith
an Antidepressant in the Management of Hot Flashes in Women Who have
Inadequate Control with an Antidepressant Alone
* Closed: 07/29/2005
* Final accrual, patient characteristics, and adverse event tables
appeared in the Fall 2006 NCCTG meeting book.
CONTROL NCCTG CONTROL Committee Other Closed Trials - Page 3 of 4
NCCTG Status Report for Other Closed CONTROL Trials - September 2007
* Maunscript published:
Loprinzi CL, Kugler JW, Barton DL, Dueck AC, Tschetter LK, Nelimark
RA, Balcueva EP, Burger KN, Novotny PJ, Carlson MD, Duane SF, Corso
SW, Johnson DB, Jaslowski AJ. A phase III randomized trial of
gabapentin alone or in conjunction with an antidepressant in the
management of hot flashes in women who have inadequate control with an
antidepressant alone; NCCTG N03C5. Journal of Clinical Oncology
25:308-312, 2007.
N03CA * The Use of American Ginseng (panax quinquefolius) to ImproveCancer-
Related Fatigue: A Randomized, Double Blind, Dose-Finding, Placebo-
Controlled Study
* Closed: 07/05/2006
* Final accrual data and toxicity data appeared in the NCCTG 2007 spring
book
* Abstract presented at the 2007 ASCO meetings appeared in the NCCTG
2007 spring book
* Manuscript status: in development
N03CC * A Randomized, Controlled, Open-Label Trial of Empiric Prophylactic
vsDelayed Use of Zoledronic Acid for Prevention of Bone Loss in Post-
menopausal Women with Breast Cancer Initiating Therapy with Letrozole
After Tamoxifen
* Closed: 03/31/2006
* Final accrual, patient charateristics, and adverse event tables
appeared in the Sping 2007 NCCTG meeting book.
* A manuscript is in preparation.
CONTROL NCCTG CONTROL Committee Other Closed Trials - Page 4 of 4
Protocol Concepts for CONTROL - September 2007
N03C9 Phase III Trial of Honey for the Treatment of Radiation- orCombination
Therapy-Induced Stomatitis
Purpose of 1) To determine by a comparative, prospective, randomized trial if honey can
Study: decrease the frequency, duration, and severity of mouth pain caused by radi-
ation therapy to the oral cavity compared to standard therapy (salt and
sodium bicarbonate washes).
2) To evaluate the toxicity attributable to honey in this setting.
Schema: Randomize
Honey during RT
Standard therapy of salt and sodium bicarbonate rinses during RT
*****************************************************************************
N05C7 Long Acting Methylphenidate (Concerta) for Cancer-Related Fatigue:
APhase III, Randomized Double-Blind Placebo Controlled Study
Purpose of - Primary Objective
Study: 1) To test the efficacy of long acting methylphenidate as a therapy for cancer-
related fatigue in a randomized, double-blind, placebo-controlled study.
- Secondary Objectives
1) To evaluate tolerability and adverse events associated with use of long act-
ing methylphenidate for cancer-related fatigue in a controlled clinical trial
setting.
2) To study the effect of long acting methylphenidate on quality of life (QOL)-
related variables (vitality, sleep quality, overall QOL, QOL domains, other
fatigue measures, and perceived treatment efficacy) in this patient popula-
tion.
Schema: Randomize
Methylphenidate
Placebo
*****************************************************************************
N06C4 Phase III Randomized Double-Blind Study of Mometasone Furoate versus-
Placebo in the Prevention of Radiation Dermatitis in Breast CancerPatients
Receiving Radiation Therapy
CONTROL NCCTG CONTROL Committee Protocol Concepts - Page 1 of 6
Protocol Concepts for CONTROL - September 2007
Purpose of - Primary Endpoint
Study: 1) To compare maximum grade of radiation dermatitis as measured by the
CTCAE v3.0 for the mometasone and placebo arms to determine whether
mometasone furoate is effective in decreasing the maximal severity of radia-
tion dermatitis in patients undergoing primary or adjuvant radiation.
- Secondary Endpoints
1) To compare incidence of severe (Grade 3+) radiation dermatitis as measured
by the CTCAE v3.0 for the mometasone and placebo arms.
2) To compare time to onset and duration of severe (Grade 3+) radiation der-
matitis as measured by the CTCAE v3.0 for the mometasone and placebo
arms.
3) To assess skin toxicity and quality of life per weekly questionnaires includ-
ing the Skindex-16, LASA items, and STAT.
4) To assess the adverse event profile of mometasone furoate by CTCAE v3.0
and by a weekly patient-completed Symptom Experience Diary.
5) To compare skin toxicity data collected via provider-completed CTCAE
assessments, patient-reported Skindex-16 assessments, and patient/provider-
reported STAT assessments.
Schema: Randomize
Mometasone Furoate
Placebo
*****************************************************************************
N06C5 Chocolate as a Cough Suppressant: A Phase III, Double-Blinded,Random-
ized Trial
Purpose of 1) To determine if dark chocolate suppresses cough to a greater extent than pla-
Study: cebo.
2) To explore if dark chocolate improves cough-associated quality of life
symptoms to a greater degree than placebo.
3) To summarize the side effect profile of dark chocolate in a group of patients
suffering from cough.
4) To explore what other medications patients are taking for their cough over
the one-month study period.
Schema: Randomize
Dark chocolate (theobromine content 250 mg/oz) BID
Dark chocolate (theobromine content 125 mg/oz) BID
Placebo
CONTROL NCCTG CONTROL Committee Protocol Concepts - Page 2 of 6
Protocol Concepts for CONTROL - September 2007
*****************************************************************************
N06C9 A Phase III Randomized, Placebo-Controlled, Double-Blind Trial ofDenos-
umab for Prevention of Bone Loss in Premenopausal WomenUndergoing
Chemotherapy for Primary Breast Carcinoma
Purpose of - Primary Goal
Study: 1) To evaluate the effectiveness of denosumab versus placebo in the prevention
of bone loss in the lumbar spine at one year from baseline in premenopausal
women undergoing adjuvant or neoadjuvant chemotherapy for primary
breast cancer.
- Secondary Goals
1) To evaluate the effectiveness of denosumab versus placebo with respect to
bone loss in the lumbar spine at 6 mo & two years and the hip at 6 mo, one
year, and two years.
2) To evaluate the incidence of osteopenia and osteoporosis in the denosumab
versus placebo groups at 6 mo, one year, and two years from baseline.
3) To evaluate tolerability and adverse events associated with use of denos-
umab in a controlled clinical trial setting.
4) To differentiate symptoms related to hormone deprivation versus direct che-
motherapy effects in premenopausal women receiving adjuvant treatment as
well as to measure the effects of chemotherapy on neuroendocrine function-
ing; specifically androgen levels related to ovarian stromal functioning and
adrenal functioning.
5) To look at the effect of denosumab on markers of bone turnover and the sub-
sequent development of osteopenia and osteoporosis.
Schema: Randomize
Calcium + Vitamin D + Denosumab
Calcium + Vitamin D + Placebo
*****************************************************************************
N06C6 A Phase III Randomized Trial of Cryoablation vs. Radiation for thePallia-
tion of Painful Bone Metastases
Purpose of - Overall goal of this study is to determine the relative efficacy of percutane-
Study: ous cryoablation as compared to external beam radiation therapy (RT) for
the palliation of painful metastases involving bone in patients with cancer.
1) To determine pain relief in cancer patients with painful metastatic disease
involving bone following treatment with cryoablation as compared to RT.
2) To compare the impact on quality of life following cryoablation or RT in
patients with painful metastatic disease as measured using the validated
Brief Pain Inventory (BPI).
CONTROL NCCTG CONTROL Committee Protocol Concepts - Page 3 of 6
Protocol Concepts for CONTROL - September 2007
3) To determine change in analgesic use following therapy.
4) To determine the frequency and severity of complications following treat-
ment of painful metastases involving bone with either cryoablation or RT.
Schema: Randomize
A) Cryo treatment
B) RT treatment
Treated with alternate treatment if insufficient efficacy
*****************************************************************************
N06CA The Use of Topical Baclofen, Amitriptyline HCl, and Ketamine (BAK) ina
PLO Gel vs. Placebo for the Treatment of Chemotherapy InducedPeriph-
eral Neuropathy: A Phase III Randomized Double-Blind PlaceboCon-
trolled Study
Purpose of - Primary Goal
Study: 1) To compare sensory neuropathy as measured by the sensory scale of the
EORTC QLQ-CIPN20 for the topical amitriptyline HCI/baclofen/ketamine
and placebo arms to determine whether topical amitriptyline HCI/ baclofen/
ketamine is effective in improving sensory neuropathy in patients with
CIPN.
- Secondary Goals
1) To compare motor and autonomic symptoms and functioning (EORTC
QLQ-CIPN20); mood states (POMS-B); pain (BPI); peripheral neuropathy
(Peripheral Neuropathy Question); of patients in the two treatment arms.
2) To assess the adverse event profile of topical amitriptyline HCI/baclofen/
ketamine by CTCAE v3.0 and by a weekly patient-completed Symptom
Experience Diary.
3) To explore whether topical amitriptyline HCI/baclofen/ketamine is absorbed
systematically.
Schema: Randomize
Amitriptyline HCI/Baclofen/Ketamine
Placebo
*****************************************************************************
CONTROL NCCTG CONTROL Committee Protocol Concepts - Page 4 of 6
Protocol Concepts for CONTROL - September 2007
N06CB Phase III Double-Blind, Placebo Controlled Study of Haloperidol,Diphe-
nylhydramine, & Lorazepam (HDL) for the Treatment of Chemotherapy-
Induced Nausea and Vomiting (CINV) Occurring Despite
ProphylacticAntiemetic Therapy Among Patients Receiving Highly or
ModeratelyEmetogenic Chemotherapy
Purpose of 1) To evaluate the effectiveness of topical haloperidol, diphenylhydramine and
Study: lorazepam (HDL) for rescue therapy of CINV occurring despite prophylac-
tic therapy in patients who receive highly or moderately emetogenic chemo-
therapy.
2) To determine the tolerability of HDL in this patient population.
Schema: Randomize
HDL
Placebo
*****************************************************************************
N07C1 A Phase III, Randomized, Double-Blind, Placebo-controlled Evaluationof
Pregabalin for Alleviating Hot Flashes
Purpose of 1) To evaluate the efficacy of two different doses of pregabalin on hot flash
Study: scores in women with a history of breast cancer or women who do not wish
to take estrogen therapy for fear of increased risk of breast cancer.
2) To evaluate the side effect profile of these different doses of pregabalin in
this study population.
3) To evaluate the effect of these different doses of pregabalin on the secondary
outcome of interference of activities from hot flashes.
Schema: Randomization
Pregabalin
Placebo
*****************************************************************************
N07C2 The Use of Wisconsin Ginseng (panax quinquefolius) to ImproveCancer-
Related Fatigue: A Randomized, Double-Blind, Placebo-ControlledPhase
III Study
Purpose of - Primary Objective
CONTROL NCCTG CONTROL Committee Protocol Concepts - Page 5 of 6
Protocol Concepts for CONTROL - September 2007
Study: 1) To evaluate, using a placebo-controlled design, the efficacy of 1,500 mg per
day of panax quinquefolius (Wisconsin ginseng) as therapy for cancer-
related fatigue as measured by the vitality subscale of the SF-36.
- Secondary Objective
1) To evaluate toxicities and tolerability associated with 1,500 mg per day
panax quinquefolius when used for cancer-related fatigue.
2) To examine stress as a mediating variable on the effects of Wisconsin gin-
seng on cancer-related fatigue.
3) To explore the impact of ginseng on secondary endpoints.
Schema: Randomize
Wisconsin ginseng
Placebo
CONTROL NCCTG CONTROL Committee Protocol Concepts - Page 6 of 6
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Patient-Reported Outcomes and Quality of Life Committee
Goals
Quality of Life (QOL) research in NCCTG was officially established in September 1999 and was
renamed as the Patient-reported Outcome and Quality of Life Committee (PROQOL Committee)
in 2007. The primary goal of the PROQOL group is to assess relevant QOL endpoints that have
tangible outcomes for cancer patients and clinical practice. We will continue to follow our three
guiding principles of facilitating the implementation of QOL in treatment trials as appropriate,
developing new methodology to increase the precision and efficiency of QOL assessment, and
carry out QOL-directed protocols where indicated to complement the treatment trial research
portfolio.
As a result of the successful NCI site visit in July 2006, the PROQOL Committee was approved
as a Discipline-oriented Scientific Committee with six years of funding. New research for the
next grant cycle will include four major foci: 1) Exploring the relationship between genetics and
QOL, 2) Improve the clinical trial patient experience, 3) Gather data on patient’s assessment of
their clinical trial experience to inform and improve clinical trial design, and 4) Continue our
work on estimating the clinical significance and the value-added of QOL assessments.
Protocols and Studies
Since 1995, we have had 188 studies with a QOL component using a variety of different tools,
93 of which are NCCTG. The Uniscale, LASA, SDS, and FACT/FACIT continue to be the most
commonly used QOL tools. We have 7 NCCTG studies in development with QOL components:
cancer control (5), breast (1), GU (1). Currently there are 21 studies with QOL components that
are open to accrual: cancer control (6), QOL (1), breast (1), CNS (3), gastrointestinal (4), GYN
(1), head/neck (1), lung (2), melanoma (1), and other (1). The Was It Worth It protocol (N0392)
which assesses patient satisfaction with participation in NCCTG trials opened last year. There
are 61 closed protocols: breast (4), CNS (3), GI (16), GU (2), GYN (1), hematology (1), lung (7),
mesothelioma (1), QOL (1), and cancer control (29). Twenty-seven of the studies and have
published manuscripts. Five have submitted manuscripts and four have manuscripts accepted
but not yet published. The remaining closed studies are in some stage of manuscript completion.
Collaborative Efforts in 2007
The QOL psycho-social research team, lead by Dr. Teresa Rummans, have presented results of
the results of their structured multidisciplinary intervention which improved QOL (protocol
MC997C) at three national/international meetings. Recent events in regard to this study: the
spiritual well-being manuscript has been accepted by Supportive Oncology, the social well-being
manuscript has been accepted for publication in the Journal of Psychosocial Oncology, and both
the impact of the physical therapy component of the intervention on fatigue and the impact of
Desire for Death and Desire for Suicide are being investigated. The second multidisciplinary
intervention study (MC0491) is open and has accrued 96 patients thus far. This study extends
the intervention by actively involving the caregivers.
