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01

VIEWS: 18 PAGES: 35

									Louisiana State University Health Sciences Center
             Stanley S. Scott Cancer Center
                Minority- Based CCOP
                 Research Protocol List




                  Last Updated: 03/23/2011
                                                                                                              1
                                                      CLINICAL TRIALS CONTACTS
LSU-NEW ORLEANS                                                     Staff
Investigators                                                       Knox, Cindy…………………..225-2151342
Anthony, Lowell……………………………..504-464-8500                            Hebert, Stephen……………...225-215-1204
Lin, Tara………………………………………504-568-5151                                Bryant, Donna ………………..225-215-1348
Boulmay, Brian……………………………...504-568-5151                            Holmes, Donna
Fuselier, Harold (Urology) ………………...504-412-1620                    Kantner, Alyce…………………225-215-1206
Nurses                                                              Gibbons, Jennifer
Edwards, Cindy ……………………………..504-568-3430                            Thomassie, Amy
Nunez, Julie………………………………… 504-568-3435                              FAX …………………………….225-768-7601
Regulatory                                                          Regulatory
Johnson, Cara………………………………..504-568-3410                             Reyes, Maria …………………225-215-1249

ROBERT W. VEITH, LLC                                                ONCOLOGICS
Veith, Robert………………………………….504-455-0600                             Investigators
Nurse                                                               Deland, M. Maitland       337-706-8960
Nunez, Julie…………………………………...504-568-3435                            Harwood, Andrew R.        ”
                                                                    Krawczy, Julian J         “
MARY BIRD PERKINS – BATON ROUGE                                     Prellop, Perri B.         “
Investigators                                                       Wilt, Stephen R.          “
Bienvenu, Bryan .................. 225-767-1311
Billings, Frederic ................. 225-767-1311                   Nurse:
Hanson, David S. ................. 225-767-1311                     Cangelosi, Joi        (337) 237-2057
Patten, Judd ......................... 225-767-1311
Schmeeckle, Kelly…………..225-767-1311
Spell, Derrick ....................... 225-767-1311                 CANCER CARE SPECIALISTS
Fields, Robert S .................. 225-767-0847                    Investigators
Henkelmann, Greg ............... 225-767-0847                       Doria, Raul M.D.           985-857-8093
Johnson, Sheldon ............... 225-767-0847                       Gamble, Robert M.D.        985-857-8093
King, Maurice ....................... 225-767-0847                  McGaw, Harry               985-857-8093
Levine, Renee ...................... 225-767-0847
Lo, Kenneth.......................... 225-767-0847                  Nurse:
Sanders, Mary Ella…………..225-767-0847                                Toups, Ann                985-850-6300
Wood, Charles……………….225-767-0847
                                                                                                                                                     2

                                                                            BRAIN
CCCWFU                     Life expectancy of at least > 30 weeks.                                                                     MBPCC
91105: Phase III           Must have received a prior course of at least 30 Gy fractionated                                            CCS
Double Blind,               whole or partial brain irradiation for treatment of a primary brain   Arm A:                                Oncologics
Placebo Controlled          tumor or metastatic disease to the brain.                             Donepezil tablets x 24 weeks
Study of Donepezil in      Must have completed radiation > 6 months prior to enrollment          (Week 1-6: one 5 mg tablet per day)
Irradiated Brain            and have no radiographic evidence of brain disease, or stable         (Weeks 7-24: two 5 mg tablets per
                            brain disease defined as no evidence of tumor progression in the
                            3 months prior to enrollment.                                         Arm B:
                           Patients who have undergone one or more treatments with single        Placebo tablets x 24 weeks
                            fraction stereotactic radiosurgery (SRS) in addition to whole or      (Week 1-6: one tablet per day)
                            partial brain irradiation are eligible, as long as the SRS was        (Weeks 7-24: two tablets per day)
                            completed > 6 months prior to registration if NED or stable
                            disease.
                           Patients who have received PCI (prophylactic cranial irradiation)
                            are eligible.
                           Karnofsky Performance Status must be > 60 or ECOG 0-2.
                           Treatment with steroids, anti-cholinergics, anti-epileptics, anti-
                            depressants, and /or sedatives/benzodiazepines is acceptable,
                            but the patient must be on a stable or decreasing dose at the
                            time of study entry.
                           Patients using narcotic analgesics on a stable dose and/or prn
                            basis are eligible.
                           Patients currently on a stable dose of Methylphenidate or
                            Dextramphetamine are eligible.
                           For patients with brain metastases, if extracranial primary or
                            metastatic disease is present, it must have responded to local
                            and/or systemic treatment. Must be stable in the 3 months prior
                            to enrollment.
                           Patient must not have any planned therapy, including surgery,
                            brain radiation of any type, chemotherapy, or immunotherapy
                            during the next 30 weeks for brain or extracranial primary
                            metastatic disease.
                           Hormonal therapy for patients with breast or prostate cancer is
                            acceptable.
                           Breast patients receiving therapy with Herceptin are allowed.
                           Patients cannot be currently taking dementia drugs, cognitive
                            enhancers, neuroleptics, and/or anti-parkinsonian agents. For
                            patients who have used these drugs in the past, they must not
                            have used them in the 2 weeks prior to enrolling on the study.
1 rx credit
                                                                                                                                                                                    3
                                                                                  BRAIN
IRB #7591C: RTOG   · Patients must have histologically proven diagnosis of WHO grade IV glioblastoma or     Arm1 = RT + TMZ + placebo                                     MBPCC
0825 PHASE III     gliosarcoma confirmed by central review prior to step 2 registration. Patients must      Arm2 = RT + TMZ + bevacizumab                                 MCLNO-
DOUBLE-BLIND       have tumor tissue that is determined by central pathology review prior to step 2                                                                       pending
                   registration to be adequate for MGMT analysis and determination of molecular             Initiation of chemoradiation:
PLACEBO-
                   profile.                                                                                 Radiation 60 Gy in 2 Gy fractions over 6 weeks
CONTROLLED
                   · Patients’ tumor must have a supratentorial component.                                  concurrently with
TRIAL OF           · Patients must have recovered from surgery, postoperative infection, and other
CONVENTIONAL                                                                                                Temozolomide 75 mg/m2 PO QD during radiation
                   complications before step 2 registration.
CONCURRENT         · Patients must have a diagnostic contrast-enhanced MRI of the brain performed           course
CHEMORADIATION     preoperatively and postoperatively prior to initiation of radiotherapy; the
AND ADJUVANT       postoperative scan must be performed ≤ 28 days prior to step 1 registration.             After the first three weeks of chemoradiation, patients are
TEMOZOLOMIDE       · Patients must have an MRI or CT scan ≤ 10 days prior to the start of radiation
                                                                                                            randomized and begin placebo or bevacizumab while
PLUS               therapy, and it must not demonstrate significant postoperative hemorrhage (defined as
                   > 1 cm diameter of blood).                                                               continuing chemoradiation
BEVACIZUMAB
                   · Patients must document steroid doses ≤ 14 days prior to step 2 registration.           Beginning Week 4 of chemoradiation:
VERSUS
                   · Patients must have Karnofsky performance status ≥ 70.                                  Placebo or bevacizumab 10 mg/kg IV Days 1 and 15 of
CONVENTIONAL       · Patients must have systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 90
CONCURRENT                                                                                                  each 28-day cycle for 2 doses during chemoradiation
                   mg Hg within 14 days prior to step 2 registration.
CHEMORADIATION     · Patients who are on full-dose anticoagulation must not have any active bleeding or     and 1 additional dose 2 weeks after the completion of
AND ADJUVANT       pathological condition that carries a high-risk of bleeding and must have an in-range    chemoradiation.
TEMOZOLOMIDE       INR on a stable dose.
IN PATIENTS WITH   · Female patients must not be pregnant or lactating and all patients of childbearing
                                                                                                            Beginning 4 weeks after completion of chemo-
NEWLY              potential must practice adequate contraception.
                   · Patients must not have had prior invasive malignancy, except non-melanomatous          radiation:
DIAGNOSED
GLIOBLASTOMA       skin cancer, unless disease free for ≥ 3 years per Section 3.2.1.                        Temozolomide 150-200 mg/m2 PO Days 1-5 q 28 days
                   · Patients must not have recurrent or multifocal malignant gliomas.                      x 6-12 cycles concurrently with
                   · Patients must not have metastases detected below the tentorium or beyond the cranial
THERAPEUTIC
                   vault.                                                                                   Placebo or bevacizumab 10 mg/kg IV Days 1 and 15 q
CREDITS: 1.0                                                                                                28 days x 6-12 cycles
                   · Patients must not have had prior chemotherapy or radiosensitizers for cancers of the
CANCER CONTROL
                   head and neck region, nor any prior temozolomide or bevacizumab for any reason.
CREDITS: 0.5
                   · Patients must not have had prior use of Gliadel wafers or any other intratumoral or
                   intracavitary treatment.
                   · Patients must not have had prior radiotherapy to the head or neck (except for T1
                   glottic cancer) resulting in overlap of radiation fields.
                   · Patients must not have severe, active co-morbidity, as defined in Section 3.2.6.
                   · Patients must not be treated on any other therapeutic clinical protocols ≤ 30 days
                   prior to study entry or during participation in the study.
                                                                                                                                                                      4
                                                                               BRAIN
     TITLE                                        ElIGIBILITY                                                            TREATMENT                            LOCATION
                  Pre-registration Eligibility:                                                         Arm A (Radiation):                                    MBPCC
ECOG 3F05         · Patients must have pathological diagnosis of astrocytoma grade 2,                   Radiation* to 5040 cGy in 28 daily fractions of 180
                  oligodendroglioma grade 2, or oligoastrocytoma grade 2 (mixed glioma                                                                        CCS
Phase III Study                                                                                         cGy each, given M-F for 5 ½ weeks.
                  containing astrocytoma and oligodendroglioma). Patients must not have pilocytic
of Radiation      astrocytoma, ganglioglioma, pleomorphic xanthastrocytoma, or dysembryoplastic
Therapy with or   neuroepithelial tumors.                                                               Arm B (Radiation + Temozolomide):
without           · The tumors must be supratentorially located.                                        Radiation* to 5040 cGy in 28 daily fractions of 180
                  · Patients must be ≥ 18 years of age with Karnofsky PS ≥ 60%.
Temozolomide                                                                                            cGy each, given M-F for 5 ½ weeks.
                  · Patients must have paraffin-embedded tumor specimen available for submission
for Symptomatic   for confirmation of pathological diagnosis and determination of 1p/19q deletion
or Progressive    status.                                                                               Concurrently with
Low-Grade         · Patients must currently have at least one of the following a) uncontrolled          TMZ 75 mg/m2 QD during radiotherapy for
                  symptoms (i.e., HA associated with mass effect, uncontrolled seizures despite two     approximately 5 ½ weeks.
Gliomas           different antiepileptic drug regimens, focal neurological symptoms, cognitive
                  symptoms or deficits), b) tumor progression by serial MRIs (i.e., new or
                  progressive enhancement or new or progressive T2 or FLAIR signal abnormality),        Followed approximately 28 days later by
THERAPEUTIC
                  or c) age ≥ 40 years.                                                                 TMZ 150** mg/m2 Days 1-5 q 28 days
                  · Patients must be able to undergo MRI with and without contrast.
CREDITS: 1.0                                                                                            Give a total of 12 28-day cycles
CANCER CONTROL    · Patients must not have had previous radiation, cytotoxic chemotherapy,
CREDITS: 0.5      radiosurgery, or investigational treatment directed at the brain tumor at any time.
                  There is no limit on the number of previous surgical procedures on this tumor.        * Can be 3D conformal or IMRT.
                  · Patients must not have had previous RT to the head for any condition, unless the    ** If tolerated, dose can be increased to 200 mg/m2
                  ports for that radiation completely excluded the brain.                               beginning Cycle 2.
                  · Patients must not have any diagnosed malignancy (except for non-melanoma
                  skin cancer or cervical cancer in situ) unless they have been disease-free for ≥ 5
                  years.
                  · Patients must not have medical conditions that increase the risk of radiation or
                  TMZ chemotherapy. No uncontrolled infection, no known positivity for HIV, no
                  other disorder limiting expected survival to < 5 years.
                  · Patients may have undergone gross total resection and have no detectable
                  residual disease.
                  Randomization Eligibility:
                  · Patients must be confirmed eligible by central review of pathology, and must
                  have completed 1p/19q deletion assessment.
                  · Patients must be able to start RT within 2 weeks or 10 working days at a
                  qualified center and able to start TMZ at a qualified center within 2 weeks or 10
                  working days of randomization.
                  · Patients must not be pregnant or breastfeeding; women of childbearing potential
                  and sexually active males are strongly advised to use an accepted and effective
                  method of contraception.
                  · Patients must be at least two weeks post any brain surgery (whether stereotactic
                  biopsy, open biopsy or resection) at the time of randomization
                                                                                                                                                                                       5