The Patient Advocate Committee submitted an R01 grant in 2006 to develop a patient clinical
trials support network for NCCTG. The goal is to minimize the ardors of being treated with
experimental therapeutic agents. This can improve patient compliance and clinical outcome for
novel agents. The grant was reviewed in July and was revised and resubmitted in February 2007.
The patient advocate committee was also instrumental in creating a model for real-time QOL
assessment in oncology clinical practice. The approach is to provide QOL data in the same way
as other clinical data (i.e. laboratory data, vital signs, or pain scores) to clinicians. If the initial
pilot studies are successful, this real-time QOL assessment will be integrated into selected
NCCTG clinical sites.
Clinical liaisons continue to provide support and facilitate interaction have between the NCCTG
QOL committee and tumor group committees. The liaisons are: Yolada Garces (Lung), Axel
Grothey (Colorectal), Paul Brown (Neuro-Oncology), Michele Halyard (Breast), Susan
McClement (nursing), and Tait Shanafelt (Hematology). Memberships with questions or ideas
regarding tumor-specific QOL should feel free to contact these energetic colleagues. Dr.
Michele Halyard has also agreed to serve as co-chair of the PROQOL Committee.
Pending Grants. A joint grant application between the Mayo Clinic/NCCTG and the University
of Amsterdam/Karolinska Instutite to further our work into exploring the relationshiop between
genetics and QOL. A new grant has been developed and submitted for R21 funding which
proposes to study the effects of a unique behavioral training intervention to determine if its use
will lead to improved emotional state and QOL while also reducing biometric markers of stress.
Other Activities
The PROQOL retreat was held on February 9-11, 2007 in Chicago, IL to develop a plan to
address the research aims proposed in the NCCTG grant. Attendees included the liaisons,
statisticians and other clinical staff. Results included research goals and specific plans for
increased implementation of QOL in each tumor group. Minutes of this retreat are available by
request to Vicki Schmidt (schmidt.vicki@mayo.edu)
A new initiative for the PROQOL Committee, called ASCPRO (Assessing the Symptoms of
Cancer using Patient-Reported Outcomes) is part of an evolving reconsideration of patient-
reported outcomes in clinical trials. ASCPRO was formed in response to the issuance by the U.S.
Food & Drug Administration of its draft guidelines for “Patient Reported Outcome Measures:
Use in Medical Product Development to Support Labeling Claims” in February 2006. ASCPRO
is co-chaired by Dr. Jeff Sloan of the Mayo Clinic and Dr. Charles Cleeland of M.D. Anderson
Cancer Center.
In June of 2007 the PROQOL group presented a workshop, “Interpreting PRO Scores for
Individual Patients”, at ISOQOL in Budapest, Hungary. This workshop presented an overview
of different ways to interpret PRO scores in assessing individual patients. Efforts that have
attempted to use PROs in clinical practice were described in terms of the statistical methods used
and how results were interpreted.
Also in June of 2007, “Massage: What the Evidence Shows” was presented at ASCO as a part of
the Topics in Complementary and Alternative Medicine: Evidence-based information for the
practicing physicians symposium in Rochester, MN and “Researchers' Perspectives on Working
with Patient Advocates” was presented at the 5th Annual NCCTG Patient Advocate Symposium
in Rochester, Minnesota.
The group is currently working on another Complimentary and Alternative Medicine
presentation for CTSA in March of 2008 which will describe statistical issues as related to CAM
studies.
The September 2007 issue of Value in Health will contain the manuscripts resulting from the
FDA workshop. The manuscripts summarize the recommendations for operationalizing the FDA
guidance for assessing patient reported outcomes in clinical trials so that PRO’s can be
incorporated effectively and efficiently into clinical trials. This information was also presented
in the Opening remarks, FDA Guidance on Patient-Reported Outcomes: discussion,
dissemination, and operationalization at ISOQOL in Lisbon, Portugal in October 2006.
The manuscripts produced as the results of the third conference on assessing clinical significance
for QOL assessments, Quality of Life III: Translating the Science of QOL Assessment into
Clinical Practice, in Scottsdale, AZ on October 2-4, 2003 will appear in he Mayo Clinic
Proceedings in October 2007.
Further, we are writing manuscripts to discuss the impact on study results of various imputation
techniques, discuss the results of the Control Preference Scale (CPS) in regard to the patient
characteristics and discuss the results of the CPS in regard to different health care systems. We
are perfoming meta-analyses: N0691 A meta-analysis of QOL differences by race in patients on
NCCTG and Mayo trials and N0591 A pooled-analysis to assess the value aded of PRO’s in
cooperative group oncology clinical trials. The latter being in conjunction with SWOG and
RTOG.
The QOL web site, https://ncctg.mayo.edu/ncctg/group/qol.html, continues to be a
complimentary resource. This web site contains instruments, references, and meeting minutes.
Members are encouraged to visit the site for updates on particular studies or to gather resource
information on QOL measures, papers, and activities. A bibiliography, scoring keys and
validity/reliability paragraphs are also available. The website was recently updated to include a
search engine to make it easier to find forms. There are currently over 150 different QOL forms
in this forms bank.
Published Manuscripts (2007)
• Improving the quality of life of geriatric cancer patients with a structured multidisciplinary
intervention: a randomized controlled trial. Palliative and Supportive Care 2007; 5:107-14.
• Caregiver role stress; when families become providers. Cancer Control 2007; 14(2):183-9.
• The burden of fatigue and quality of life in myeloproliferative disorders (MPDs) - an
international internet-based survey of 1179 MPD patients. Cancer 2007 Jan 1; 109(1):68-76.
• Randomized comparison of a nicotine inhaler and bupropion for smoking cessation and
relapse prevention. Mayo Clin Proc 2007 Feb; 82(2):186-95.
• How Do Distress and Well-being Relate to Medical Student Empathy? A Multicenter Study.
J Gen Intern Med 2007 Feb; 22(2):177-83.
• A pooled analysis of quality of life measures and adverse events data in North Central
Cancer Treatment Group lung cancer clinical trials. Cancer 2007 Feb 15; 109(4):787-95.
• Symptom control trials: a 20-year experience. J Support Oncol 2007 Mar; 5(3):119-125.
• Patient assessment of bowel function during and after pelvic radiotherapy: results of a
prospective phase III North Central Cancer Treatment Group clinical trial. J Clin Oncol
2007 Apr 1; 25(10):1255-9.
• Improving the quality of life of geriatric cancer patients with a structured multidisciplinary
intervention: a randomized controlled trial. Palliat Support Care 2007 Jun; 5(2):107-14.
• A prospective study of the relationship between medical knowledge and professionalism
among internal medicine residents. Acad Med 2007 Jun; 82(6):587-92.
• Priorities in colorectal cancer research: recommendations from the Gastrointestinal Scientific
Leadership Council of the Coalition of Cancer Cooperative Groups. J Clin Oncol 2007 Jun
1; 25(16):2313-21.
• Correlates of frailty in patients with coronary heart disease undergoing percutaneous
coronary interventions. Circulation 2007 May; 115(21):E556.
• Common troublesome symptoms and their impact on health-related quality of life (QoL) in
359 patients with myelodysplastic syndromes (MDS): results of an internet-based survey.
Leuk Res 2007 May; 31(Suppl 1):S106.
• Sloan et al. (in press) The Mayo Clinic Manuscript Series Relative to the Discussion,
Dissemination, and Operationalization of the Food and Drug Administration Guidance on
Patient-Reported Outcomes (Introduction to the manuscript series). Mayo Clinic
Proceedings, October 2007.
• Dueck et al. (in press) Editorial: Meeting on the FDA Draft Guidance on Patient Reported
Outcomes. Mayo Clinic Proceedings, October 2007.
• Rothman et al. (in press) Patient Reported Outcomes: Conceptual Issues. Mayo Clinic
Proceedings, October 2007.
• Snyder et al. (in press) Patient-Reported Outcome Instrument Selection: Designing a
Measurement Strategy. Mayo Clinic Proceedings, October 2007.
• Turner et al. (in press) Patient Reported Outcomes: Instrument Development and Selection
Issues. Mayo Clinic Proceedings, October 2007.
• Frost et al. (in press) What is Sufficient Evidence for the Reliability and Validity of Patient-
Reported Outcome Measures? Mayo Clinic Proceedings, October 2007.
• Sloan et al (in press) Analysis, Interpretation, and Reporting of Results of Clinical Studies
Based on Patient-Reported Outcomes. Mayo Clinic Proceedings, October 2007.
• Patrick et al. (in press) Patient-Reported Outcomes to Support Medical Product Labeling
Claims: FDA Perspective. Mayo Clinic Proceedings, October 2007.
• Osoba et al. (in press) Evaluating Health-Related Quality of Life in Cancer Clinical Trials:
The National Cancer Institute of Canada Clinical Trials Group Experience. Mayo Clinic
Proceedings, October 2007.
• Chauhan C. (in press) Denoument: L A Patient-Reported Observation. Mayo Clinic
Proceedings, October 2007.
• Guyatt et al. (in press) An Exploration of the Value of Health-Related Quality of Life
Information from Clinical Research and in Clinical Practice? Value Health, 2007.
• Hahn et al. (in pres) A Comparison of the Precision of Health-Related Quality of Life Data
Relative to Other Clinical Measures. Value Health, 2007
• Osoba et al. (in press) The Use of Quality of Life (QOL) Data to Support Medical Decision-
Making. Value Health, 2007.
• Sloan et al. (in press) Resources Required to Incorporate Quality of Life Assessments Into
Clinical Research. Value Health, 2007.
• Frost et al. (in press) Applying Quality of Life Data Formally and Systematically into
Clinical Practice. Value Health, 2007.
Oral and Poster Presentations (2006-2007)
2006 Impacting the quality of life in elderly cancer patients with a structured
multidisciplinary intervention: a randomized controlled trial
J Am Geriatric Soc 20067;54(4):S196
2006 Multi-dimensional prognostic factors for lung cancer
Am J Epidemiol 2006;163(11 Suppl):S24
Abstract 93
04/25/2006 Creating a unified approach to patient-reported outcomes research
panel discussion
Patient-Reported Outcomes Research Meeting, Washington, District of
Columbia
04/25/2006 New FDA Draft Guidance Document Review and Dissemination on Patient-
Reported Outcomes, recap of FDA/Mayo meeting
workshop
Patient-Reported Outcomes Research Meeting, Washington, District of
Columbia
05/18/2006 Assessing clinical significance for quality of life measures
University of Texas, Dallas, Texas
06/2006 How much missing data is too much? a single study exploration
Abstract 6116, ASCO
06/2006 Transdermal testosterone in female cancer survivors with decreased libido
Abstract 8507, ASCO
06/2006 What role do cancer patients want to play in treatment decision making: a
pooled-analysis
Abstract 8521, ASCO, Atlanta, Georgia
06/2006 Body mass index (BMI) and physical activity in long-term lymphoma
survivors: a pilot study
Abstract 17511, ASCO, Atlanta, Georgia
06/2006 The relationship between cancer patient treatment decision-making roles and
quality of life (QOL)
Abstract 6075, ASCO, Atlanta, Georgia
06/2006 What is the value added of patient-reported outcomes relative to physician-
rated symptom assessments
Abstract 8580, ASCO, Atlanta, Georgia
06/2006 A population-based study on the quality of life for cancer patients as reported
in a tumor registry follow-up
Abstract 8594, ASCO, Atlanta, Georgia
06/2006 Providing end-of-life care to patients seeking hope for cure: improving Mayo
Clinic palliative care utilization
Abstract 18552, ASCO, Atlanta, Georgia
06/2006 Statistical analysis of patient-reported outcome data
ASCO, Atlanta, Georgia
06/2006 Central nervous system tumors: correlates of clinical outcomes
ASCO, Atlanta, Georgia
06/29/2006 Statistical analysis issues for PROs: missing data, multiplicity, and
longitudinal data structure
ISOQOL Patient-reported Outcomes and FDA Guidance Meeting
Washington, District of Columbia
07/21/2006 Patient-Reported Outcomes and QOL issues in Lymphedema Clinical trials
GOG Annual Meeting, Washington, District of Columbia
09/05/2006 Overview of clinical trial design
Minority Investigator Career Development Workshop
Palm Desert, California
09/20/2006 PRO Assessment in cancer symptom management trials: the NCCTG
experience
PROACT meeting, Bethesda, Maryland
10/10/2006 What role do cancer patients want to play in treatment decision making: a
pooled analysis
ISOQOL, Lisbon, Portugal
10/10/2006 The relationship between cancer patient treatment decision-making roles and
quality of life
ISOQOL, Lisbon, Portugal
10/10/2006 Statistical analysis issues for PROs: missing data, multiplicity, and
longitudinal data structure
ISOQOL, Lisbon, Portugal
10/14/2006 Opening remarks, FDA Guidance on Patient-Reported Outcomes: discussion,
dissemination, and operationalization
ISOQOL, Lisbon, Portugal
10/20/2006 Monitoring strategies used with clinical trials
ONS Foundation Interdisciplinary Research Training Program
Washington, District of Columbia
01/18/2007 What do statisticians do? (Or at least what I do)
Clinical Research Program
Rochester, Minnesota
02/28/2007 Clinical trials and clinical significance for quality of life endpoints in
oncology.
University of Minnesota, Minneapolis, Minnesota
05/2007 Correlates of frailty in patients with coronary heart disease undergoing
percutaneous coronary interventions.
Omni Shoreham Hotel; 8th Scientific Forum on Quality of Care
Washington, District of Columbia
06/2007 Interpreting PRO Scores for Individual Patients
This workshop presented an overview of different ways to interpret PRO
scores in assessing individual patients. Efforts that have attempted to use
PROs in clinical practice were described in terms of the statistical methods
used and how results were interpreted.
ISOQOL, Budapest, Hungary
06/2007 Massage: What the Evidence Shows
Topics in Complementary and Alternative Medicine: Evidence-based
information for the practicing physicians
ASCO 2007, Chicago, Illinois
06/13/2007 Researchers' Perspectives on Working with Patient Advocates
5th Annual NCCTG Patient Advocate Symposium
Rochester, Minnesota
Members are encouraged to share feedback on the studies that follow this summary and
the research efforts initiated. Please contact Dr. Jeff Sloan, 507-284-9985 or email at
jsloan@mayo.edu for questions, input or feedback on the QOL research program.
Program Status Reports for QUALITY OF LIFE - September 2007
Protocol Concepts
N0054 A Prospective Longitudinal Study of Quality of Life FollowingRadio-
therapeutic Management of Localized Prostate Cancer
Multiple
N0392 Assessment of Patient Satisfaction with Participation in Phase II/IIINC-
CTG Clinical Trials
Other
N0591 A Pooled Analysis to Assess the Value Added of Patient-ReportedOut-
comes (PROs) in Cooperative Group Oncology Clinical Trials
N0691 A Meta Analysis of QOL Differences by Race in Patients on NCCTG
andMayo Trials
QOL NCCTG QOL Committee Table of Contents - Page 1 of 1
NCCTG Status Report for Study N0392 - September 2007
Assessment of Patient Satisfaction with Participation in Phase II/III NCCTG
Clinical Trials
Purpose of 1) The primary research hypothesis will be to examine whether patient quality
Study: of life (QOL) needs are being met throughout the course of the trial. Specif-
ically, determining if the patients thought participation in the clinical trial
was worthwhile.
Study Chairs: Jeff A. Sloan Ph.D. QC Specialist: Carol A. Leonard
Statistician: Pamela J. Atherton M.S. Nurse Resource:
Status: 06/07/2006 Activated Projected Number of Patients: 3870
Excluded: None Final Accrual: NA
Stratification None
Factors:
Schema: Register
CPS + WIWI assessment
Treating Schedule:
No treatment information
Study Design: Patients enrolled to designated NCCTG phase II or III treatment trials will be
asked to complete QOL assessments upon study enrollment, after the first cycle of treatment (or
1 month) and at the end of treatment (or 1 year). This will allow us to evaluate patient percep-
tions of their experience in NCCTG clinical trials.
Accrual: As of 8/6/2007, seven patients have been enrolled. There have been no cancels or
ineligibles.
Patient Characteristics: Patient characteristics are listed in the Baseline Characteristics Table.
Adverse Events: No adverse events are collected for this trial. Adverse events are being col-
lected for the parent trial(s).
Study Status: Study is continuing as per protocol.
QOL NCCTG QOL Committee N0392 - Page 1 of 2
NCCTG Status Report for Study N0392 - September 2007
Accrual Table:
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Des Moines 3 3 3
Duluth 1 1 1
Green Bay 1 1 1
Mayo 1 1 1
Scottsdale 1 1 1
Total Membership Accrual 7 7 7
Baseline Characteristics Table:
Arm
Characteristics
A
Age
65 3
Gender
Male 1
Female 6
Performance Score
0 3
1 4
Protocol Number
N0537 6
N0623 1
Race
White 7
Study Phase
II 7
QOL NCCTG QOL Committee N0392 - Page 2 of 2
NCCTG Status Report for Other Closed QOL Trials - September 2007
QOL NCCTG QOL Committee Other Closed Trials - Page 1 of 1
Protocol Concepts for QOL - September 2007
N0054 A Prospective Longitudinal Study of Quality of Life FollowingRadiothera-
peutic Management of Localized Prostate Cancer
Purpose of - Treatment
Study: 1) To determine the nature, intensity & time course of health-related quality of
life changes associated with external beam radiotherapy (EBRT), and with
prostate brachytherapy, in patients with early stage prostatic adenocarci-
noma. In addition, we will compare health-related quality of life indices &
changes over time between these treatments.
2) To determine the morbidity associated with EBRT or prostate brachyther-
apy, for this study group in relationship to health-related quality of life sta-
tus.
3) To determine the overall survival, disease-free survival, disease-specific sur-
vival, clinical patterns of tumor recurrence and time to biochemical failure
in this patient population.
Schema: Registration
External beam radiotherapy
Prostate brachytherapy
QOL NCCTG QOL Committee Protocol Concepts - Page 1 of 1
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Program Status Reports for NOVEL THERAPEUTICS - September 2007
Novel
N004E A Phase II Study of Gemcitabine (GEMZAR) and Irinotecan (CPT-11)
inPreviously Untreated Patients with Measurable Disease with
UnknownPrimary Carcinoma
N0071 Dose Finding Study of Aerosolized GM-CSF in the Treatment ofMeta-
static Melanoma in the Lung
N0189 Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA)
inNewly Diagnosed Mantle Cell Lymphoma (MCL)
N0377 Phase II Trial of RAD-001 in Metastatic Malignant Melanoma
N038H A Phase II Study of CCI-779 in Combination with Rituximab in
Patientswith Relapsed or Refractory Mantle Cell Lymphoma
N047A Phase II Trial of Carboplatin, Weekly Paclitaxel, and BiweeklyBevaci-
zumab in Patients with Unresectable Stage IV Melanoma
N0489 Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients
withPreviously Untreated Diffuse Large B-Cell Lymphoma
N048F A Phase II Trial of AZD2171 in Relapsed/Refractory B-Cell Chronic-
Lymphocytic Leukemia Patients
N057E A Phase II Trial of Carboplatin (CBDCA) and ABI-007 (ABX) in
Patientswith Unresectable Stage IV Melanoma
Protocol Concepts
N0682 A Phase II Clinical Trial of Denileukin Diftitox in Combination withRi-
tuximab in Previously Untreated Follicular B-cell Non-Hodgkin'sLym-
phoma
N0683 A Phase II Study of Sunitinib Malate for Treatment of Patients withRe-
lapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or SmallLym-
phocytic Lymphoma (SLL)
Other Closed Trials
NOVEL NCCTG NOVEL Committee Table of Contents - Page 1 of 2
Program Status Reports for NOVEL THERAPEUTICS - September 2007
N0087 Randomized Phase II Study of Interleukin-12 in Combination WithRi-
tuximab in Patients With Non-Hodgkin's Lymphoma
N0186 A Phase II Study of CCI-779 in Previously Treated Patients with Man-
tleCell Non-Hodgkin's Lymphoma
NOVEL NCCTG NOVEL Committee Table of Contents - Page 2 of 2
NCCTG Status Report for Study N004E - September 2007
A Phase II Study of Gemcitabine (GEMZAR) and Irinotecan (CPT-11) in Pre-
viously Untreated Patients with Measurable Disease with Unknown Primary
Carcinoma
Purpose of - Primary Goals
Study: 1) To evaluate the response rate of the combination of CPT-ll and Gemzar in
patients with Unknown Primary Carcinoma.
2) For Cohort I patients, to assess the adverse event profile and tolerability in
this patient population based upon the presence or absence of the UGT1A1
*28 polymorphism.
3) For Cohort II patients, to assess the adverse event profile and tolerability in
this patient population, based on the interval dose reductions and schedule
change.
- Secondary Goals
1) To assess time to progression (TTP) and overall survival (OS).
2) To perform immunohistochemical studies using CK7/20 to determine if cer-
tain patterns of staining are associated with response to therapy; we will also
store tissue blocks at Mayo Clinic for future translational studies.
3) To assess whether variation in multiple different genes whose protein prod-
ucts are involved in the uptake, metabolism, and distribution of Gemzar and
CPT-11 affect clinical outcomes (response, toxicity).
4) To determine whether cellular measurement of dFdCTP reflect the aggre-
gate consequences of cellular uptake, anabolism and catabolism of gemcit-
abine by measureing intracellular triphosphates in the mononuclear cells.
This pharmacologic or intervening phenotype will be used for correlation
with genotypes determined in this study.
Study Chairs: Matthew P. Goetz M.D. QC Specialist: Paula J. Stellmaker
Preston D. Steen M.D.
Statistician: Nathan R. Foster M.S. Nurse Resource: Wanda L. DeKrey R.N.,
OCN
Status: 02/20/2004 Activated Projected Number of Patients: 42
08/31/2007 Perm. Closed
Excluded: 5 Final Accrual: 31
Stratification None
Factors:
Schema: Register
UGT1A1 Genotyping + GEMZAR + CPT-11
Treating Schedule:
NOVEL NCCTG NOVEL Committee N004E - Page 1 of 6
NCCTG Status Report for Study N004E - September 2007
Arm Agent Dose Route Days Freq
A GEMZAR 1000 mg/m2 IV in 250/ml NS over 30 1,8,15,22 Retreat q 42 days (6 weeks -
(starting dose level minutes includes a 2-wk rest period)
for Cohort I)
A CPT-11 75 mg/m2 (starting IV in 500/ml D5W over 1,8,15,22 Retreat q 42 days (6 weeks -
dose level for 90 min, starting 30 min includes a 2-wk rest period)
Cohort I) after GEMZAR
B GEMZAR 750 mg/m2 (start- IV in 250/ml NS over 30 1, 8, 15 Retreat q 28 days includes a 1-wk
ing dose level for min rest period
Cohort II)
B CPT-11 75 mg/m2 (starting IV in 500/ml D5W over 1, 8, 15 Retreat q 28 days includes a 1-wk
dose level for 90 min starting 30 mins rest period
Cohort II) after GEMZAR
NOTE: As of Addendum 4, all new patients will be accrued to the Cohort
II (Arm B) dose levels listed above.
Study Design: This is a one-stage phase II study with an interim analysis and a lead-in phase to
assess tolerability. This study will assess the tolerability and confirmed response rate associated
with the treatment regimen of gemcitabine and irinotecan for patients with unknown primary
carcinoma.
Tolerability Phase (Cohort I): We'll accrue at least 6 patients to two different polymorphism
groups and assess the toxicity in these patients. This phase will allow us to determine the dose
level to use for the Cohort II patients for each polymorphism group.
The Cohort II study has been designed to look at the confirmed response rate in patients with
unknown primary carcinoma. Based upon the history of this disease we would expect at most
20% of patients to have a confirmed response. For this treatment combination to provide signif-
icant clinical improvement from standard therapy, the confirmed response rate should be at least
40%.
A Three-Outcome Phase II study design was developed to look at a maximum of 25 evaluable
patients (at the cohort II dose levels) to test the null hypothesis that the true confirmed response
rate in this patient population was at most 20%. This study design yielded a power of 83% to
detect a true confirmed response rate of 40%, with a significance level of 10%.
Interim Analysis: An interim analysis will be performed at the time the 13th patient becomes
evaluable for the appropriate Cohort II dose levels. If at least 3 confirmed responses are
observed in these initial 13 evaluable patients, we will continue enrollment to a maximum of 25
evaluable patients treated at the appropriate Cohort II dose levels. Otherwise, if 2 or fewer
patients have a confirmed tumor response, we will discontinue enrollment and conclude that the
regimen is not sufficiently active in this patient population.
NOVEL NCCTG NOVEL Committee N004E - Page 2 of 6
NCCTG Status Report for Study N004E - September 2007
Final Analysis: This regimen will be classified as not promising in this patient population if at
most 6 confirmed responses are observed in a total of 25 evaluable patients.
The results of this study will be classified as inconclusive if 7 confirmed responses are observed
in a total of 25 evaluable patients. In this case; other factors will play a role in determining
whether or not this regimen is considered promising and worthy of further study or not.
This regimen will be classified as promising if at least 8 confirmed responses are observed in all
25 evaluable patients. Subsequent larger studies may be recommended.
Accrual: As of the freeze date of August 6, 2007, 29 patients have been accrued. See accrual
table for further information.
Patient Characteristics: Of the 14 Cohort I patients (Arm A), 6 had a PS of 0 and 8 had a PS of
1. Of the 15 Cohort II patients (Arm B), 7 had a PS of 0 and 8 had a PS of 1. See the patient
characteristics table for further information by arm.
Available Information: 5 patients are ineligible at this time.
Adverse Events: Arm A Summary (Cohort I): 11 patients are evaluable for the Cohort I dose
levels. Of these, 10 (91%) patients experienced at least one grade 3+ adverse event and 5 (45%)
experienced at least one grade 4+ adverse event. In addition, 1 (9%) patient experienced a grade
5 Arrythmia (listed as Sudden Death), which was unrelated to the study medication. Finally, one
additional patient died of multi-organ failure, which was also unrelated to the study medication.
Due to all the serious adverse events in this study, it was decided to reduce the Gemzar dose to
750 mg/m2 for Cohort II patients in both genotype groups. In addition, it was decided to drop
the last day of the cycle (day 22), and change the cycle length to 4 weeks for the cohort II
patients. See the adverse event table for further information on these Arm A patients.
Arm B Summary (Cohort II): 11 patients are evaluable for adverse events. Of these 11 patients,
6 (55%) experienced at least one grade 3+ adverse event and 1 (9%) experienced a grade 4 Renal
Failure. None of these 11 patients experienced a grade 5 adverse event. See the adverse event
table for further information on these Arm B patients.
Study Status: The study permanently closed on August 31, 2007.