                                                                                         BREAST
         TITLE                                                ELIGIBILITY                                                          TREATMENT                              LOCATION
                             Patients must have stage 0, I, or II breast cancer.                                Group 1:
IRB# 6389: NSABP B-           If stage II, tumor size must be <3 cm.                                            Whole Breast Irradiation (WBI)                            LSUHSC
39/RTOG 0413: A                                                                                                 45-50 Gy in 25 (1.8-2.0 Gy) fractions to whole
Randomized Phase III                                                                                                                                                      MBPCC
                           breast.                                                                              breast, followed by optional boost to > 60 Gy
Study of                                                            lumpectomy with clean margins (see Sec.                                                               CCS
Conventional Whole         6.1.6).                                                                              Group 2:
Breast Irradiation                                                                                              Partial Breast Irradiation (PBI)                          Oncologics
(WBI) Versus Partial       6.1.7).                                                                              34 Gy in 3.4 Gy fractions using multi-catheter
Breast Irradiation                                                                                              brachytherapy
(PBI) for Women with                                                               es, and no positive non-     Or
Stage 0, I, or II Breast   axillary sentinel node(s) are allowed.                                               34 Gy in 3.4 Gy fractions using MammoSite®
Cancer                                                                                                          balloon catheter
                           cancer.                                                                              Or
                                                                                                                38.5 Gy in 3.85 Gy fractions using 3D conformal
                                                          must be delineated and target reference volume        external beam radiation
                           must be <30%.
                                               -breast malignancies are eligible if disease-free for >5 years   For all PBI techniques: RT given to index quadrant
                           (see Sec. 6.1.14)                                                                    only, BID (with a fraction separation of at least 6
                                                                                                                hours), for a total of 10 treatments given on 5 days
                                                                         ary, supraclavicular,                  over a period of 5-10 days)
                           infraclavicular or internal mammary nodes, or microcalicifications, densities, or    *******************************************************
                           palpable abnormalities must be biopsy-proven negative (see Secs. 6.2.5 and           If chemotherapy is to be given (at the discretion of
                           6.2.6).                                                                              the patient’s medical oncologist), it will be given
                                                                                                                prior to WBI (Group 1) or following PBI (Group 2).
                                                                                                                At least 2 weeks should separate the two
                                                                                                                modalities.
                                                                                                                If hormone therapy is to be given, it should begin
                                                                                                                between 3 and 12 weeks after the completion of
                                                                                                                any chemotherapy. In patients not receiving
1 rx credit                                                                                                     chemotherapy, hormones may begin before, during
0.5 cc credit
                                                                                                                or after radiation.
                                                                                                                                                                      6
                                                                               BREAST
                                                                                                                          TREATMENT
         TITLE                                         ELIGIBILITY                                                                                        LOCATION
                              Only patients who had a lumpectomy are eligible. Re-excision(s) to
NSABP B-43: A                  achieve tumor-free margins are permitted, but mastectomy is not.          Group 1*: Radiation Therapy                      MCLNO
Phase III Clinical Trial      Pre-entry central HER2 testing (see Sections 6.1 and 6.2 and Appendix
Comparing                                                                                                Group 2*: Radiation Therapy + Trastuzumab x 2    Veith
                               C) is required for all patients.
Trastuzumab Given                                                                                        doses
                              Patients must have an ECOG performance status of 0 or 1                                                                    MOL
Concurrently with             On histologic examination, the tumor must be ductal carcinoma in situ     Dose 1: 8 mg/kg IV
Radiation Therapy              (DCIS). (Patients with mixed DCIS and lobular carcinoma in situ [LCIS]                                                     MBPCC
and Radiation                  are eligible.) The DCIS must be HER2-positive as determined by            Dose 2: 6 mg/kg IV
Therapy Alone for              central testing                                                                                                            CCS
Women with HER2-              Estrogen and/or progesterone receptor status must be determined prior     given 3 weeks after Dose 1                       Thibodaux
Positive Ductal                to randomization. (Patients with DCIS that is hormone receptor positive
Carcinoma In Situ              or negative are eligible.)
Resected by                   All DCIS must have been resected by lumpectomy. The margins of the        Trastuzumab will be provided free of charge by
Lumpectomy                     resected specimen must be histologically free of DCIS. For patients in    Genentech, Inc., and distributed by the NCI
                               whom pathologic examination demonstrates DCIS present at the line of      Pharmaceutical Management Branch (PMB).
                               resection, re-excision(s) may be performed to obtain clear margins.
                               (Patients who require mastectomy are not eligible.)
                              If axillary staging is performed, nodal staging must be pN0, pN0(i–),
                               pN0(i+) which is defined as isolated tumor cells ≤ 0.2 mm, regardless
                               of the method of detection, i.e., IHC or H&E, pN0(mol–), or pN0(mol+).
                               Note: Axillary staging is not required.
                              The interval between the last surgery for excision of DCIS (lumpectomy
                               or reexcision of lumpectomy margins) and randomization must be no
                               more than 120 days.