Accrual Table:
NOVEL NCCTG NOVEL Committee N004E - Page 3 of 6
NCCTG Status Report for Study N004E - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Carle 4 2 2
Cedar Rapids 1 0 1
Dayton 3 0 1
Des Moines 3 1 1
Duluth 2 0 0
MN CGOP 2 0 1
Mayo 5 1 2
Metro MN 3 0 1
Mo Valley 2 1 1
Scottsdale 1 0 0
Sioux City 1 0 0
Wichita 2 1 1
Total Membership Accrual 29 6 11
Baseline Characteristics Table:
Arm Arm
Characteristics
A B
Gender
f 6 6
m 8 9
Race
White 13 13
Black or African American 0 1
Asian 0 1
Not reported: patient refused or not ava 1 0
Tumor Grade Group
Missing 1 2
Low (grade 1 or 2) 3 3
High (grade 3 or 4) 10 10
UGT1A1 *28 Genotype
Positive for the UGT1A1 Polymorphism 6 10
Negative for the UGT1A1 Polymorphism 8 5
NOVEL NCCTG NOVEL Committee N004E - Page 4 of 6
NCCTG Status Report for Study N004E - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 11
Arm B Evaluable Patients: 11
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 4 36 3 27 1 9 0 0
B 3 27 3 27 0 0 0 0
LEUKOPENIA A 4 36 4 36 1 9 0 0
B 4 36 1 9 1 9 0 0
ANEMIA A 9 82 0 0 0 0 0 0
B 6 55 1 9 0 0 0 0
THROMBOCYTOPENIA A 4 36 2 18 0 0 0 0
B 2 18 2 18 0 0 0 0
Constitutional Symptoms FATIGUE A 3 27 2 18 0 0 0 0
B 3 27 0 0 0 0 0 0
WEIGHT LOSS A 2 18 0 0 0 0 0 0
B 2 18 0 0 0 0 0 0
Dermatology/Skin RASH A 5 45 0 0 0 0 0 0
B 0 0 0 0 0 0 0 0
Gastrointestinal ANOREXIA A 7 64 1 9 0 0 0 0
B 5 45 0 0 0 0 0 0
NAUSEA A 5 45 1 9 0 0 0 0
B 2 18 2 18 0 0 0 0
DEHYDRATION A 0 0 1 9 0 0 0 0
B 1 9 1 9 0 0 0 0
COLITIS A 0 0 0 0 1 9 0 0
B 0 0 0 0 0 0 0 0
VOMITING A 3 27 1 9 0 0 0 0
B 2 18 1 9 0 0 0 0
DIARRHEA-NO COLOSTOM A 6 55 1 9 0 0 0 0
B 5 45 1 9 0 0 0 0
Hepatic SGPT (ALT) A 0 0 0 0 0 0 0 0
B 1 9 1 9 0 0 0 0
BILIRUBIN A 0 0 0 0 1 9 0 0
B 0 0 1 9 0 0 0 0
Pain PAIN-ABDOMINAL A 0 0 0 0 0 0 0 0
B 2 18 1 9 0 0 0 0
Renal /Genitourinary RENAL FAILURE A 0 0 0 0 0 0 0 0
B 0 0 0 0 1 9 0 0
Death MULTI ORGAN FAILURE A 0 0 0 0 0 0 1 9
NOVEL NCCTG NOVEL Committee N004E - Page 5 of 6
NCCTG Status Report for Study N004E - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
B 0 0 0 0 0 0 0 0
SUDDEN DEATH A 0 0 0 0 0 0 1 9
B 0 0 0 0 0 0 0 0
Maximum Grade Adverse Event A 1 9 5 45 3 27 2 18
B 5 45 5 45 1 9 0 0
NOVEL NCCTG NOVEL Committee N004E - Page 6 of 6
NCCTG Status Report for Study N0071 - September 2007
Dose Finding Study of Aerosolized GM-CSF in the Treatment of Metastatic
Melanoma in the Lung
Purpose of -
Study: 1) To determine the immunomodulatory effects of the study regimen for
patients with metastatic melanoma.
2) To determine the toxicity profile of the study regimen for patients with met-
astatic melanoma.
3) To collect preliminary data regarding the therapeutic effects of the study
regimen for patients with metastatic melanoma.
-
Study Chairs: Svetomir Nenad Markovic M.D. QC Specialist: Butch K. Kvittem CCRP
Mohammad Amin Hussain M.D.
Statistician: Vera Suman Ph.D. Nurse Resource: Jill Healy R.N.
Status: 08/03/2007 Activated Projected Number of Patients: 85
Perm. Closed
Excluded: 5 Final Accrual: 40
Stratification None
Factors:
Schema: Register
GM-CSF Aerosol
Treating Schedule:
Arm Agent Dose Route Days Freq
GM-CSF Assigned at ran- Aerosol BID 1-7, 15-21 28 days
domization
NOVEL NCCTG NOVEL Committee N0071 - Page 1 of 3
NCCTG Status Report for Study N0071 - September 2007
Study Design: This is a dose escalation study to determine the immunostimulatory dose (ISD)
and toxicity associated with aerosolized GM-CSF in the treatment of patients with metastatic
melanoma to the lung. The doses to be tested are 500, 750, 1000, 1250, 1500, 1750, and 2000
mcg of GM-CSF bid days 1-7 and 15-21 with rest days 8-14 and 22-28. Each patient will
receive drug for two 28 day cycles. There will be no dose escalation within individual patients.
The dose escalation scheme is as follows: 5 patients will be accrued onto a dose level (starting at
500 mcg). If 2 or fewer achieve an ISD, 5 additional patients will be accrued to the next higher
dose level. If 3 or more patients achieve an ISD, 5 additional patients will be accrued to the
same dose level. If 6 or fewer (out of 10) achieve an ISD, 5 additional patients will be accrued at
the next higher dose level. If 7 or more achieve an ISD, then 10 patients will be treated at a dose
level halfway between this optimal ISD level and the next highest level previously examined.
Dose escalation will be terminated if at least 2/5 or 4/10 patients experience a dose limiting tox-
icity on a particular dose level.
Study Status: The results of this study were presented at the 2007 annual ASCO meeting. The
abstract from the poster presentation is given below:
Abstract No: 8565 Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Pro-
ceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 8565
Author(s): S. N. Markovic, V. J. Suman, P. Schaefer, R. Morton, K. M. Rowland
Abstract:
NOVEL NCCTG NOVEL Committee N0071 - Page 2 of 3
NCCTG Status Report for Study N0071 - September 2007
Background: Previous studies using low-dose (250 ug/dose) aerosolized sargramostim (granu-
locyte macrophage colony stimulating factor: aero-GM-CSF) for the treatment of metastatic
melanoma, revealed anecdotal clinical responses that appeared to correlate with an increase in
the number of tumor specific cytotoxic T lymphocytes (CTL) in blood. Herein, we address
whether or not further dose escalation of aero-GM-CSF is safe, results in greater increase of
melanoma specific CTLs, and affects clinical outcomes. Methods: A 5+5 dose escalation clinical
trial was conducted to determine the dose of aero-GM-CSF that would increase in the frequency
of peripheral blood melanoma specific CTLs in HLA-A2+ patients with metastatic melanoma to
the lungs. Aero-GM-CSF was administered twice daily on days 1-7 and 15-21 of a 28 day cycle
at doses of: 500, 750, 1,000, 1,250, 1,500, 1,750, and 2,000 ug per cohort. If at most 2 of 5
patients at a dose level reported a 5-fold increase in CTLs, dose escalation occurred. If not, 5
additional patients were treated at that dose. Dose escalation continued until =2 of 5 patients at a
dose level developed severe toxicity, at least 7 of the 10 patients at a dose level reported a 5-fold
increase in CTLs, or all dose levels were exhausted. Results: The study accrued 40 patients from
August 2002 to July 2006. Four patients cancelled participation prior to treatment. One patient
was replaced (500 ug) as he died within 13 days of registration. Among the 35 remaining
patients, median age was 58 (23-84), 72% were male, and 72% had a PS=0. Dose escalation was
not terminated due to toxicity. Toxicities = grade 3 (at least probably treatment related) included:
grade 3 fatigue (1) at 1,000 ug; and grade 3 cough (1), and grade 4 dyspnea (1) at 1,750 ug. At
the 2,000 ug dose, most patients (4 of 5) exhibited a greater than 2-fold increase in melanoma
specific CTLs. Two of these patients remain on treatment: one with partial response at 14.0
months and the other with stable disease at 6.5 months. A 5-fold increase in tumor specific CTLs
was not achieved in any patient. Conclusions: Aero-GM-CSF therapy administered at up to
2,000 ug/dose appears safe and seems to correlate with increased frequencies of tumor specific
CTLs in a dose-dependent fashion. Further dose escalation followed by clinical efficacy testing
is warranted.
Accrual Table:
Randomizing Total
Membership Entered
Carle 3
Cedar Rapids 1
Des Moines 2
Mayo 28
Metro MN 1
Mo Valley 1
Scottsdale 1
Sioux Falls 1
Toledo 2
Total Membership Accrual 40
NOVEL NCCTG NOVEL Committee N0071 - Page 3 of 3
NCCTG Status Report for Study N0189 - September 2007
Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly
Diagnosed Mantle Cell Lymphoma (MCL)
Purpose of 1) To determine if rituximab & 2-CDA will result in increased complete remis-
Study: sions compared to 2-CDA alone.
2) To determine if rituximab & 2-CDA will result in improved time to progres-
sion compared with historical results of 2-CDA alone.
3) To monitor for and summarize toxicities associated with rituximab + 2-CDA
therapy.
4) To characterize the effect of rituximab + 2-CDA on T-cell subsets, B-lym-
phocyte counts & immunoglobulin levels post therapy.
5) To describe patterns of gene expression in selected cases of MCL by
microarray analysis.
6) To assess tumor samples for chromosome abnormalities by interphase FISH
analysis.
Study Chairs: David J. Inwards M.D. QC Specialist: Patricia A. Koenig R.N.
Paul A. S. Fishkin M.D.
Statistician: David W. Hillman M.S. Nurse Resource: Kate Rodger R.N., B.S.N.,
M.S.H.C.M.
Status: 11/21/2003 Activated Projected Number of Patients: 31
09/23/2005 Perm. Closed
Excluded: 1 Final Accrual: 30
Stratification None
Factors:
Schema: Register
2-CDA + Rituximab
Treating Schedule:
Arm Agent Dose Route Days Freq
_ Rituximab 375 mg/m2 IV 1 Every 28 days
_ 2-CDA 5 mg/m2/d IV Days 4-8 Every 28 days
Study Status: An abstract was accepted at the 2006 ASCO meetings and the abstract was pre-
sented in Fall 2006 NCCTG Meeting Book. The manuscript has been submitted to JCO.
NOVEL NCCTG NOVEL Committee N0189 - Page 1 of 1
NCCTG Status Report for Study N0377 - September 2007
Phase II Trial of RAD-001 in Metastatic Malignant Melanoma
Purpose of - Primary Goal:
Study: 1) To estimate the median time to disease progression for patients diagnosed
with stage IV malignant melanoma treated with a weekly regimen of oral
RAD-001.
.
- Secondary Goals:
1) Evaluate median overall survival (OS) time.
2) To assess clinical benefit rates (i.e., stable disease, partial remission and
complete response rates).
3) To assess the toxicity profile of a weekly regimen of RAD-001 as a treat-
ment for patients with stage IV malignant melanoma.
4) Measure the effect of therapy using PET imaging (10 patients only).
5) Measure the effect of therapy on intensity of tissue VEGF and on microves-
sel density (10 patients only).
6) Measure the effect of therapy on serum VEGF levels (all patients).
7) Measure effect of therapy on the immune system (10 patients only).
8) To collect mRNA for future studies to measure changes in mRNA expres-
sion at a future date using gene chips (10 patients only).
Study Chairs: Ravi D. Rao M.D. QC Specialist: Butch K. Kvittem CCRP
Statistician: Jake B. Allred M.S. Nurse Resource: Evie Brennan R.N.,
B.S.N., O.C.N.
Status: 04/22/2005 Activated Projected Number of Patients: 73
03/02/2007 Perm. Closed
Excluded: None Final Accrual: 53
Stratification None
Factors:
Schema: Register
RAD-001
Treating Schedule:
Arm Agent Dose Route Days Freq
- RAD-001 10 mg PO Daily Daily*
*A cycle is considered to be 8 weeks in length.
NOVEL NCCTG NOVEL Committee N0377 - Page 1 of 5
NCCTG Status Report for Study N0377 - September 2007
Study Design: This trial utilizes a two-stage design to estimate the progression-free survival
rate at 16 weeks. The first stage of the trial will require 20 evaluable patients. If 6 or fewer are
progression free at 16 weeks, the trial will be stopped. Otherwise an additional 25 patients will
be accrued. If 18 or more (out of 45) are progression free at 16 weeks, then RAD-001 will be
considered a promising agent in this patient population and may be recommended for further
testing.
At the time of the interim analysis 24 patients were accrued. Of the first 20 patients 7 were pro-
gression free at 16 weeks. Although this rate allowed the trial to be re-opened, the study team
decided to restart the trial at a higher dose of RAD-001. This action was based on phase I data
indicating that RAD-001 could be given at 70 mg/week with no significant increase in side
effects.
The design described above was to be used exactly for the new cohort. Thus the maximum num-
ber of patients enrolled on this study will be 73 (i.e. 45 patients to evaluate efficacy at the higher
dose + 4 additional patients to account for ineligibility, cancellations or major violations + the
24 patients accrued at the lower dose).
Accrual: This study was temporarily closed on July 7, 2005 in order to complete the interim
analysis as per the study design. The accrual at the time of closure was 24 eligible patients.
Since the study was re-opened 07/28/2006 at a higher dose, 29 additional patients were accrued
making a total accrual of 53 eligible patients.
Due to results from the interim analysis at the higher dose, the trial was permanantly closed on
March 2, 2007.
Patient Characteristics: Of the 53 eligible patients accrued, 16 are white females and 37 are
white males. The number of metastatic sites reported range from 1 to 12, with 74% reporting 3
or fewer sites.
Adverse Events: At the lower dose, 2 patients (8%) reported grade 3+ adverse events. All of
them were unlikely related to study drug. One patient had grade 4 thrombosis and the other
patient had grade 4 encephalitis nos and grade 3 confusion, dysphasioa, hypokalemia,
hyponatremia, hypophosphatemia, and speech.
At the higher dose, there were no grade 4 events reported. Fifteen patients (52%) had at least 1
grade 3 event. Ten patients (34%) had a grade 3 event that was at least possibly related to the
study drug. The most common severe events that were at least possibly related to study drug
were fatigue and oral cavity (each with 3 patients - 10%), and anorexia, hyperglycemia, and sto-
matitis (each with 2 patients - 7%).