1 rx credit
                                                                                                                                                                       7
                                                                               BREAST
         TITLE                                     ELIGIBILITY                                                             TREATMENT                           LOCATION
                           Patients with histologically-confirmed, nonmetastatic, operable primary
N063D/BIG 2-06,            invasive adenocarcinoma of the breast.                                         Treatment Plan                                       MCLNO
ALTTO: Adjuvant            · Tumor must be adequately excised (see Section 4.2.3.b for
Lapatinib and/or                                                                                          See Section 5.0 for Complete Treatment Details       Veith
                           exception).
Trastuzumab                · Axilla must be dissected; patients must be axillary node positive or        Design 2                                             MOL
Treatment                  node negative with a tumor ≥ 1.0 cm.
Optimization Study:        · Hormone receptor status must be known (ER/PgR or ER alone).                 Trastuzumab Arm                                      MBPCC
A randomized, multi-       · Patients must have received at least four cycles of an approved             · Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with
centre, open-label,                                                                                                                                            EKL
                           anthracycline-based (neo-) adjuvant chemotherapy regimen (see                  Trastuzumab 2mg/kg* IV q 7 days x 12 weeks,
phase III study of         Section 4.1, Table 5 of the protocol).                                                                                              CCS
                                                                                                          followed by Trastuzumab 6mg/kg IV q 21 days x 40
adjuvant lapatinib,        · There must be over expression and/or amplification of HER2 in the           weeks
trastuzumab, their         invasive component of the primary tumor which must be confirmed by
sequence and their         the central laboratory prior to randomization.                                 Lapatinib Arm
combination in             · Patients must not have a history of any prior (ipsi and/or contralateral)
patients with              invasive breast carcinoma.                                                     · Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with
HER2/ErbB2 positive        · Patients must not have bilateral tumors.                                    Lapatinib 1500 mg PO QD x 52 weeks Trastuzumab
primary breast             · Patients must not have a clinically staged T4 tumor, including              followed by Lapatinib Arm · Paclitaxel 80 mg/m2 IV
cancer                     inflammatory breast cancer.                                                    q 7 days x 12 weeks, with Trastuzumab 2 mg/kg* IV
                           · Patients must not have had (neo-) or adjuvant chemotherapy using            q 7 days x 12 weeks 6-week washout, followed by
                           peripheral stem cell or bone marrow stem cell support.                         Lapatinib 1500 mg PO QD x 34 weeks
                           · Patients must not have had any prior mediastinal irradiation except         Lapatinib combined with Trastuzumab Arm
                           internal mammary node irradiation for the present breast cancer.
                           · Patients must not have positive or suspicious internal mammary              · Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with
                           nodes identified by sentinel node technique which will have not been           Lapatinib 750 mg PO QD x 12 weeks, and ·
                           irradiated or will not be irradiated, nor supraclavicular lymph node           Trastuzumab 2mg/kg* IV q 7 days x 12 weeks,
                           involvement (confirmed by FNA or biopsy).                                      followed by Lapatinib 1000 mg PO QD x 40 weeks,
                           · Patients must not have had prior use of anti-HER2 therapy for any           with Trastuzumab 6mg/kg IV q 21 days x 40 weeks
                           reason or other prior biologic or immunotherapy for breast cancer.
                                                                                                          * A loading dose of trastuzumab is given on Day
                           · Patients must not have concurrent anti-cancer treatment, except
                                                                                                          1that is
                           hormonal therapy or radiotherapy for the present breast cancer.
                                                                                                          2 mg/kg higher than the regular dose shown
                                                                                                          here.




1 rx credit
                                                                                                                                                       8
                                                                                 BREAST
         TITLE                                         ELIGIBILITY                                                         TREATMENT          LOCATION
CALGB 70604: A           •    Histo confirmed adenocarcinoma of prostate or breast or multiple             zoledronic acid (every 12 weeks)   MBPCC
Randomized, Phase        myloma                                                                            versus                             Veith
III Study of Standard        At least 1 bone mets confirmed by radiographic imaging                       zoledronic acid (every 4 weeks)    CCS
Dosing versus                No prior IV bisphosphonate tx                                                                                   LSUHSC
Longer Dosing                No prior radiopharmaceuticals                                                                                   MOL
Interval of Zoledronic       ≥ 4 week since completion of radio-therapy                                                                      MCLNO
Acid in Metastatic           No current investigational therapy
Cancer                       No brain mets
                             ECOG status of 0-2
1 cc credit

IRB# 7310: Z1071: A           ECOG/Zubrod Performance Status 0-1                                          Surgery followed by chemo          MBPCC
Phase II Study                Histologic diagnosis of invasive breast cancer, clinical stage T1-4 N1-2                                       Veith
Evaluating the Role              (excluding inflammatory breast cancer).                                                                      CCS
of Sentinel Lymph             FNA biopsy or core needle biopsy of an axillary node documenting                                               LSUHSC
Node Surgery and                 nodal disease at time of diagnosis and prior to preoperative                                                 MOL
Axillary Lymph Node              chemotherapy.                                                                                                MCLNO
Dissection Following          Preoperative chemotherapy must be completed or planned for patient.
Preoperative                  Non-pregnant and non-lactating (breast feeding).
Chemotherapy in               No prior ipsilateral axillary surgery, such as excisional biopsy of lymph
Women with Node                  node(s) or treatment of hidradenitis.
Positive Breast               No prior SLN surgery/excisional lymph node biopsy for pathological
Cancer (T1-4, N1-2,              confirmation of axillary status.
M0) at Initial
Diagnosis

1 rx credit
                                                                                                                                                                               9
                                                                                 BREAST
       TITLE                                        ELIGIBILITY                                                                TREATMENT                            LOCATION
                                                                                                            Arm I:                                                 MBPCC
CALGB 40503                                                                                                                                                         CCS
                           breast in either primary or metastatic setting; It must be Stage IV disease or
Endocrine Therapy in       Stage IIIB disease not amenable to local therapy.                                 Endocrine therapy*                                     Veith
Combination with          Tumors must be either ER and/or PgR positive.                                     Bevacizumab 15 mg/kg IV q 21days                       EKL- pending
ANTI-VEGF Therapy: A      Patients may be postmenopausal (per criteria in Section 4.5.2) or must undergo                                                           MCLNO-
Randomized, Double-        ovarian suppression (per Section 8.3) starting prior to or on day 1 of protocol   Ovarian suppression if required#                       pending
Blind, Placebo-            therapy.                                                                          Continue until progressive disease
Controlled Phase III      Patients must have measurable or non-measurable disease by RECIST criteria
Trial of Endocrine         (per Section 4.6).
                          Patients may not have had prior endocrine therapy in the metastatic setting,      Arm II:
Therapy Alone or
Endocrine Therapy
                           unless tamoxifen or an AI was started within 4 weeks prior to registration to     Endocrine therapy*
                           facilitate the enrollment of patients who recently started 1st-line endocrine
Plus Bevacizumab           therapy for metastatic breast cancer.                                             Ovarian suppression if required#
(NSC 704865; IND          Patients may have had prior endocrine therapy in the adjuvant setting.            Continue until progressive disease
7921) for Women           Patients may have had prior treatment with ovarian suppression in either the
with Hormone               adjuvant or metastatic setting (see Section 7.7.1).
Receptorpositive                         not have had any prior anti-VEGF or VEGFR tyrosine kinase          *The choice of endocrine therapy (letrozole or
Advanced Breast            inhibitor therapy.                                                                tamoxifen) is up to the treating physician (see
                          Any prior RT must have been completed and all toxicities resolved at least two    Section 8.3 for recommendations).
Cancer
                           weeks prior to registration.
                                                                                                             # Ovarian suppression for premenopausal women
                          Patients may have had chemotherapy in the adjuvant or neoaduvant setting.
                           Any prior chemotherapy must have been completed at least 12 months prior to       must be medical or surgical (not via radiation). See
   1   rx credit           registration, and all toxicities must have resolved.                              Section 8.4 for choices of LHRH agonists.
                          Taxane-related neurotoxicity must have resolved to sensory grade < 2 and no
                           motor neuropathy of any grade is allowed.
                                    may have received one prior chemotherapy regimen for metastatic
                           disease.
                          Treatment with bisphosphonates is allowed and recommended per ASCO
                           guidelines.
                                          not have had any major surgical procedure, open biopsy, or
                           significant traumatic injury
                          within 28 days prior to study registration, and must have fully recovered from
                           such procedures.
                          Patients must not anticipate any major surgery during the course of the study.
                          Patients must not have had a core biopsy or other minor surgical procedure
                           within 7 days prior to registration (VAD placement is allowed within 7 days of
                           registration).
                                          not have history of abdominal fistula, intra-abdominal abscess,
                           or significant bleeding episodes (e.g., hemoptysis, upper or lower GIB) within
                           6 months prior to registration or a history of GI perforation within 12 months
                           prior to registration.
                          Patients must not have clinically significant CV disease, including
                           uncontrolled HTN
                          4.12.1), history of MI or unstable angina within 6 months, NYHA Grade 2 or
                           greater CHF,
                          symptomatic PVD, or significant vascular disease or arterial thrombotic events.
                                      may be on full dose anticoagulation for prior conditions such as
                           venous thrombosis or atrial
                          fibrillation, but not for the treatment of prior arterial thrombotic events;
                                                                                                                                                                        10

                                                                         CANCER CONTROL
         TITLE                                        ELIGIBILITY                                                       TREATMENT                             LOCATION
                                            See specific disease site for current cancer control studies.

                                                                  GASTROINTESTINAL
              TITLE                                      ELIGIBILITY                                                     TREATMENT                            LOCATION
IRB# 6736: SWOG C80405:         · Patients with histologically or cytologically documented locally       Arm A:                                              LSU
A Phase III Trial Of                advanced or metastatic adenocarcinoma of the colon or rectum that                                                         MBPCC
Irinotecan/5-Fu/Leucovorin          has not been resected.                                                                                                    Med Onc
Or Oxaliplatin/5-               · Patients may have a history of colorectal cancer treated by surgical                                                       EKL
Fu/Leucovorin With                  resection and now have evidence of metastatic cancer.                                                                     MCLNO
Bevacizumab, Or                 · Patients must have a wildtype K-ras gene as determined by the          Arm B                                               CCS
Cetuximab (C225), Or With           SWOG Solid Tumor Repository.
The Combination Of              · Patients may not have received any prior systemic treatment for        Cetuximab 250mg/m2 IV Weekly thereafter
Bevacizumab And                     advanced or metastatic disease, but may have received prior
Cetuximab For Patients              adjuvant chemo that concluded > 12 months prior to registration or
With Untreated Metastatic           prior neoadjuvent chemo-radiation with capecitabine or 5-FU.
Adenocarcinoma Of The           · No prior exposure to agents that target VGEF or EGF receptors; no
                                    prior exposure to bevacizumab or Cetuximab.                           *The decision to use FOLFOX or FOLFIRI is at the
Colon Or Rectum                                                                                           patient/treating physician’s discretion (while
                                · Patients may not have had prior RT to greater than 25% of bone
                                    marrow.                                                               complying with eligibility criteria 4.5 and 4.6).
                                · No major surgery < 4 weeks prior.
                                · Patients to receive FOLFIRI may not have evidence of Gilbert’s         Cetuximab is provided free of charge
                                    Syndrome or be known to be homozygous for the UGT1A1*28 allele,
                                    and those to receive FOLFOX may not have sensory peripheral
                                    neuropathy of > grade 2 at baseline.
1 rx credit
 E3205: Phase II Trial of           histologically proven stage I-IIIB invasive anal canal or            Cetuximab Plus Cisplatin, 5-Fluorouracil and        MBPCC
Cetuximab Plus Cisplatin,            perianal (anal margin) squamous cell carcinoma                       Radiation                                           Med Onc
5-Fluorouracil and                  must be > 18 years                                                                                                       Veith
Radiation in                        ECOG performance status of 0-2                                                                                           MCLNO
Immunocompetent                     No concurrent malignancies                                           Cetuximab is provided free of charge                EKL
Patients with Anal                  no history of prior radiation or chemotherapy for this                                                                   CCS
Carcinoma                            malignancy
                                    must not have had prior potentially curative surgery
                                     (abdominal, peritoneal resection) for carcinoma of the anus
                                    must not have an active infection, uncontrolled diabetes,
                                     congestive heart failure > NYHA Class II, CVA/TIA,
                                     uncontrolled hypertension, unstable angina or myocardial
1 rx credit                          infarction within the last 6 months
                                    no hx of rheumatic disorders, irritable bowel disease, or
                                     inflammatory bowel disease
                                    no HIV
                                    see protocol for labs
                                                                                                                                                                            11
CALGB 80702: A Phase         Documented adenocarcinoma of the colon and at least one pathologically          Treatment must begin between 21 and 56 days            EKL
III Trial of 6 versus 12    confirmed positive lymph node.                                                   after definitive surgical resection of primary tumor
                            · Patients must not have rectal cancer (i.e., the tumor must be at least 12      and within 14 days of randomization.                   MBP
Treatments of Adjuvant
FOLFOX Plus Celecoxib
                            cm from the anal verge).                                                         One cycle = 14 days of treatment                       CCS
                            · Patients must have had complete resection of the tumors; if tumor is
or                          adherent to adjacent structures, patients must have documentation of en
                                                                                                                                                                    Veith
                                                                                                             Medications:
Placebo for Patients with   bloc R0 resection.                                                               FOLFOX:                                                MCLNO
Resected Stage III Colon    · Patients must not have any evidence of residual involved lymph node            Oxaliplatin 85 mg/m2 IV over 2 hours followed by
Cancer                      disease or metastatic disease at the time of registration.                       Leucovorin 400 mg/m2 IV over 2 hours (may be
                            · Patients may have synchronous colon cancers, but must not have                 administered concurrently via separate infusion
1 tx credit                 synchronous colon and rectal primary tumors.                                     lines) followed by
                            · Patients must not use NSAIDs at any dose or aspirin at > 325 mg more           5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 con-
                            than two times per week on average (low dose aspirin, ≤ 100 mg/day is            tinuous IV infusion over 46-48 hours.
                            permitted).
                            · Patients must not have previous or concurrent malignancy, except treated       Celecoxib: 400 mg daily PO
                            basal cell or squamous cell skin cancer, treated in situ cervical cancer,        Arm A: 12 cycles of FOLFOX + Placebo daily
                            treated lobular or ductal carcinoma in situ in one breast, or any other cancer
                                                                                                             Arm B: 12 cycles of FOLFOX + Celecoxib daily
                            for which the patient has been disease free for ≥ 5 years.
                                                                                                             Arm C: 6 cycles of FOLFOX + Placebo daily
                            · Patients must not have neurosensory or neuromotor toxicity ≥ grade 2 at
                                                                                                             Arm D: 6 cycles of FOLFOX + Celecoxib daily
                            time of registration.
                            · Patients must not have known allergy to platinum compounds, or prior           Celecoxib/placebo will continue for 3 years or until
                                                                                                             unacceptable toxicity.
                            allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs.
                            · Patients must not have a history of upper GI ulceration, bleeding or
                            perforation within the past 3 years.
                            · Patients must not have symptomatic pulmonary fibrosis or interstitial
                            pneumonitis ≥ grade 2.
                            · Patients must not have cardiac risk factors, including uncontrolled high
                            blood pressure (systolic BP >150), unstable angina, history of documented
                            myocardial infarction or cerebrovascular accident; or NYHA class II or IV
                            heart failure.
                            · ECOG performance status 0, 1, or 2.
                                                                                                                                                                         12
NSABP PROTOCOL P-5        Selected eligibility criteria:                                                 P-5 study therapy                                       MBP
Statin Polyp Prevention   • Resected adenocarcinoma of the colon staged as AJCC StageI or II             • Each patient will take 1 tablet of the P-5 study
                                                                                                         drug once daily for 5 years. Patients will take         EKL
Trial in Patients         • Surgical resection of the colon adenocarcinoma with curative intent within
with Resected Colon       1 year prior to randomization (laparoscopicallyassisted colectomy is           either:                                                 CCS
Cancer                    permitted)                                                                     − rosuvastatin 10 mg (one tablet) orally without        Veith
                          • Patients must > 18 years old                                                 regard to meals, once a day for 5 years, or
                                                                                                         − placebo (one tablet) orally without regard to         MCLNO
1cc credit                • Adjuvant therapy, if given, must be completed before randomization
                                                                                                         meals, once a day for 5 years.
                          • Patients taking cardioprotective low-dose aspirin must be able and willing
                          to continue at the same dose                                                   This is a double-blind trial. Neither the patient nor
                          • Colonoscopy (preop or postop) to the cecum or small bowel anastomosis        the investigator/health care providers will
                          with removal of all observed polyps within 180 days prior to randomization     know the treatment assignment until the
                          • Within 90 days prior to randomization:                                       completion of the trial.
                          o Serum creatinine must be < 1.5 x ULN
                          o AST or ALT < 3.0 x ULN and total bilirubin must be < 1.5 x
                          ULN (If AST & ALT obtained, both must be < 3.0 x ULN)
                          Selected ineligibility criteria:
                          • Tumor with the distal border located <12 cm from the anal verge
                          • Total colectomy or total proctocolectomy
                          • Classic Familial Adenomatous Polyposis, Attenuated Familial
                          Adenomatous Polyposis, or Hereditary Nonpolyposis Colorectal Cancer
                          (Lynch Syndrome)
                          • Statin use within 30 days prior to randomization
                          • Hyperlipidemia with clinical indication for statin therapy
                          • Chronic use of therapeutic aspirin (doses > 325 mg) or use of NSAIDs for
                          more than an average of 3 days per month
                          • Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease,
                          resection of the stomach or small bowel, or other disease significantly
                          affecting GI function
                          • Hypersensitivity or intolerance to statins
                          • Unwillingness to discontinue chronic use of NSAIDs other than
                          cardioprotective low-dose aspirin
                                                                                                                                                                                   13
IRB # 7647C: CALGB                                                                                                   Arm A:                                              MBPCC
80802 Phase III             fibrolamellar variant is not allowed.                                                                                                        CCS
                                                                                                                     Doxorubicin 60 mg/m2 IV Day 1
randomized study of                                                                                                                                                      Veith
                            defined as disease deemed to be unresectable or non-eligible for transplant without      May give G-CSF x three days or GM-CSF x one
sorafenib (IND 69896,                                                                                                                                                    EKL-
NSC 724772) plus
                            distant metastases.                                                                      day after each doxorubicin dose                     pending
doxorubicin versus          dimension as ≥ 2 cm with conventional techniques or ≥ 1 cm with spiral CT scan.          Sorafenib 400 mg PO BID QD                          MCLNO-
sorafenib in patients                                                             b or other Raf/VEGF inhibitors.    Give six 21-days cycles of doxorubicin and          pending
with advanced               Other prior adjuvant therapy is allowed if completed > 6 months prior to study entry
                                                                                                                     sorafenib, and then continue sorafenib until
hepatocellular              with documented recurrence of HCC.
                                                                                                                -    unacceptable toxicity or disease progression.
carcinoma (HCC)
                            embolization (except with doxorubicin), radiation, radioactive microspheres, etc.,
THERAPEUTIC CREDITS:        provided that they either have a target lesion that has not been subjected to local      Arm B:
                            therapy and/or the target lesion(s) within the field has shown an increase of ≥ 25% in
1.7 TOTAL (1.0 for 80802
                            size since last treatment. Such therapy must be completed ≥ 4 weeks prior to study       Sorafenib 400 mg PO BID QD
study; 0.3 for 150902
Ancillary; 0.3 for 580901
                            entry.                                                                                   Continue sorafenib until unacceptable toxicity or
Ancillary; 0.1 for 60901                                                                                             disease progression.
Ancillary)
                            4 weeks prior to registration.
CANCER CONTROL
                              no prior history of allograft, including liver and bone marrow transplants.
CREDITS: 0