Accrual Table:
NOVEL NCCTG NOVEL Committee N0377 - Page 2 of 5
NCCTG Status Report for Study N0377 - September 2007
Randomizing Total Past 6 Past 12
Membership Entered Months Months
Bismarck 1 0 0
Carle 1 0 1
Fargo 3 0 3
Jacksonville 7 0 1
Lehigh 3 0 3
Mayo 29 0 11
Metro MN 5 0 5
Rapid City 1 0 1
Scottsdale 3 0 3
Total Membership Accrual 53 0 28
NOVEL NCCTG NOVEL Committee N0377 - Page 3 of 5
NCCTG Status Report for Study N0377 - September 2007
Baseline Characteristics Table:
Arm
Characteristics
A
Gender
f 16
m 37
Location of Metastatic Disease
M1a 7
M1b 10
M1c 36
Number Met Sites
1 11
2 13
3 16
4 4
5 5
6 2
7 1
12 1
Race
White 52
Black or African American 1
NOVEL NCCTG NOVEL Committee N0377 - Page 4 of 5
NCCTG Status Report for Study N0377 - September 2007
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 53
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 11 21 1 2 0 0 0 0
LEUKOPENIA A 16 30 1 2 0 0 0 0
ANEMIA A 4 8 2 4 0 0 0 0
THROMBOCYTOPENIA A 18 34 0 0 0 0 0 0
Cardiovascular THROMBOSIS A 0 0 0 0 1 2 0 0
Constitutional Symptoms FATIGUE A 37 70 3 6 0 0 0 0
Gastrointestinal ANOREXIA A 20 38 2 4 0 0 0 0
NAUSEA A 18 34 0 0 0 0 0 0
STOMATITIS A 13 25 2 4 0 0 0 0
VOMITING A 8 15 0 0 0 0 0 0
Oral cavity MS CE A 6 11 3 6 0 0 0 0
Infection/Febrile Neutropenia ENCEPHALITIS NOS A 0 0 0 0 1 2 0 0
Pain PAIN-HEADACHE A 13 25 0 0 0 0 0 0
Maximum Grade Adverse Event A 33 62 15 28 2 4 0 0
NOVEL NCCTG NOVEL Committee N0377 - Page 5 of 5
NCCTG Status Report for Study N038H - September 2007
A Phase II Study of CCI-779 in Combination with Rituximab in Patients with
Relapsed or Refractory Mantle Cell Lymphoma
Purpose of - Primary
Study: 1) To evaluate the overall response rate in previously treated MCL patients
when treated with CCI-779 plus rituximab.
2) To assess the tolerability and adverse events experienced in previously
treated MCL patients when treated with this combination of CCI-779 plus
rituximab for up to one year.
- Secondary
1) To assess the time-to-progression and overall survival of previously treated
MCL patients when treated with CCI-779 and rituximab.
2) To assess the time-to-response and duration of response in previously
treteated MCL patients when treated with CCI-779 and rituximab.
3) To determine if CCI-779 plus rituximab inhibits expression of members of
the PI3K signaling pathway.
- Translational
1) To learn the effects of CCI-779 and rutuximab on malignant mantle cells.
Study Chairs: Stephen Maxted Ansell M.D. QC Specialist: Patricia A. Koenig R.N.
Radha M. Rao M.D.
Statistician: Betsy LaPlant Nurse Resource: Mary B. Wilwerding R.N.
Status: 05/06/2005 Activated Projected Number of Patients: 73
Excluded: None Final Accrual: NA
Stratification None
Factors:
Schema: Register
CCI-779 + Rituximab
Treating Schedule:
Arm Agent Dose Route Days Freq
- CCI-779 25 mg (flat) IV over 30 minutes 1*, 8, 15, 22 Every 4 weeks
- Rituximab 375 mg/m2 IV 1, 8, 15, 22 Cycle 1 only
- Rituximab 375 mg/m2 IV Day 1 Cycles 3, 5, 7, 9, and 11
*The dose of rituximab given on Day 1 of Cycle 1 can be split into 2
days per investigator discretion for patients with large numbers of
circulating mantle cells in the blood (>=30,000 absolute lymphocyte
count). In those cases, the CCI-779 should be given on Day 1 with the
NOVEL NCCTG NOVEL Committee N038H - Page 1 of 4
NCCTG Status Report for Study N038H - September 2007
first dose of rituximab.
Study Design: A two-stage design and a one stage design with interim analysis will be applied
to patients with Rituximab sensitive (group 1) and Rituximab refractory (group 2) mantle cell
lymphoma, respectively.
Twenty-four rituximab sensitive patients will be enrolled in stage 1; if 8 or more responses are
observed an additional 17 rituximab sensitive patients will be enrolled. If 21 or more responses
(out of 41) are observed, then this regimen will be considered to have activity in this patient
population.
Twenty-five rituximab refractory patients will be enrolled in one stage. If 5 or more patients
respond to therapy then this regimen will be considered to have activity in this patient popula-
tion. An interim analysis will be performed after the first 16 group 2 patients have been accrued
and followed for 24 weeks. If none of the first 16 rituximab refractory patients respond, the reg-
imen will be considered inactive and accrual may be halted and the study results reported.
Accrual: This study was opened to the NCCTG May 6, 2005. Twenty-nine patients have been
accrued as of August 6, 2007. [Group 1 = 21, Group 2 = 15]
Patient Characteristics: See table.
Adverse Events: Three grade 4 thrombocytopenias and 1 grade 4 neutropenia have been
reported out of 34 patients with evaluable adverse event information. Common grade 3 adverse
events include thrombocytopenia (7 pts, 22%) fatigue (3 pts, 9%), leukopenia (3 pts, 9%), and
lymphopenia (3pts, 9%).
Study Status: The study is open to accrual.
NOVEL NCCTG NOVEL Committee N038H - Page 2 of 4
NCCTG Status Report for Study N038H - September 2007
Baseline Characteristics Table:
Arm
Characteristics
A
Gender
f 11
m 25
Group
Rituximab Sensitive 21
Rituximab Refractory 15
Number of Treatments
1 10
2 10
3 7
More than 3 9
Prior Stem Cell Transplant
Yes 9
No 27
Race
White 35
American Indian or Alaska Native 1
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 32
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 17 53 2 6 1 3 0 0
LEUKOPENIA A 18 56 3 9 0 0 0 0
ANEMIA A 20 63 1 3 0 0 0 0
LYMPHOPENIA A 2 6 3 9 0 0 0 0
THROMBOCYTOPENIA A 13 41 7 22 3 9 0 0
Constitutional Symptoms FATIGUE A 17 53 3 9 0 0 0 0
WEIGHT LOSS A 6 19 0 0 0 0 0 0
Dermatology/Skin NAIL CHANGES A 4 13 0 0 0 0 0 0
RASH A 16 50 1 3 0 0 0 0
Gastrointestinal ANOREXIA A 8 25 0 0 0 0 0 0
NAUSEA A 8 25 1 3 0 0 0 0
STOMATITIS A 5 16 0 0 0 0 0 0
CONSTIPATION A 6 19 0 0 0 0 0 0
TASTE A 4 13 0 0 0 0 0 0
DIARRHEA-NO COLOSTOM A 5 16 2 6 0 0 0 0
NOVEL NCCTG NOVEL Committee N038H - Page 3 of 4
NCCTG Status Report for Study N038H - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hemorrhage EPISTAXIS A 3 9 1 3 0 0 0 0
Lymphatics EDEMA: LIMB A 8 25 0 0 0 0 0 0
Metabolic/Laboratory HYPERCHOLESTEROLEMI A 21 66 1 3 0 0 0 0
HYPERTRIGLYCERIDEMIA A 19 59 2 6 0 0 0 0
HYPERGLYCEMIA A 16 50 0 0 0 0 0 0
ALK PHOSPHATASE A 6 19 0 0 0 0 0 0
Neurology NEURO-SENSORY A 6 19 0 0 0 0 0 0
Pulmonary COUGH A 4 13 0 0 0 0 0 0
PNEUMONITIS A 2 6 2 6 0 0 0 0
DYSPNEA A 4 13 0 0 0 0 0 0
Maximum Grade Adverse Event A 7 22 22 69 3 9 0 0
NOVEL NCCTG NOVEL Committee N038H - Page 4 of 4
NCCTG Status Report for Study N047A - September 2007
Phase II Trial of Carboplatin, Weekly Paclitaxel, and Biweekly Bevacizumab
in Patients with Unresectable Stage IV Melanoma
Purpose of - Primary Goal:
Study: 1) To assess the anti-tumor activity (progression free survival) and toxicity pro-
file of the study treatment in patients with unresectable stage IV melanoma.
.
- Secondary Goals:
1) Estimate the distribution of overall survival times.
2) Estimate the response rate as determined by the RECIST criteria.
3) Examine changes in blood levels of VEGF during the course of treatment.
4) Examine changes in immune homeostasis during the course of treatment.
Study Chairs: Svetomir Nenad Markovic M.D. QC Specialist: Carla R. Hilton
Daniel A. Nikcevich M.D.
Statistician: Vera Suman Ph.D. Nurse Resource: Evie Brennan R.N.,
B.S.N., O.C.N.
Status: 12/30/2005 Activated Projected Number of Patients: 47
11/03/2006 Perm. Closed
Excluded: None Final Accrual: 53
Stratification None
Factors:
Schema: Registration
CBDCA + Paclitaxel + Bevacizumab
Treating Schedule:
Arm Agent Dose Route Days Freq
Bevacizumab 10 mg/kg IV infusion over 90 min- 1 and 15 Every 28 days
utes
Taxol 80 mg/m2 250 mL D5W IV infusion 1, 8 , and 15 Every 28 days
over 1 hour
CBDCA Mg = target AUC IV over 30 minutes 1 Every 28 days
(6) x (CrCl + 25)
Study Design: A two-stage, phase II clinical trial design was chosen to examine the 8 week
progression-free survival and toxicity profile. The first stage of this trial will require 20 patients.
If 7 or fewer remain progression-free 8 weeks post registration, we will close the study to fur-
ther accrual and conclude that this regimen lacks sufficient activity to pursue in this patient pop-
ulation. If 7 or more eligible patients remain progression-free 8 weeks post registration we will
open to Stage II.
NOVEL NCCTG NOVEL Committee N047A - Page 1 of 3
NCCTG Status Report for Study N047A - September 2007
Stage II will require an additional 27 eligible patients. If a total of 20 or fewer remain progres-
sion-free 8 weeks post registration, we will conclude this regimen lacks sufficient activity to pur-
sue in this patient population. If 21 or more eligible patients remain progression-free at 8 weeks
without excessive toxicity, we may recommend further testing of this regimen in subsequent
studies in this population.
Accrual: A total of 53 patients have been enrolled. No patient has been declared ineligible or
cancelled participation prior to starting treatment.
Adverse Events: Adverse event data are available for 53 patients. Seventeen of these patients
received at least one cycle of treatment with growth factor support. THe most common severe
toxicities reported were hematologic. They were: leukopenia (83%-all grades; 40%-grade 3+);
neutropenia (87%-all grades; 53%-grade 3+); anemia (96%-all grades; 9%-grade 3+); and
thrombocytopenia (68%-all grades; 11%-grade 3+).
Study Status: This study was closed to enrollment having met its accrual goal. A manuscript of
the trial results is in preparation. The results of the first phase of this trial were presented at the
2007 annual ASCO meeting. Its abstract is presented below.
Abstract No: 8560 Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Pro-
ceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 8560, Author(s): D.G. Perez, V.
Suman, T. Amatruda, M. Gornet, R. Morton, S. Jilani, C. Constantinou, J. Egner, S. Markovic.
NOVEL NCCTG NOVEL Committee N047A - Page 2 of 3
NCCTG Status Report for Study N047A - September 2007
Abstract: BACKGROUND: In patients with metastatic melanoma, the combination of chemo-
therapy with an agent that specifically targets vascular endothelial growth factor (VEGF) might
be able to control tumor growth and progression much more effectively than chemotherapy
alone. METHODS: A two-stage phase II clinical trial was conducted in patients with unresect-
able stage IV melanoma to assess the anti-tumor activity and toxicity profile of the combination
of paclitaxel (80 mg/m2 IV on days 1, 8, and 15 of a 28-day cycle), carboplatin (AUC=6 IV on
day 1) and bevacizumab (10mg/kg IV on days 1 and 15). The primary endpoint of the study was
the 8-week progression-free survival rate (PFS). Enrollment to the second stage of the study
was opened if 8 or more of the first 20 patients enrolled remained progression-free at 8 weeks.
Eligible patients had measurable disease by RECIST criteria, a performance status (PS) of 0-2
and acceptable pre-registration organ function. Exclusion criteria included: brain metastases,
significant recent bleeding, uncontrolled hypertension and ongoing anticoagulation. The study
opened in February 2006 and completed full study accrual in August 2006. Data from the 20
patients enrolled in the first stage are presented here. RESULTS: Patients (60% male) had a
median age of 63 and had a good performance status (85% had PS of 0). M1c disease was
present in 45% of patients and 35% had undergone previous chemotherapy for stage IV mela-
noma (50% prior immunotherapy). Only 6 patients did not complete more than 2 cycles of che-
motherapy due to refusal (3), desire for alternative treatment (1) or progression (2). Median
follow-up among the 15 patients still alive was 5.5 months (range: 6 weeks - 9 months). The 8-
week PFS rate was 70% (14/20). The median time to progression was 163 days. One partial
response was observed. There were 3 disease-related deaths at 65, 120 and 190 days post-regis-
tration. The most common toxicities were neutropenia (95%; 45% = grade 3), anemia (95%;
15% = grade 3), fatigue (90%; 5% = grade 3), leukopenia (85%; 25% = grade 3), and thromb-
ocytopenia (75%; 5% = grade 3). Conclusions: The combination of paclitaxel, carboplatin, and
bevacizumab appears to be well tolerated and clinically active in patients with stage IV mela-
noma.
Accrual Table:
Randomizing Total
Membership Entered
Carle 3
Cedar Rapids 3
Dayton 4
Des Moines 5
Duluth 2
Jacksonville 1
Mayo 14
Metro MN 11
Mo Valley 1
Scottsdale 6
Sioux Falls 1
Wichita 2
Total Membership Accrual 53
NOVEL NCCTG NOVEL Committee N047A - Page 3 of 3
NCCTG Status Report for Study N0489 - September 2007
Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients with Pre-
viously Untreated Diffuse Large B-Cell Lymphoma
Purpose of - Primary goals
Study: 1) To prospectively assess the efficacy of combination of CHOP with epratu-
zumab and rituximab (ER-CHOP), as measured by 12-month, event-free
survival (EFS12), in patients with previously untreated stages II, III, and IV
diffuse large B-cell lymphoma.