                            intervention,
                            transfusion, or admission to hospital within 30 days prior to study entry.


                            Wort; these drugs should be discontinued ≥ 4 weeks prior to starting protocol
                            treatment.
                                                                       -controlled on an anti-HTN regimen.

                            within 6 months prior to study entry, cardiac arrhythmias requiring therapy other
                            than beta-blockers or digoxin, or serious myocardial dysfunction (i.e., LVEF < 45%
                            or < institutional normal level).

                                                                       ion ART for HIV.

                            males must agree to use adequate contraception prior to the initiation of study
                            treatment, for the duration of the study participation, and for 30 days after
                            completing study
                                                                                       -2.
                                                                                                                                                                        14
NCCTG N08CB A                   Histologically confirmed adenocarcinoma of the colon or rectum. Has              Calcium gluconate plus magnesium             Veith
                                 undergone curative resection and is considered to have stage II orstage III       sulfate 1 g of each agent IV in 100 ml
Phase III                        disease or completely resected stage IV disease with no evidence of
                                                                                                                                                                MCLNO
                                                                                                                   D5W over 30 minutes immediately
Randomized,                      residual tumor.
                                                                                                                   before and after each oxaliplatin
Placebo-Controlled,             Scheduled to receive 6 months of oxaliplatin-based adjuvant chemotherapy
                                                                                                                   administration
                                 with 85 mg/m2 oxaliplatin every 2 weeks. This includes, for instance,
Double-Blind Study               FOLFOX4 or modified FOLFOX Note: Adjuvant FOLFOX can be
of Intravenous                   conducted with or without bolus 5FU.                                             Placebo 100 ml bag of D5W IV over 30
Calcium/Magnesiu      Definitions                                                                                  minutes immediately before and after
                      FOLFOX4: 2-hour infusion of LV (200 mg/m2/d) with oxaliplatin                                each oxaliplatin administration
m in Two Different    85 mg/m2 as a 2-hour infusion on day 1; followed by a 5FU bolus (400 mg/m2/d)
Versions to Prevent   and                                                                                         Calcium gluconate plus magnesium
Oxaliplatin-Induced   22-hour infusion (600 mg/m2/d) for 2 consecutive days every 2 weeks                          sulfate 1 g of each agent in 100 ml bag of
                      MODIFIED FOLFOX6: 2-hour infusion of LV (400 mg/m2) with oxaliplatin 85
Sensory               mg/m2 as a 2-hour infusion on day 1 followed by a 5FU bolus (400 mg/m2) and 46-
                                                                                                                   D5W IV over 30 minutes Immediately
Neurotoxicity         hour infusion (2400 mg/m2) every 2 weeks                                                     before each oxaliplatin administration
                      Note: Patients using bevacizumab or cetuximab in combination with FOLFOX as                  PlaceboImmediately after each
                      part of a clinical trial or clinical practice are eligible.                                  oxaliplatin administration
                                The following laboratory values obtained ≤28 days prior to registration:
CANCER CONTROL                    WBC ≥3000, ANC ≥1500, PLT ≥100,000, HgB ≥10.0, Total bilirubin
CREDITS:  1.0         ≤1.5 x upper normal limit (UNL), Serum creatinine ≤1.5 x UNL, Serum calcium ≤
                      1.2 x UNL, Serum magnesium ≤ 1.2 x UNL
                                Negative pregnancy test (serum or urine) done ≤ 7 days prior to
                                 registration, for women of childbearing potential only.
                                Ability to complete questionnaire(s) by themselves or with assistance.
                                ECOG Performance Status (PS) of 0, 1 or 2.
                                Willingness to return to enrolling institution for follow-up.
                                 Patient willing to provide blood sample for research purposes (see
                                 Sections 6.12 and 14.0).
                                Central venous access line present, or scheduled to have a central line
                                 placed prior to starting chemotherapy and protocol treatment.
                       Exclusion Criteria Any of the following:
                      Pregnant women,nursing women, men or women of childbearing potential who are
                      unwilling to employ adequate contraception since this study involves agents that
                      have known genotoxic, mutagenic and teratogenic effects
                      Pre-existing peripheral neuropathy of any grade.
                       Prior treatment with neurotoxic chemotherapy such as oxaliplatin, cisplatin, taxanes,
                      or vinca alkaloids.
                      On digitalis medication.
                      2nd or 3rd degree AV heart block or a history of 2nd or 3rd degree AV heart block.
                      Note: Bundle branch blocks are allowed.
                      Treatment with 1) the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin
                      (e.g., Dilantin®), valproic acid (e.g. Depakene®), gabapentin (Neurontin®);
                      pregabalin (Lyrica®); 2) the following neurotropic agents: venlafaxine (Effexor),
                      desvenlafaxine (Pristiq®), milnacipran (Savella®) or duloxetine (Cymbalta); 3)
                      Tricyclic antidepressants (such as amitryptilline) or 4) any other agent specifically
                      being given to prevent or treat neuropathy.
                      A family history of a genetic/familial neuropathy.
                                                                                                                                                                     15
ECOG E7208 A           Histologically documented adenocarcinoma (including the histologic variants of         Treatment/ARM A                              MBPCC
                       adenocarcinoma) of the colon or rectum.Patients K-ras status must be wild type
Randomized Phase II    (not mutated). K-ras status determination may bebased on either primary or             Cetuximab 500 mg/m2 IV q 14 days
                                                                                                                                                           CCS
Study of Irinotecan    metastatic tumor.                                                                                                                   EKL-
                                                                                                              Irinotecan 180 mg/m2 IV over 60-90 minutes q
and Cetuximab with     Patients must have had prior first-line therapy with oxaliplatin-based                                                              pending
or without the Anti-   fluoropyrimidinecontaining chemotherapy and bevacizumab for metastatic                 14 days                                      Veith
                       colorectal cancer.
Angiogenic Antibody,   Registration within 42 days of documented disease progression.                         Repeat cycles every 14 days until            MCLNO-
Ramucirumab, in        Registration within 90 and no fewer than 28 days of last dose of bevacizumab.          progression.                                 pending
Advanced, K-ras        Performance Status 0-1.
Wild-type Colorectal    Adequate Organ Function < 4 weeks prior to registration.                              Treatment/ARM B
                       Hematologic: Absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and
Cancer Following                                                                                              Ramucirumab 8 mg/kg IV over 60 minutes q
                       platelets ≥ 75,000/μL.
Progression on         Renal: Serum creatinine ≤ 1.5 x the ULN, or creatinine clearance (measured via 24-     14 days. The dose of ramucirumab is to be
Bevacizumab-           hour urine collection) ≥ 40 mL/minute.
                       Proteinuria: Urinary protein ≤ 1+ on dipstick or routine urinalysis (UA); if urine     recalculated should the patients
Containing
Chemotherapy
                       dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must      weight change by 10%
                       demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.
                       Hepatic: Total bilirubin ≤ 2.0 mg/dL, and aspartate transaminase (AST) and alanine     Cetuximab 500 mg/m2 IV q 14 days
1Tx credit             transaminase (ALT) ≤ 3.0 x the upper limit of normal (ULN) [or 5.0 x the ULN in the
                                                                                                              Irinotecan 180 mg/m2 IV over 60-90 minutes q
                       setting of liver metastases].
                       Coagulation: International Normalized Ratio (INR) ≤ 1.6 (unless receiving              14 days
                       anticoagulation therapy). Patients on full-dose anticoagulation must be on a stable
                       dose (minimum duration 14 days) of oral anticoagulant or low molecular weight          Ramucirumab should be given first, followed
                       heparin. If receiving warfarin, the patient must have an INR ≤ 3.0 and no active       by cetuximab and then irinotecan.
                       bleeding (ie, no bleeding within 14 days prior to first dose of study therapy).
                       No prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus         Repeat cycles every 14 days until
                       bevacizumab for this diease. If oxaliplatin is discontinued because of side effects,
                                                                                                              progression.
                       patients must have continued on bevacizumab (normally with a fluoropyrimidine).
                       No clinically significant (equivalent to NCI CTCAE grade 3-4) bleeding episodes
                       within the prior 3 months.
                       No active infection, symptomatic congestive heart failure, unstable angina pectoris,
                       symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or
                       hemorrhagic disorder.
                       No uncontrolled or poorly-controlled hypertension despite standard medical
                       management (e.g. consistently SBP > 160 and DBP > 90 mmHg).
                       No major surgery within 28 days prior to randomization, or subcutaneous venous
                       access device placement within 7 days prior to randomization
                       No history of acute arterial thrombotic events within 6 months (including CVA, TIA,
                       MI or unstable angina).
                       No brain or CNS metastases.
                       No other cancer requiring therapy within last three years (except in situ carcinoma
                       or nonmelanoma skin cancer).
                       Patients must not have an acute or subacute intestinal obstruction.
                       Patient must not have a history of inflammatory bowel disease requiring
                       pharmacological and/or surgical intervention within the 12 months prior to
                       randomization.
                       Patient must not have a known allergy to any of the treatment components.
                                                                                                                                                                       16




                                                                      GENITOURINARY
        TITLE                                    ELIGIBILITY                                                           TREATMENT                               LOCATION
R0534: A Phase III        Patients must have adenocarcinoma of the prostate treated primarily      Arm 1:                                                     MBPCC
Trial Of Short-term        with radical prostatectomy, pathologically proven to be LN negative by   PBRT alone RT to prostate bed to 64.8-70.2 Gy              CCS
Androgen                   pelvic lymphadenopathy (pN0) or LN status pathologically unknown
Deprivation With           (undissected pelvic LNs [pNx])                                           Arm 2:
Pelvic Lymph Node         Post-prostatectomy PSA of ≥ 0.1 and < 2.0 ng/mL                          PRBT plus NC-STAD LHRH agonist injections to
Or Prostate Bed-Only      Disease must be pathologic T3N0/Nx or pathologic T2N0/Nx with or         cover 4-6 months
Radiotherapy               without a positive prostatectomy margin.                                    E.g., leuprolide, goserelin, triptorelin Antiandrogen
(SPORT) In Prostate       There must be no distant metastases.                                     for 4-6 months
Cancer Patients With      Patients must not have a palpable prostatic fossa abnormality or mass       Flutamide or bicalutamide
A Rising PSA After         suggestive of recurrence, unless it has been shown by biopsy under       RT to prostate bed to 64.8-70.2 Gy beginning 2
                           US guidance not to contain cancer.                                       months after start of drug therapy
Radical
Prostatectomy             Patients must not have N1 disease or pelvic LN enlargement ≥ 1.5 cm
                           in greatest dimension by CT or MRI of the pelvis (unless proven          Arm 3:
                           negative by biopsy).                                                     PLNRT plus PBRT plus NC-STAD LHRH agonist
                          Patients must not have received androgen deprivation therapy that        injections to cover 4-6 months
                           was started prior to prostatectomy for > 6 months duration.                  E.g., leuprolide, goserelin, triptorelin
                          Patients must not have received androgen deprivation therapy that        Antiandrogen for 4-6 months
                           was started after prostatectomy and prior to registration.                   Flutamide or bicalutamide
                          Patients must not have had prior pelvic radiotherapy.                    RT to pelvic lymph nodes to 45 Gy beginning 2
                                                                                                    months after start of drug therapy
                                                                                                    RT to prostate bed to 64.8-70.2 Gy beginning 2
                                                                                                    months after start of drug therapy

                                                                                                    PBRT = prostate bed radiation therapy
                                                                                                    PLNRT = pelvic lymph node radiation therapy
                                                                                                    NC-STAD = neoadjuvent and concurrent short term
1.5 rx credits                                                                                      androgen deprivation.
                                                                                                                                                                 17
                                                                         GENTOURINARY
         TITLE                                               ELIGIBILITY                                               TREATMENT                          LOCATION
CALGB-90202: A                 Histologic documentation of prostate adenocarcinoma (see sec 5.1)     Double-Blinded                                    MBPCC
Randomized, Double-            At least one bone metastasis by radiographic imaging (see sec 5.2)       Zoledronic acid: 4 mg IV Q 4 wks              LSUHSC
Blind, Placebo-                Patients must receive androgen deprivation therapy for treatment of   or                                                Veith
Controlled Phase III            prostate CA (see sec 5.3)                                                Placebo: IV Q 4 wks                           MOL
Study of Early versus          Hormone therapy (HT) at any point prior to 6 mos before enrollment                                                      CCS
Standard Zoledronic             is prohibited (see sec 5.4)                                           Patients who experience PD* during the double     MCLNO
Acid to Prevent                Prior neoadjuvant and/or adjuvant HT is allowed provided that the     blind portion:
Skeletal Related                duration of HT was < 6 mos and HT was discontinued > 6 mos prior          Open label Zoledronic acid 4 mg IV Q 3 wks
Events in Men with              to study entry
Prostate Cancer                No prior treatment with a bisphosphonate or with                      Patient who experience an SRE** at any time
Metastatic to Bone              radiopharmaceuticals                                                  during the study:
                               ≥ 4 wks since completion of prior RT                                  
                               ECOG (CTC) performance status 0-2
1 rx credit                                                                                           *PD: Progressive disease
                                                                                                      **SRE: Skeletal-related event