2) To assess the use of PET scan routinely early in treatment and post-comple-
tion of chemotherapy and thereby assess the functional CR rate (CR/PR or
stable by CT scan and PET negative).
3) To assess the safety of ER-CHOP.
- Translational goal
1) To explore new laboratory prognostic factors for large cell lymphoma and
their relationship to clinical respone to ER-CHOP.
Study Chairs: Ivana N. Micallef M.D. QC Specialist: Patricia A. Koenig R.N.
Daniel A. Nikcevich M.D.
Statistician: 10103 Nurse Resource: Kate Rodger R.N., B.S.N.,
M.S.H.C.M.
Status: 01/20/2006 Activated Projected Number of Patients: 86
08/14/2007 Perm. Closed
Excluded: None Final Accrual: 107
Stratification None
Factors:
Schema: Register
Epratuzimab + Rituximab + CHOP Q 21 days (total of 6 cycles)
Treating Schedule:
Arm Agent Dose Route Days Freq
Epratuzumab 360 mg/m2 IV over 60 minutes 1 Every 21 days
Rituximab 375 mg/m2 IV over 4-8 hours 1 or days 1 and 2 Every 21 days
Cyclophospha- 750 mg/m2 IV 1 or 2 Every 21 days
mide
Doxorubicin 50 mg/m2 IV 1 or 2 Every 21 days
Vincristine 1.4 mg/m2 (max 2 IV 1 or 2 Every 21 days
mg)
Prednisone 100 mg/m2 po 5 days (days 1-5 or Every 21 days
2-6)
NOVEL NCCTG NOVEL Committee N0489 - Page 1 of 4
NCCTG Status Report for Study N0489 - September 2007
Treatment schedule - Use actual weight or estimated dry weight if
fluid retention. A cycle is 3 weeks (21 days).
Study Design: Study is a one stage, Phase II design.
Sixty-seven eligible and evaluable CD22+ patients will be accrued to this study. We expect to
accrue 86 total patients to this study in order to accrue the 67 evaluable patients while account-
ing for ineligible patients or patients who are not CD22+. If at least 46 successes are observed
out of the 67 total patients then this will be considered evidence of promissing activity in this
population. An interim analysis will be conducted on the first 34 evaluable patients. If there are
less than 20 successes in these 34 patients the regimen will be considered insufficiently active in
this population and study termination will be considered. If 20 to 25 successes are observed
then accrual will continue until 67 evaluable patients are enrolled. If more than 26 successes are
observed at the time of the interim analysis then this will be considered as evidence of promising
activity in this population. The results of the interim analysis may be reported and accrual may
continue to better determine the outcome of the secondary endpoints and the translational com-
ponent of the study.
Accrual: The study closed August 14, 2007 with a final accrual of 107. There have been 28
patients declared ineligible for either pathology or CD22 negative status.
Patient Characteristics: See table.
Adverse Events: When data was frozen for this report on August 6, 2007, adverse event infor-
mation was available on 73 patients. One grade 5 adverse event (disease progression) has been
reported, and it was not considered to be related to treatment. There have been 11 grade 4 non-
hematologic adverse events reported: 4 febrile neutropenia (3 definitely related to treatment; 1
possibly related), 3 thrombosis (2 possibly related to treatment; 1 not related), 1 dyspnea (defi-
nitely related), 1 pleural effusion (probably related), 1 stomach pain (possibly related), and 1
small intestine (not related). See table for listing of adverse events regardless of attribution.
Study Status: This study permanently closed on August 14, 2007 since the accrual objective
was met.
Baseline Characteristics Table:
NOVEL NCCTG NOVEL Committee N0489 - Page 2 of 4
NCCTG Status Report for Study N0489 - September 2007
Arm
Characteristics
A
Age Group
=60 57
B Symptoms Present
Yes 41
No 64
Gender
f 48
m 57
International Prognostic Index
0 4
LOW 19
LOW INTERMEDIATE 26
HIGH INTERMEDIATE 38
HIGH 14
5 4
LDH Elevated
Yes 70
No 35
Nodes Examined
0 28
1 34
>=2 43
Performance Score
0 43
1 50
2 8
3 4
Race
White 101
Black or African American 1
Asian 1
Unknown: Patient unsure 2
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 73
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 10 14 12 16 44 60 0 0
LEUKOPENIA A 12 16 12 16 41 56 0 0
NOVEL NCCTG NOVEL Committee N0489 - Page 3 of 4
NCCTG Status Report for Study N0489 - September 2007
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
ANEMIA A 12 16 7 10 0 0 0 0
THROMBOCYTOPENIA A 35 48 6 8 2 3 0 0
Cardiovascular THROMBOSIS A 0 0 2 3 3 4 0 0
Constitutional Symptoms FATIGUE A 20 27 4 5 0 0 0 0
Dermatology/Skin ALOPECIA A 31 42 0 0 0 0 0 0
Gastrointestinal NAUSEA A 7 10 2 3 0 0 0 0
VOMITING A 18 25 2 3 0 0 0 0
SM INTESTN OBSTRUCT A 0 0 0 0 1 1 0 0
Infection/Febrile Neutropenia FEBRILE NEUTROPENIA A 0 0 10 14 4 5 0 0
Metabolic/Laboratory HYPERGLYCEMIA A 5 7 5 7 0 0 0 0
Neurology NEURO-SENSORY A 31 42 0 0 0 0 0 0
Pain PAIN-STOMACH A 0 0 0 0 1 1 0 0
Pulmonary EFFUSION-PLEURAL A 1 1 0 0 1 1 0 0
DYSPNEA A 4 5 1 1 1 1 0 0
Syndromes CYTOKINE RELEASE SY A 9 12 2 3 0 0 0 0
Death DISEASE PROGRESSION A 0 0 0 0 0 0 1 1
Maximum Grade Adverse Event A 9 12 13 18 48 66 1 1
NOVEL NCCTG NOVEL Committee N0489 - Page 4 of 4
NCCTG Status Report for Study N048F - September 2007
A Phase II Trial of AZD2171 in Relapsed/Refractory B-Cell Chronic Lympho-
cytic Leukemia Patients
Purpose of - Clinical Objectives
Study: 1) To evaluate the response (CR, NPR, PR) rate of AZD2171 in patients with
previously treated chronic lymphocytic leukemia (CLL).
2) To evaluate the toxicity of treatment with AZD2171 in patients with previ-
ously treated CLL.
3) To evaluate in a secondary manner the complete response rate, progression-
free and overall survival distributions and duration of response in relapsed/
refractory CLL patient treated with AZD2171.
- Laboratory Objectives
1) Assess VEGFR-2 protein and phosphorylation levels in CLL B cells using
pre-treatment samples and evaluate the association with Rai stage at study
entry and clinical response to AZD2171.
2) Perform pre-clinical testing of AZD2171 in the induction of CLL B cell
apoptosis/cell death using pre-treatment samples, and evaluate the ability to
downregulate the phosphorylation status of VEGFR-2 of CLL B cells by
comparing in vitro samples with and without AZD2171.
3) Study the differences in in vitro levels of CLL-B cell apoptosis/cell death
and alteration of VEGFR-2 phosphorylation for pre-treatment samples with
and without AZD2171 and how these differences correlate with clinical out-
comes.
4) To assess if the clinical responses are associated with changes in bone mar-
row vascularity.
Study Chairs: Neil Elliot Kay M.D. QC Specialist: Patricia A. Koenig R.N.
Bipin R. Amin M.D.
Statistician: Betsy LaPlant Nurse Resource: Mary B. Wilwerding R.N.
Status: 05/12/2006 Activated Projected Number of Patients: 35
Excluded: 1 Final Accrual: NA
Stratification None
Factors:
Schema: Reg
AZD2171
Treating Schedule:
Arm Agent Dose Route Days Freq
AZD2171 45 mg Oral Daily Daily during 4 week cycle
NOVEL NCCTG NOVEL Committee N048F - Page 1 of 3
NCCTG Status Report for Study N048F - September 2007
Study Design: This is a two-stage trial with a primary endpoint of confirmed response.
Stage 1: Enter 16 evaluable patients on to the study. If at least 1 out of 16 evaluable patients is
observed to be a success then proceed to stage 2. Otherwise the regimen will be considered inef-
fective.
Stage 2: An additional 16 evaluable patients will be put on to the study. If 3 or fewer success are
observed in all 32 evaluable patients, the regimen will be considered to be ineffective. If 4 or
more successes are observed, then there will be sufficient evidence for further testing with this
treatment.
Accrual: This study opened on May 12, 2006, and accrued 15 patients so far.
Patient Characteristics: Of the 15 patients accrued, 6 patients have a clinical stage value of 1,
2 patients have a value of 3 and 7 patients have a value of 4. Additional descriptive factors are in
the table below.
Adverse Events: There has been 6 grade 4 adverse events in 4 patients, of which 4 are hemato-
logic, and all atleast possibly related to treatment. See the adverse events table for more details.
Study Status: This study opened as of May 12, 2006, and is temporarily closed to accrual as of
June 25, 2007 to assess the tolerability of this regimen in this patient population.
Baseline Characteristics Table:
Arm
Characteristics
A
Gender
f 4
m 11
Performance Score
0 9
1 4
2 2
Race
White 14
Black or African American 1
Grade 4/5 and Most Frequent Adverse Event Table:
NOVEL NCCTG NOVEL Committee N048F - Page 2 of 3
NCCTG Status Report for Study N048F - September 2007
Arm A Evaluable Patients: 14
Maximum Severity Per Patient
A
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M N % N % N % N %
Hematology NEUTROPENIA A 1 7 1 7 2 14 0 0
ANEMIA A 9 64 0 0 0 0 0 0
THROMBOCYTOPENIA A 8 57 3 21 2 14 0 0
Cardiovascular HYPERTENSION A 4 29 3 21 0 0 0 0
Constitutional Symptoms FATIGUE A 5 36 4 29 2 14 0 0
WEIGHT LOSS A 2 14 0 0 0 0 0 0
Endocrine HYPOTHYROIDISM A 2 14 1 7 0 0 0 0
Gastrointestinal ANOREXIA A 1 7 1 7 0 0 0 0
NAUSEA A 2 14 2 14 0 0 0 0
DIARRHEA-NO COLOSTOM A 9 64 2 14 0 0 0 0
Musculoskeletal MUSCLE WEAKNESS A 2 14 3 21 0 0 0 0
Pain PAIN-HEADACHE A 4 29 2 14 0 0 0 0
Pulmonary VOICE CHANGE A 5 36 1 7 0 0 0 0
DYSPNEA A 2 14 0 0 0 0 0 0
Renal /Genitourinary PROTEINURIA A 5 36 0 0 0 0 0 0
CREATININE A 2 14 0 0 0 0 0 0
Maximum Grade Adverse Event A 3 21 7 50 4 29 0 0
NOVEL NCCTG NOVEL Committee N048F - Page 3 of 3
NCCTG Status Report for Study N057E - September 2007
A Phase II Trial of Carboplatin (CBDCA) and ABI-007 (ABX) in Patients with
Unresectable Stage IV Melanoma
Purpose of - Primary Goals:
Study: 1) To assess the safety and anti-tumor activity of the combination of ABX and
CBDCA in the treatment of patients with unresectable stage IV melanoma
who have not received prior chemotherapy for their metastatic disease.
2) To assess the safety and anti-tumor activity of the combination of ABX and
CBDCA in the treatment of patients with unresectable stage IV melanoma
who have received prior chemotherapy for their metastatic disease.
- Secondary Goals:
1) Describe the impact of ABX and CBDCA chemotherapy on parameters of
immune function and angiogenesis for patients who have and have not been
previously treated with chemotherapy.
Study Chairs: Svetomir Nenad Markovic M.D. QC Specialist: Carla R. Hilton
Thomas Amatruda III M.D.
Statistician: Vera Suman Ph.D. Nurse Resource: Jill Healy R.N.
Status: 10/06/2006 Activated Projected Number of Patients: 74
Excluded: 1 Final Accrual: NA
Stratification
Factors:
Schema: Registration
ABI-007 + CBDCA
Treating Schedule:
Arm Agent Dose Route Days Freq
- ABI-007 100 mg/m2 IV over 30 minutes 1, 8, 15 Every 28 days up to 8 cycles
- CBDCA AUC 2 IV over 30 minutes fol- 1, 8, 15 Every 28 days up to 8 cycles
lowing ABI-007
Grouping factors: Prior chemotherapy for metastatic disease: Yes vs
No.
Study Design: For patients with malignant melanoma who have received prior chemotherapy
for their metastatic disease, a one stage phase II clinical trial was designed to assess whether the
tumor response rate with the combination of Abraxane and carboplatin is at least 20%.
NOVEL NCCTG NOVEL Committee N057E - Page 1 of 3
NCCTG Status Report for Study N057E - September 2007
For patients with malignant melanoma who have not received prior chemotherapy for their met-
astatic disease, a one stage phase II clinical trial was designed to assess whether the tumor
response rate with the combination of Abraxane and carboplation is at least 35%.
Each trial will enrolled 37 patients.
Accrual: Enrollment to the trial for patients with malignant melanoma who have not received
chemotherapy for their metastatic disease has closed, having met its accrual goal. One patient
was deemed a cancel since they did not receive study treatment.
Enrollment to the trial for patients with malignant melanoma who have received prior chemo-
therapy for their metastatic disease continues, with 22 eligible patients enrolled.
Adverse Events: Prior chemotherapy group - Adverse event data are available for 16 patients.
Severe (grade 3+) adverse events were reported in 9 (56%) atients. The most common severe
adverse event reported was neutropenia (38%).
No Prior Chemotherapy group - Adverse event data are available for all 27 evaluable patients.
Severe (grade 3+) adverse events were reported in 15 (56%) patients. The most common severe
adverse events reported were: neutropenia (30%), fatigue (7%), hyperglycemia (7%), and
neuro-sensory (7%).
See Adverse Events Table for all adverse events reported.