CALGB 70604: A          •       Histo confirmed adenocarcinoma of prostate or breast or MM            zoledronic acid (every 12 weeks)                  MBPCC
Randomized, Phase III          At least 1 bone mets confirmed by radiographic imaging                versus                                            Veith
Study of Standard              No prior IV bisphosphonate tx                                         zoledronic acid (every 4 weeks)                   CCS
Dosing versus Longer           No prior radiopharmaceuticals                                                                                           LSUHSC
Dosing Interval of             ≥ 4 week since completion of radio-therapy                                                                              MOL
Zoledronic Acid in             No current investigational therapy                                                                                      MCLNO
Metastatic Cancer              No brain mets
                               ECOG status of 0-1
1 cc credit
                                                                                                                                                                18
                                                                        GENTOURINARY
         TITLE                                              ELIGIBILTIY                                                  TREATMENT                       LOCATION
                                                                                                                                2
CALGB 90601: A               Histologically documented metastatic or unresectable transitional        Gemcitabine 1000mg/m IV on Day 1 and Day        Veith
                                                                                                                                        2
Randomized Double             cell carcinoma of the urinary tract (renal pelvis, ureter, bladder,      8of every cycle, Cisplatin 70mg/m IV on Day 1   MBPCC
Blind Phase III Study         prostate, or urethra), with progressive metastatic or locally advanced   and Placebo 15mg/kg Iv on Day 1 every 21 days   CCS
comparing                     disease. Patients must not be candidates for potentially curative        for 6 cycles then placebo 15mg/kg Iv every 21
Gemcitabine, Cisplatin,       surgery or radiotherapy.                                                 days
and Bevacizumab to           Patients may not have received combination systemic chemotherapy
Gemcitabine, cisplatin        for metastatic disease.                                                  Versus
and Placebo in Patients      For the purposes of this study, radiosensitizng single agent
with Advanced                 chemotherapy is not considered prior systemic therapy.                                         2
                                                                                                       Gemcitabine 1000mg/m IV on Day 1 and Day 8
Transitional Cell            Prior neoadjuvant or adjuvant systemic chemotherapy is permissible                                       2
                                                                                                       of every cycle, cisplatin 70mg/m IV on Day 1,
Carcinoma                     provided the interval from end of therapy to diagnosis of metastatic     and Bevacizumab 15mg/kg IV on Day 1
                              diseases is at least 1 year.                                             Then Bevacizumab 15mf/kg IV every 21 days
1rx credit                   > 4 weeks since any intavesical therapy
                             No prior treatment with bevacizumab or other angiogenesis
                              inhibitors.
                             No known brain metastases: brain imaging not required.
                             No current congestive heart failure: New York Heart Association
                              Class II, III, or IV
                             Patients with a history of hypertension must be well controlled on a
                              regimen of antihypertensive therapy.
                             Patients on full-dose anticoagulants must be on a stable dose
                             No significant history of bleeding events of GI perforation.
                             No arterial thrombotic events within 6 months
                             No serious or nonhealing wound, ulcer or bone fracture
                             ECOG 0-1
IRB #7627 CCCWFU             Male prostate cancer survivor previously treated with                    ArginMax at one of three dose levels:           MBPCC
98110: A                      radiotherapy and who identifies himself as concerned with                 Arm 1: 6 capsules placebo bid                  Veith
Randomized Phase II           sexual quality of life, including erectile dysfunction.                                                                  CCS
                                                                                                        Arm 2: 3 capsules ArginMax & 3
Dose Finding Study           Patient must describe himself as having had successful sexual            capsules placebo BID
of ArginMax for Its           activity prior to the commencement of radiotherapy.                       Arm 3: 6 capsules ArginMax bid
Effect on Erectile           Must be interested in sexual activity, and agree to make at
                                                                                                       All patients will take the assigned
Function and Quality          least one sexual intercourse attempt every week during the
                              study.                                                                   medications twice daily.
of Life in Survivors
of Prostate Cancer            The use of PDE-5 inhibitors will be a voluntary component of            Pill diaries will be provided.
Previously Treated            the trial and will serve as a stratification factor. For patients        All patients will take the same number of
with Radiotherapy             currently taking PDE-5 inhibitors, they must agree to assume             pills daily.
                              the responsibility for the cost of PDE-5 inhibitors treatment
                              during the protocol period (8 week period) as this is not
1cc credit                    covered in the cost of the trial. Patients unable or unwilling to
                              take PDE-5 inhibitors will also be eligible for enrollment on
                              study. PDE-5 inhibitors use will be recorded in the patients‟
                              diaries.
                             Patients taking PDE-5 inhibitors as part of this study must be
                              on a stable dose of drug for at least one month prior to study
                              entry.
                                                                                                                                                            19
CALGB 90203:               Histologic documentation of prostate adenocarcinoma (no small cell,                                                    MBPCC
Randomized Phase III        neuroendocrine, or transition cell allowed).                          Arm A:                                           LSUHSC
Study Of Neo-Adjuvant      · Must have known Gleason sum by biopsy or TURP at registration.             Docetaxel 75 mg/m2 IV Day 1q 21 days x   Veith
Docetaxel And              · Clinical stage T1-T3a and no radiographic evidence of metastatic            6 cycles                                 MOL
Androgen Deprivation        disease.                                                              Concurrently with                                MCLNO
Prior To Radical           · Deemed high risk by either a) Kattan nomogram predicted                    LHRH agonist x 18-24 weeks
Prostatectomy Versus        probability of being free from biochemical progression at 5 years
Immediate Radical           after surgery of < 60% or b) prostate biopsy Gleason sum ≥ 8.         Followed within 60 days by
Prostatectomy In           · No prior treatment for prostate cancer, including surgery (except          Staging pelvic lymphadenectomy
Patients With High-         TURP), LN dissection, radiation, or chemotherapy.                            Radical Prostatectomy*
Risk, Clinically           · May have received up to 3 months of androgen deprivation therapy.
Localized Prostate         · Must be appropriate candidate for radical prostatectomy with life   Arm B:
Cancer                      expectancy of > 10 years as determined by a urologist.                      · Staging pelvic lymphadenectomy
                           · Age > 18 years; ECOG PS 0-1                                               · Radical Prostatectomy*
1.5 rx credits
                                                                                                  Docetaxel supplied free of charge
                                                                                                                                                                         20
                                                                  nosis (via endoscopy or            Arm 1:                                                 Pending facility
RTOG 0436 A       FNA) of primary squamous cell or adenocarcinoma of the esophagus or                Radiation 180 cGy/fx on Days 1-5, 8-12, 15-19, 22-     questionnaire
Phase III Trial   gastroesophageal junction within 12 weeks of registration.                                                                                for MBPCC
                                                                                                     26, 29-33, and 36-38 (total of 50.4 Gy)
Evaluating the                                                                   lavicular           Cetuximab 400 mg/m2 IV on Day 1
Addition of       adenopathy.                                                                        Cetuximab 250 mg/m2 IV on Days 8, 15, 22, 29,
Cetuximab to                                                                                         and 36
Paclitaxel,                                         -4, Any N, M0; Any T, Any N, M1a based on        Paclitaxel 50 mg/m2 IV on Days 1, 8, 15, 22, 29, and
Cisplatin, and    diagnostic workup in Section 3.1.2.                                                36
                                      -4 proximal thoracic esophageal tumors (15-25 cm) must
Radiation for                                                                                        Cisplatin 25 mg/m2 IV on Days 1, 8, 15, 22, 29, and
                  undergo bronchoscopy to exclude fistula; patients must not have evidence of
Patients With     tracheoesophageal fistula or invasion into the trachea or major bronchi.           36
Esophageal                                                                           -2.
Cancer Who Are                                                  eral) of ≥ 1500 kCal/day.            Arm 2:
Treated Without                    not have prior invasive malignancy (except non-                   Radiation 180 cGy/fx on Days 1-5, 8-12, 15-19, 22-
                  melanomatous skin cancer) unless disease free for at least 2 years.                26, 29-33, and 36-38 (total of 50.4 Gy)
Surgery                            not have had prior systemic chemotherapy for esophageal
                                                                                                     Paclitaxel 50 mg/m2 IV on Days 1, 8, 15, 22, 29, and
                  cancer (may have had it for a different cancer).
                                   not have had prior RT that would result in overlap of planned     36
THERAPEUTIC
CREDITS: 1.0      RT fields.                                                                         Cisplatin 25 mg/m2 IV on Days 1, 8, 15, 22, 29, and
CANCER CONTROL                     not have had prior therapy that specifically and directly         36
CREDITS: 0.5      targets the EGFR pathway.
                                   not have had prior platinum-based or paclitaxel-based
                  therapy.
                                   not have prior allergic reaction to the drugs involved in this
                  study or prior severe infusion reaction to a monoclonal antibody.
                                   not have any of the following severe, active comorbidities:
                  Unstable angina or CHF requiring hospitalization within the past 3 months,
                  transmural MI within the last 6 months, acute bacterial or fungal infection
                  requiring IV antibiotics at time of registration, COPD exacerbation or other
                  respiratory illness requiring hospitalization or precluding study therapy at the
                  time of registration, or AIDS based on current CDC definition (HIV testing
                  not required for entry to study).
                                   not be pregnant or nursing. Women of childbearing potential
                  and male participants must practice adequate contraception.
                                                                                                                                                                             21