Accrual Table:
Randomizing Total
Membership Entered
Ann Arbor 2
Bismarck 1
Carle 3
Cedar Rapids 1
Dayton 2
Des Moines 3
Duluth 4
Fargo 2
Green Bay 4
Jacksonville 1
Lehigh 1
Mayo 13
Metro MN 3
Mo Valley 1
Montana 1
Oklahoma 1
Peoria 1
NOVEL NCCTG NOVEL Committee N057E - Page 2 of 3
NCCTG Status Report for Study N057E - September 2007
Randomizing Total
Membership Entered
Rapid City 2
Scottsdale 4
Sioux City 1
Sioux Falls 2
St. Cloud 3
Wichita 6
Total Membership Accrual 62
Grade 4/5 and Most Frequent Adverse Event Table:
Arm A Evaluable Patients: 43
A Maximum Severity Per Patient
Body Adverse
R Grade 1/2 Grade 3 Grade 4 Grade 5
System Event
M
N % N % N % N %
Hematology THROMBOCYTOPENIA A 17 40 1 2 0 0 0 0
ANEMIA A 33 77 0 0 1 2 0 0
LEUKOPENIA A 6 14 2 5 0 0 0 0
NEUTROPENIA A 16 37 11 26 3 7 0 0
Cardiovascular THROMBOSIS A 0 0 0 0 1 2 0 0
HYPOTENSION A 0 0 0 0 1 2 0 0
Constitutional Symptoms FATIGUE A 35 81 2 5 1 2 0 0
Dermatology/Skin ALOPECIA A 5 12 0 0 0 0 0 0
Gastrointestinal NAUSEA A 23 53 1 2 0 0 0 0
DIARRHEA-NO COLOSTOM A 3 7 0 0 1 2 0 0
VOMITING A 9 21 1 2 0 0 0 0
Infection/Febrile Neutropenia FEBRILE NEUTROPENIA A 0 0 0 0 1 2 0 0
CLOSTRIDIAL INFECTN A 0 0 0 0 1 2 0 0
Neurology NEURO-SENSORY A 15 35 2 5 0 0 0 0
Pain MYALGIA A 9 21 1 2 0 0 0 0
ARTHRALGIA A 10 23 0 0 0 0 0 0
PAIN-BUTTOCK A 0 0 0 0 1 2 0 0
Renal /Genitourinary URETERAL OBSTRUCTIO A 0 0 0 0 1 2 0 0
Maximum Grade Adverse Event A 19 44 18 42 6 14 0 0
NOVEL NCCTG NOVEL Committee N057E - Page 3 of 3
NCCTG Status Report for Other Closed NOVEL Trials - September 2007
N0087 * Randomized Phase II Study of Interleukin-12 in Combination WithRitux-
imab in Patients With Non-HodgkinsLymphoma'
* Closed: 10/08/2004
* Due to fact that IL-12 is no longer available, all patients have
discontinued treatment.
* The manuscript for this trial has been published: Clin Cancer Res
2006, 12(20 Pt 1):6056-6063.
N0186 * A Phase II Study of CCI-779 in Previously Treated Patients with MantleCell
Non-HodgkinsLymphoma'
* Closed: 09/02/2005
* The high dose cohort (250 mg) was reported in the Journal of Clinical
Oncology: Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R,
Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H,
Kaufmann SH. Phase II trial of single agent temsirolimus (CCI-779) for
relapsed mantle cell lymphoma. Journal of Clinical Oncology 2005;
23(23):5347-56.
* A manuscript on the low dose cohort (25 mg) is currently being
finalized.
NOVEL NCCTG NOVEL Committee Other Closed Trials - Page 1 of 1
Protocol Concepts for NOVEL - September 2007
N0682 A Phase II Clinical Trial of Denileukin Diftitox in Combination withRitux-
imab in Previously Untreated Follicular B-cell Non-Hodgkins'Lymphoma
Purpose of 1) To learn the response rate [complete response (CR), partial response (PR)]
Study: of Rituximab in combination with Denileukin diftitox in previously
untreated patients with advanced stage (3 or 4) CD20+ B-cell follicular
grade 1 and 2 non-Hodgkin lymphoma (NHL) who would otherwise be
observed.
2) To assess the overall survival, time-to-progression, duration of response, and
time-to-therapy of these patients after treatment with Rituximab in combina-
tion with Denileukin diftitox.
3) To determine whether treatment with Rituximab in combination with
Denileukin diftitox depletes or inhibits the function of Treg cells in patients
with untreated Follicular grade 1 and 2 B-cell NHL.
Schema: Reg
Rituximab
Denileukin
*****************************************************************************
N0683 A Phase II Study of Sunitinib Malate for Treatment of Patients withRe-
lapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or SmallLym-
phocytic Lymphoma (SLL)
Purpose of - Treatment
Study: 1) Assess the treatment response rate (CR, CCR, nPR, PR) of sunitinib in
patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL).
2) Assess the toxicity of sunitinib in patients with relapsed/refractory CLL/
SLL.
3) Assess other aspects of clinical efficacy such as duration of response, time to
progression, overall survival, and CR rate.
- Translational
1) Evaluate if known risk stratification parameters (i.e. immunoglobulin muta-
tional, ZAP-70, FISH defects and/or CD38 status) are related to clinical
response to sunitinib (mandatory).
2) Create a cell bank of patients participating in this trial for potential future
studies (optional).
Schema: Reg
Sunitinib
NOVEL NCCTG NOVEL Committee Protocol Concepts - Page 1 of 2
Protocol Concepts for NOVEL - September 2007
NOVEL NCCTG NOVEL Committee Protocol Concepts - Page 2 of 2
NCCTG Bibliography
Manuscripts (Published)
1982 Windschitl, Harold E. M.D.; Krook, James E. M.D.; Everson, Lloyd K. M.D.; Cullinan, Stephen A.
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advanced breast cancer and prior chemotherapy exposure Cancer Treat Rep 67:955-956, 1983
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1983
1984 Ingle, James N. M.D.; Ahmann, David L. M.D.; Gerstner, James B. M.D.; Greene, Stephanie J.;
O'Connell, Michael J. M.D.; Kvols, Larry K. M.D.: Evaluation of vinblastine administered by 5-
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1984
Krook, James E. M.D.; Fleming, T R; Eagan, Robert T. M.D.; Cullinan, Stephen A. M.D.; Pfeifle,
Delano M. M.D.; Elliott, Thomas E. M.D.; Etzell, Paul S. M.D.: A comparison of combination
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1985 Cullinan, Stephen A. M.D.; Moertel, Charles G. M.D.; Fleming, T R; Rubin, Joseph M.D.; Krook,
James E. M.D.; Everson, Lloyd K. M.D.; Windschitl, Harold E. M.D.; Twito, Donald I. M.D.; Mar-
schke, Robert F. Jr. M.D.; Foley, John F. M.D.; Pfeifle, Delano M. M.D.; Barlow, John F. M.D.: A
controlled comparison of fluorouracil plus adriamycin plus mitomycin C (FAM) versus fluo-
rouracil plus adriamycin versus fluorouracil alone in the management of advanced pancreatic
and gastric carcinoma JAMA 253:2061-2067, 1985
Krook, James E. M.D.; Ingle, James N. M.D.; Greene, Stephanie J.; Bowman, Warren D. M.D.;
Everson, Lloyd K. M.D.; Windschitl, Harold E. M.D.; Marschke, Robert F. Jr. M.D.; Laurie, John A.
M.D.; Cullinan, Stephen A. M.D.; Pfeifle, Delano M. M.D.; McCormack, Greg W. M.D.; Elliott,
Thomas E. M.D.: Randomized clinical trial of cyclophosphamide, 5-fluorouracil, prednisone
with or without tamoxifen in postmenopausal women with advanced breast cancer Cancer
Treat Rep 69:355-361, 1985
Krook, James E. M.D.; Jett, James R. M.D.; Fleming, T R; Dalton, Robert J. M.D.; Marschke, Robert
F. Jr. M.D.; Cullinan, Stephen A. M.D.; Windschitl, Harold E. M.D.; Everson, Lloyd K. M.D.;
Brunk, S F M.D.; Laurie, John A. M.D.; Foley, John F. M.D.; Larson, D: A controlled evaluation
of combined 5-fluorouracil, adriamycin, and mitomycin C (FAM) for the treatment of
advanced non-small cell lung cancer J Clin Oncol 3:842-848, 1985
Ingle, James N. M.D.; Greene, Stephanie J.; Brunk, S F M.D.; Krook, James E. M.D.; Everson,
Lloyd K. M.D.; Cullinan, Stephen A. M.D.; Pfeifle, Delano M. M.D.; Kvols, Larry K. M.D.; Reuter,
Nicholas F. M.D.; Laurie, John A. M.D.; Marschke, Robert F. Jr. M.D.; Ahmann, David L. M.D.:
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advanced breast cancer and prior chemotherapy exposure Am J Clin Oncol 8:275-282, 1985
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1986 Ingle, James N. M.D.; Krook, James E. M.D.; Greene, Stephanie J.; Kubista, Theodore P. M.D.;
Everson, Lloyd K. M.D.; Ahmann, David L. M.D.; Chang, M; Bisel, Harry F. M.D.; Windschitl,
Harold E. M.D.; Twito, Donald I. M.D.; Pfeifle, Delano M. M.D.: Randomized trial of bilateral
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Management 1:23-25, 1986
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70:1019-1020, 1986
Mailliard, James A. M.D.; Letendre, Louis M.D.; Dalton, Robert J. M.D.; Levitt, Ralph M.D.; Gerst-
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in the treatment of acute nonlymphocytic leukemia and blast crisis of chronic granulocytic leu-
kemia Med Pediatr Oncol 14:306-309, 1986
1987 Edmonson, John H. M.D.; McCormack, Greg W. M.D.; Krook, James E. M.D.; Long, Harry J. III
M.D.; Jefferies, John A. M.D.; Richardson, Ronald L. M.D.: Pilot study of cyclophosphamide
plus carboplatin in advanced ovarian carcinoma Cancer Treat Rep 71:199-200, 1987
Morton, Roscoe F. M.D.; Creagan, Edward T. M.D.; Veeder, Michael H. M.D.; Elson, David L.
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71:429-430, 1987
Morton, Roscoe F. M.D.; Creagan, Edward T. M.D.; Cullinan, Stephen A. M.D.; Mailliard, James A.
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nation N-phosphonacetyl-L-aspartate (PALA; NSC-224131) plus L-alanosine (NSC-153353)
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Lloyd K. M.D.; Jefferies, John A. M.D.; Mailliard, James A. M.D.: Randomized phase II studies
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M.D.; Wieand, H S Ph.D.: Clinical studies of biochemical modulation of 5-fluorouracil by leu-
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Ebbert, Larry P. M.D.; Malkasian, George D. M.D.; Abu-Ghazaleh, Samir M.D.; Podratz, Karl C.
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Dalton, Robert J. M.D.; Marschke, Robert F. Jr. M.D.; Veeder, Michael H. M.D.; Brunk, S F M.D.;
Mailliard, James A. M.D.; Twito, Donald I. M.D.; Earle, John D. M.D.; Anderson, Richard T. M.D.:
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Mailliard, James A. M.D.; Long, Harry J. III M.D.; McCormack, Greg W. M.D.: Evaluation of
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Philip J. M.D.; Campbell, Megan; Tschetter, Loren K. M.D.; Dakhil, Shaker R. M.D.; Mailliard,
James A. M.D.; Nikcevich, Daniel A. M.D.: Interleukin-1 Genetic Polymorphisms and Their
Relationship to the Cancer Anorexia/Weight Loss Syndrome in Metastatic Gastric and Gas-
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Haddock, Michael G. M.D.; Sloan, Jeff A. Ph.D.; Bollinger, John W. M.D.; Nikcevich, Daniel A.
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M.D.; Tenglin, Richard Charles M.D.; Schaefer, Paul L. M.D.; Dakhil, Shaker R. M.D.: Gemcitab-
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McWilliams, Robert R. M.D.; Goetz, Matthew P. M.D.; Morlan, Bruce W. M.S.; Salim, Muhammad
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Charles M.D.: Phase II Trial of Oxaliplatin, Irinotecan, 5-Fluorouracil, and Leucovorin for
Metastatic Colorectal Cancer, N0341 Clin Colorectal Cancer 6(7):516-521, 2007
Garces, Yolanda I. M.D.; Okuno, Scott H. M.D.; Schild, Steven E. M.D.; Mandrekar, Sumithra J.
Ph.D.; Bot, Brian B.S.; Martens, John M. M.D.; Wender, Donald B. M.D.; Soori, Gamini S. M.D.;
Moore, Dennis F. Jr. M.D.; Kozelsky, Timothy F. M.D.; Jett, James R. M.D.: Phase I NCCTG
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Goetz, Matthew P. M.D.; Knox, Stacey K.; Suman, Vera J. Ph.D.; Rae, James Ph.D.; Safgren,
Stephanie L.; Ames, Matthew M. M.D.; Visscher, Daniel W. M.D.; Reynolds, Carol; Couch, Fergus
J. Ph.D.; Lingle, Wilma L Ph.D.; Weinshilboum, Richard M. M.D.; Barr, Emily G.; Nibbe, Andrea
M. M.S.; Desta, Zeruesenay; Nguyen, Anne; Flockhart, David; Perez, Edith A. M.D.; Ingle, James
N. M.D.: The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant
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Dy, Grace K. M.D.; Krook, James E. M.D.; Green, Erin M. B.S.; Sargent, Daniel J. Ph.D.; Morton,
Roscoe F. M.D.; Fuchs, Charles S.; Ramanathan, Ramesh K.; Williamson, Stephen K. M.D.; Findlay,
Brain P. M.D.; Pockaj, Barbara A. M.D.; Sticca, Robert Peter M.D.; Alberts, Steven R. M.D.; Pitot,
Henry C. IV M.D.; Goldberg, Richard M. M.D.: Impact of Complete Response to Chemotherapy
on Overall Survival in Advanced Colorectal Cancer: Results from Intergroup N9741 J Clin
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Stephen K. M.D.; Findlay, Brain P. M.D.; Alberts, Steven R. M.D.; Pitot, Henry C. IV M.D.; Gold-
berg, Richard M. M.D.: Updated Efficacy and Toxicity Analysis of Irinotecan and Oxaliplatin
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M.D.; Vigliotti, Antonio P.G. M.D.; Marks, Randolph S. M.D.; Graham, David L. M.D.; Soori,
Gamini S. M.D.; Kugler, John W. M.D.; Tenglin, Richard Charles M.D.; Wender, Donald B. M.D.;
Adjei, Alex A. M.D.: A Results of a Pilot Study of High-Dose Thoracic Radiation Therapy with
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Hutchins, Laura F. M.D.; Livingston, Robert B. M.D.; Martino, Silvana D.O.: Sequenced Com-
pared With Simultaneous Anthracycline and Cyclophosphamide in High-Risk Stage I and II
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Halyard, Michele Y. M.D.; Jatoi, Aminah M.D.; Sloan, Jeff A. Ph.D.; Bearden, James D. III M.D.;
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W. M.D.; Zalduendo, Anthony C. M.D.; Stella, Philip J. M.D.; Loprinzi, Charles L. M.D.: Does
Zinc Sulfate Prevent Therapy-Induced Taste Alterations in Head and Neck Cancer Patients?
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gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in
women who have inadequate control with an antidepressant alone; NCCTG N03C5 J Clin
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Moore, Halle C.F. M.D.; Green, Stephanie J. Ph.D.; Gralow, Julie M.D.; Bearman, Scott I. M.D.;
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Flynn, Patrick J. M.D.; LaPlant, Betsy; Jaeckle, Kurt A. M.D.: The Relationship Between Six-
Month Progression-Free Survival and 12-Month Overall Survival End Points for Phase II Tri-
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Rusch, V W; Giroux, D J; Kraut, Michael J. M.D.; Crowley, J; Hazuka, M; Winton, T; Johnson,
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dara, David: Induction Chemoradiation and Surgical Resection for Superior Sulcus Non-
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Kaur, Judith S. M.D.; Roubidoux, M A; Sloan, Jeff A. Ph.D.: The importance of mammographic
screening for American Indian women The Indian Health Service Provider : , 0
Prados, M D; Scott, C; Sandler, H; Buckner, Jan C. M.D.; Phillips, T; Schultz, Charla; Urtasun, R;
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ston D. M.D.; Bernath, Jr., Albert M. M.D.: Phase III of Radiation Therapy Plus BCNU With or
Without Recombinant Interferon Alpha in the Treatment of Newly Diagnosed High-Grade
Gliomas Cancer : , 0
Loprinzi, Charles L. M.D.; Johnson, Patricia A. M.D.; Sloan, Jeff A. Ph.D.; Novotny, Paul J. M.S.;
Ellison, Neil M. M.D.: Have medical oncologists recently modified surveillance testing patterns
for melanoma and/or breast cancer survivors? Cancer Research : , 0
Martenson, James A. Jr. M.D.; Viglitotti, A G; Pitot, Henry C. IV M.D.; Geeraerts, Louis H. M.D.;
Sargent, Daniel J. Ph.D.; Haddock, Michael G. M.D.; Ghosh, Chirantan M.D.; Keppen, Michael D.
M.D.; Fitch, Thomas R. M.D.; Goldberg, Richard M. M.D.: A Phase I Study of Radiation Ther-
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Loprinzi, Charles L. M.D.: A Simple Approach for Defining Clinically Relevant Effects in Qual-
ity of Life Measures (or a Treatise Regarding Worms, Ducks, and Elephants) Medical Decision-
making : , 0
Sloan, Jeff A. Ph.D.: Statistical Issues in the Application of Cancer Outcome Measures (COM)
Research Book Chapter : , 0
Jatoi, Aminah M.D.; Hillman, Shauna L M.S.; Stella, Philip J. M.D.; Green, Erin; Adjei, Alex A.
M.D.; Nair, Suresh G. M.D.; Perez, Edith A. M.D.; Amin, Bipin R. M.D.; Schild, Steven E. M.D.;
Castillo, Rene A. M.D.; Jett, James R. M.D.: Should Elderly Non-Small Cell Lung Cancer
Patients Be Offered Elderly-Specific Trials? Results of a Pooled Analysis from the North Cen-
tral Cancer Treatment Group J Clin Oncol : , 0
Jatoi, Aminah M.D.; Hillman, Shauna L M.S.; Stella, Philip J. M.D.; Rowland, Kendrith M. M.D.;
Morton, Roscoe F. MD; Dakhil, Shaker R MD: Why Do Oncologists Prescribe -- or Not Pre-
scribe --Conventional Chemotherapy to Geriatric Patients with Metastatic Non-Small Cell
Lung Cancer? An Exploratory Study from the North Central Cancer Treatment Group Sup-
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Goldberg, Richard M. M.D.; Reuter, Nicholas F. M.D.; Mahoney, Michelle R. M.S.; Sargent, Daniel
J. Ph.D.; O'Connell, Michael J. M.D.; Rubin, Joseph M.D.; Hatfield, Alan K. M.D.; Krook, James E.
M.D.; Gesme, Dean H. M.D.; Kugler, John W. M.D.: 5-FU Based Chemotherapy for Colorectal
Cancer Patients Relapsing After Adjuvant Chemotherapy: A North Central Cancer Treat-
ment Group. Cancer Journal from Scientific American : , 2001
Marks, Randolph S. M.D.; Wiesenfeld, Martin M.D.; Sloan, Jeff A. Ph.D.; Hillman, Shauna L M.S.;
Tazelaar, Henry D. M.D.; Carroll, Thomas J. M.D.; Vukov, Allen M. M.D.; Krook, James E. M.D.;
Buckner, Jan C. M.D.; Marschke, Robert F. Jr. M.D.; Schaefer, Paul L. M.D.; Hatfield, Alan K. M.D.:
A Randomized Phase II Trial of TwoTopotecan-Based Combination Chemotherapy Regimens
in Advanced Stage Non-Small Cell Lung Carcinoma Lung Cancer : , 2002
Marks, Randolph S. M.D.; Nair, Suresh M.D.; Mahoney, Michelle R. M.S.; Allmer, Cristine; Sloan,
Jeff A. Ph.D.; Tazelaar, Henry D. M.D.; Drevyanko, Timothy F. M.D.; Michalak, John C. M.D.;
Veeder, Michael H. M.D.; Levitt, Ralph M.D.; Rowland, Kendrith M. Jr. M.D.: A Phase II Study of
Paclitaxel and Cisplatin for Extensive Stage Small Cell Lung Cancers Lung Cancer : , 2002
Goldberg, Richard M. M.D.; Sargent, Daniel J. Ph.D.; Morton, Roscoe F. M.D.; Mahoney, Michelle
R. M.S.; Krook, James E. M.D.; O'Connell, Michael J. M.D.: Sensing Toxicity and Adjusting
Ongoing Clinical Trials Protocols to Enhance Patient Safety: The History and Performance of
the NCCTG Real Time Toxicity Monitoring Program J Clin Oncol : , 2002
Hughes, Lorie L MD; Gray, Robert J. MD; Solin, Lawrence J MD; Robert, Nicholas J. M.D.; Mar-
tino, Silvana D.O.; Tripathy, Debu MD; Ingle, James N. M.D.; Wood, William C. MD: Efficacy of
Irradiation for Ovarian Ablation: Results of a Breast Intergroup Study Cancer : , 2003
Witizig, Thomas E MD; T, Silbertstein P MD; Loprinzi, Charles L; Sloan, Jeff; Novotny, Paul J;
Mailliard, James; Rowland, Kendrith; Levitt, Ralph; Morton, Roscoe: A Phase III Randomized
Double-Blind Study of Epoetin alfa Versus Placebo in Anemic Patients With Cancer Undergo-
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Markovic, Svetomir N M.D.; Suman, Vera J. Ph.D.; Dalton, Robert J. M.D.; Allred, Jake B. M.S.;
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parenchymal patterns with breast cancer risk factors and smoking in Alaska Native women
Cancer Epidemiology Biomarkers and Prevention : , 2004
Markovic, Svetomir N M.D.; Suman, Vera J. Ph.D.; Burch, Patrick A. M.D.; Jancewicz, Miroslav T.
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Ph.D.; Ebberts, Larry P. M.D.; Moore, Dennis F. Jr. M.D.; Mailliard, James A. M.D.: A Phase II
Study of Aerosolized GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma to the
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Fitch, Tom R. M.D.; Egner, James R. M.D.; Ebbert, Larry P. M.D.; Tschetter, Loren K. M.D.: A
Phase II Study of Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
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Amin, Bipin R. M.D.; Hillman, Shauna L M.S.; Nikcevich, Daniel A. M.D.; Dakhil, Shaker R. M.D.;
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Perez, Edith A. M.D.: Randomized Phase II Study of Docetaxel and Gemcitabine for Stage
IIIB/IV Non-Small Cell Lung Cancer: An NCCTG study Lung Cancer : , 2005
Okuno, Scott H. M.D.; Maples, William J. M.D.; Mahoney, Michelle R. M.S.; Fitch, Thomas R.
M.D.; Stewart, James A. M.D.; Fracasso, Paula M. M.D.; Kraut, Michael J. M.D.; Ettinger, David S.
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in Advanced Soft Tissue Sarcoma: A Phase II Study of the Phase II Consortiu J Clin Oncol
23:3069-73, 2005
Croghan, Ivana Ph.D.; Sloan, Jeff A. Ph.D.; Hurt, Richard D. M.D.; Croghan, Gary A M.D.; Dakhil,
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sation therapy Journal of the Society for Integrative Oncology : , 2005
Sloan, Jeff A. Ph.D.; Frost, Marlene H. Ph.D.; Halyard, Michele Y. M.D.; Dueck, Amylou: Apply-
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Introduction Current Problems in Cancer : , 2005
Sloan, Jeff A. Ph.D.; Frost, Marlene H. Ph.D.; Berzon, R; Dueck, Amylou; Guyatt, G; Moinpour, C
M; Sprangers, M; Ferrans, C E; Cella, D: The Clinical Significance of Quality of Life Assess-
ments in Oncology: A Summary for Clinicians Cancer : , 2005
Sloan, Jeff A. Ph.D.; Collign, R; Piderman, K: Quality of Life Spirituality and Mayo Franciscan
Values: A Research Perspective. Mayo Clin Proc : , 2005
Perez, Edith A. M.D.: Addressing the risk of late breast cancer recurrence: new data and rec-
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A. M.D.; Perez, Edith A. M.D.; Jett, James R. M.D.: Phase II Trial of Oral Topotecan and Intra-
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Tom R. M.D.; Novotny, Paul J. M.S.; Loprinzi, Charles L. M.D.: A Placebo-Controlled Double
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M.D.; Buckner, Jan C. M.D.: Validation of Single Item Linear Analog Scale Assessment (LASA)
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Miscellaneous (Letters to the Editor, Editorials, Other)
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Adjei, Alex A. M.D.: Functional polymorphisms in the human Folypolyglutamate Synthase
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Jaeckle, Kurt A. M.D.; Maurer, Matthew J.; Reid, Joel M. Ph.D.; Ames, Matthew M. M.D.; Giannini,
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Evanthia M.D.: Results of a Phase II Trial of Vorinostat in Patients With Recurrent Glioblas-
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Abstracts (Submitted)
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Lageman, S K; Cerhan, Jane H. Ph.D., Psi.; Brown, Paul D. M.D.; Anderson, S. Keith MS; Wu,
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Burnell, M; Levine, M; Chapman, J; Bramwell, V; Vandenberg, T; Chalchal, Haji I. M.D.; Albain,
Kathy M.D.; Perez, Edith A. M.D.; Rugo, Hope M.D.; Pritchard, Kathleen I M.D.: A Phase III
adjuvant trial of sequenced EC + filgrastim + epoetin alfa followed by paclitaxel versus
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Hobday, Timothy J. M.D.; Hillman, David W. M.S.; Aubry, Marie-Christine M.D.; Lingle, Wilma L
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tia, Alvaro M.D.; Perez, Edith A. M.D.: Translational correlates, including outcome for patients
with ER-/PR-/HER2 - (triple negative) disease from N0234, a phase II trial of gemcitabine and
erlotinib for patients with previously treated breast cancer ASCO : , 2007
Roy, Vivek M.D.; LaPlant, Betsy; Gross, Gerald Gerard M.D.; Palmieri, Frances M. R.N., M.S.N.;
Perez, Edith A. M.D.: NCCTG Phase II trial N0531 of weekly nab-paclitaxel in combination
with gemcitabine in patients with metastatic breast cancer ASCO : , 2007
Kutteh, Leila A. M.D.; Hobday, Timothy J. M.D.; LaPlant, Betsy; Hillman, David W. M.S.; Kauf-
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M.D.; Perez, Edith A. M.D.: A correlative study of cardiac biomarkers and left ventricular
ejection fraction from N9831, a phase III randomized trial of chemotherapy and trastuzumab
as adjuvant therapy for HER-2 positive breastcancer ASCO : , 2007
Perez, Edith A. M.D.; Romond, E H; Suman, Vera J. Ph.D.; Jeong, J; Davidson, Nancy E. M.D.;
Geyer, Charles E. Jr. M.D.; Martino, Silvana D.O.; Mamounas, E. P.; Kauffman, P A; Wolmark, Nor-
man M.D.: Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adju-
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Pockaj, Barbara A. M.D.: Impact of poor prognostic features on the surgical treatment of
breast cancer in a large cooperative group trial ASCO : , 2007
Slovak, M L; Bedell, V; Lew, D; Albain, Kathy M.D.; Ellis, G K; Livingston, Robert B. M.D.; Mar-
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Jatoi, Aminah M.D.; Rowland, Kendrith M. Jr. M.D.; Sloan, Jeff A. Ph.D.; Gross, Howard M. M.D.;
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Dakhil, Shaker R. M.D.; Loprinzi, Charles L. M.D.: Does Tetracycline prevent or palliate epider-
mal growth factor receptor (EGFR) inhibitor-induced skin rash? ASCO : , 2007
Meyers, M O; Hollis, D R; Mayer, Robert J. M.D.; Benson, III, Al B. M.D.; Goldberg, Richard M.
M.D.; Cummings, Bernard; Gunderson, Leonard L. M.D.; Martenson, James A. Jr. M.D.; Mac-
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Quevedo, F; Dakhil, Shaker R. M.D.; Gross, Howard M. M.D.; Merchan, Jaime R. M.D.; Roberts, L
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