                                                                           HEAD AND NECK
         TITLE                                        ELIGIBILITY                                                            TREATMENT                             LOCATION
 E1305: A Phase III         Histologically or cytologically confirmed SCCHN, from any primary site          Arm A: Cisplatin plus Docetaxel OR Cisplatin          MBPCC
Randomized Trial of          that is either (a) recurrent, judged incurable by surgery or radiation or (b)   plus 5-FU.                                            LSUHSC
Chemotherapy with or         metastatic.                                                                     Vs.                                                   Veith
without Bevacizumab         No prior chemotherapy or biologic/molecular targeted therapy for                Arm B: Docetaxel plus Cisplatin plus                  MOL
in Patients with             recurrent or metastatic SCCHN.                                                  Bevacizumab OR Cisplatin plus Bevacizumab             MCLNO
Recurrent or                No prior bevacizumab, ECOG performance status of 0-1                            plus 5-FU.                                            CCS
Metastatic Head and         Previous palliative radiotherapy to the head and neck is allowed if a                                                                 EKL
Neck Cancer                  minimum of 8 weeks has elapsed between the end of prior radiotherapy
                             and entry into the protocol. No prior reirradiation in the head and neck
                             region is allowed. A minimum of 3 weeks must elapse between prior
                             radiation to other areas and study entry.
                            Must have recovered from the effects of any surgery, chemotherapy, or
                             radiation therapy, and should be > 4 weeks post surgery.
                            Patients must have measurable disease based on RECIST (see Sec.
                             6.0). Baseline measurements and evaluations of all sites of disease
                             must be obtained < 4 weeks prior to randomization. Disease in
                             previously irradiated sites is considered measurable if there has been
                             unequivocal disease progression or biopsy-proven residual carcinoma
                             following radiation therapy.
                            Persistent disease after radiotherapy must be biopsy proven at least 8
1 rx credit
                             weeks after completion of radiation therapy. (Radiographic findings are
                             acceptable providing that clear cut measurements can be made).
RTOG 0920: A PHASE              Histologically proven squamous cell carcinoma of the head/neck              Arm 1: Radiation Therapy                              EKL
III STUDY OF                     (oral cavity, oropharynx or larynx; hypopharynx primaries not               Radiation for a total dose of 60 Gy in 30 fractions   MBP
POSTOPERATIVE                    allowed). No simultaneous primaries or bilateral tumors.                    of 2 Gy/day                                           CCS
RADIATION THERAPY               clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant                                                                    MCLNO -
(IMRT) +/- CETUXIMAB             metastases ≤ 8 weeks of registration.                                       Arm 2: Radiation Therapy + Cetuximab                  pending
FOR LOCALLY-                                                                                                 Cetuximab initial dose of 400 mg/m2 IV x 1 dose
                                Patients must have had gross total resection of primary tumor with
ADVANCED                         curative intent ≤ 7 weeks prior to registration with surgical pathology
RESECTED HEAD AND                                                                                            Followed at least 5 days later by:
                                 demonstrating at least one of the following ―intermediate‖ risk factors:
NECK CANCER                                                                                                  Radiation for a total dose of 60 Gy in 30 fractions
                                 perineural invasion; lymphovascular invasion; single lymph node > 3
                                                                                                             of 2 Gy/day
                                 cm or ≥ 2 lymph nodes (all < 6 cm) [no extracapsular extension];
1 tx credit                      close margin(s) of resection, defined as cancer extending to within 5       Cetuximab 250 mg/m2 IV q week x 6 weeks
0.5      cc credit               mm of a surgical margin; T3 or microscopic T4a primary tumor; T2            concur-rently with RT.
                                 oral cavity cancer with > 5 mm depth of invasion.
                                                                                                             Followed by:
                                Patients must not have prior invasive malignancy (except non-               Cetuximab 250 mg/m2 IV q week x 4 weeks post–
                                 melanomatous skin cancer) unless disease free for ≥ 3 years.                RT.
                                Patients must not have positive margin(s) [defined as tumor present
                                 at the cut or inked edge of the tumor], nodal ex-tracapsular
                                 extension, and/or gross residual disease after surgery.
                                No prior chemotherapy or anti-EGF therapy, no allergy to cetuximab
                                Patients must not have had prior RT to the region of the study
                                 cancer that would result in overlap of RT fields.
                                Patients must not be eligible for RTOG 0619.
                                                                                                                                                                    22
IRB# 7604: ECOG          Histologically or cytologically confirmed squamous cell carcinoma of       Induction chemotherapy with Paclitaxel           MBP
                          the oropharynx as determined by H&E staining ,newly diagnosed                                                               Veith
E1308 A Phase II          disease,resectable disease OR disease that is expected to become           90mg/m2 on days 1,8, and 15, Cisplatin 75        MCLNO –
Trial of Induction        resectable after study treatment, stage III, IVA, or IVB disease as                                                         pending
                          determined by imaging studies (CT scan with IV contrast or MRI             mg/m2 on day 1, and Cetuximab loading dose       EKL-pending
Chemotherapy              required) and a complete head and neck exam
                                                                                                     of 400 mg/m2 on day 1, cycle 1 followed by
Followed by              Paraffin-embedded tumor specimen available for central confirmation
Cetuximab (Erbitux)       of HPV-associated disease as determined by H&E staining and in-            Cetuximab 250 mg/m2 on days 8 and 15 of
                          situ hybridization (ISH) for HPV-16 and IHC for p16, HPV-associated
with Low Dose vs.         disease is defined as p16 IHC-positive and/or HPV-16 ISH-positive          cycle 1 and days 1, 8, and 15 for all
Standard Dose            Measurable disease of the primary tumor or nodes by clinical and
                                                                                                     subsequent cycles. Doses will be
                          radiographic methods, defined as a lesion that is ≥ 2 cm in at least
IMRT in Patients          one dimension by clinical exam AND by radiographic exam with CT            administered based on actual body
with HPV-                 scan or MRI (or a lesion that is ≥ 1 cm in at least one dimension if the
                          radiographic exam utilizes spiral CT scan)                                 weight. Each cycle will be repeated every 21
Associated
                         No primary tumor or nodal metastasis fixed to the carotid artery, skull
Resectable                                                                                           days. A total of 3 cycles of this
                          base, or cervical spine
Squamous Cell            No evidence of distant metastases                                          combination will be administered.
                         No prior chemotherapy
Carcinoma of the         No prior radiotherapy above the clavicles
Oropharynx                                                                                           Low dose radiation: Cetuximab weekly
                         No prior surgery with curative intent for this disease (complete head
                          and neck exam with biopsy allowed)                                         plus 54.0 Gy/27 fractions IMRT
                         No prior therapy specifically and directly targeting the EGFR pathway      1. Clinical complete response in primary site.
1rx credit               ECOG performance status 0-1
                         Granulocytes ≥ 1,000/mm
                                                      3                                              VS.
                      
                                                         3
                          Platelet count ≥ 100,000/mm                                                Standard dose radiation: Cetuximab
                         Total serum bilirubin ≤ 1.5 mg/dL                                          weekly Plus 69.3 Gy/33 fractions IMRT.
                         Creatinine clearance ≥ 60 mL/min
                                                                                                     Patients with any of the following:
                         Not pregnant or nursing
                         Negative pregnancy test                                                    1. Clinical partial response or stable disease
                         Fertile patients must use effective contraception
                         No history of another malignancy (except for carcinoma in situ of the      in primary site
                          cervix and/or nonmelanomatous skin cancer) unless it has been              2. Grossly positive primary site tumor
                          curatively treated and the patient has been disease-free for ≥ 2 years
                         Patients with any of the following within the past 6 months are eligible
                          provided they have been evaluated by a cardiologist and/or
                          neurologist before study entry:
                               o NYHA class III-IV congestive heart failure
                               o Cerebrovascular accident or transient ischemic attack
                               o Unstable angina
                               o Myocardial infarction (with or without ST elevation)
                         No uncontrolled diabetes, uncontrolled infection despite antibiotics,
                          or uncontrolled hypertension within the past 30 days
                         No concurrent illness likely to interfere with study therapy or to
                          prevent surgical resection
                         No prior severe infusion reaction to a monoclonal antibody
                                                                                                                                                   23
                                                                          LEUKEMIA
        TITLE                                     ELIGIBILITY                                                   TREATMENT              LOCATION
NONE

                                                                                LUNG
          TITLE                                         ELIGIBILITY                                                TREATMENT            LOCATION
IRB# 5486: S9925, Lung      Patients must be enrolled on one of the following SWOG coordinated    Lung Cancer Specimen Repository   MBPCC
Cancer Specimen              lung cancer treatment protocols: SWOG-8805, SWOG-9019, SWOG-          Protocol, Ancillary               Veith
Repository Protocol,         9416, SWOG-9509, S9900, S0003, S0023, S0126, S0124, S0220,                                              MOL
Ancillary                    S0222, S0327, S0310, S0339, S0342, S0341, S0435, S0509, S0429,
                             S0533, S0526 or S0536. Patients subsequently found to be ineligible
Ancillary                    for the therapeutic protocol to which they are registered will be
0 rx credits                 declared ineligible for this protocol.
0 cc credits
                                                                                                                                                                               24
                                                                                         LUNG
         TITLE                                                  ELIGIBILITY                                                        TREATMENT                        LOCATION
IRB#6873C: RTOG                · Patients with histologically or cytologically proven diagnosis of Stage IIIA   Arms A and C:                                    MBPCC
(0617), NCCTG (N0628),          or Stage IIIB NSCLC within 12 weeks of registration.                             ·Arm C only: Cetuximab loading dose Week 1,      EKL
CALGB (30609): A               · Patients must be considered unresectable or inoperable.                        then ·                                           CCS
Randomized Phase III           · There must be no distant metastases.                                           Chemotherapy (given concurrently with XRT)       MCLNO
Comparison Of                  · Patients must have measurable or evaluable disease.                            · Arm C only: Cetuximab q week x 6 weeks
Standard- Dose (60 Gy)         · Patients must be at least 3 weeks from any prior thoracotomy.                  · Arms A and C: Paclitaxel +Carboplatin q
Versus High-Dose (74           · Patients must not have N3 supraclavicular disease.                             week x 6 weeks
                                                                                                                 ·Radiation Therapy (IMRT or 3DCRT)
Gy) Conformal                  · Patients must not have greater than minimal, exudative, or cytologically
                                                                                                                   ·2 Gy per fraction 5 days a week for 6 weeks
Radiotherapy With               positive pleural effusions (effusions must be proven non-malignant per
                                                                                                                 · Total dose = 60 Gy in 30 fractions
Concurrent And                  Section 3.1.4).
Consolidation                  · Patients must not have Pancoast tumors.
                                                                                                                 Arms B and D:
Carboplatin/Paclitaxel         · Patients must not have involved contralateral hilar nodes (i.e., greater       ·Arm D only: Cetuximab loading dose Week 1,
+/- Cetuximab (Ind              than 1.5 cm on short axis or positive on PET scan).                              then ·
#103444) In Patients           · Patients must not have ≥ 10% weight loss within the past month.                Chemotherapy (given concurrently with XRT)
With Stage IIIa/IIIb Non-      · Patients must not have had prior systemic chemotherapy for the study           · Arm D only: Cetuximab q week x 7 weeks
Small Cell Lung Cancer          cancer (prior chemo is allowed if for a different cancer).                       · Arms B and D: Paclitaxel +Carboplatin q
                               · Patients must not have had prior radiation to the region of the study          week x 7 weeks
                                cancer that would result in overlap of radiation therapy fields.                 ·Radiation Therapy (IMRT or 3DCRT)
                                                                                                                 · 2 Gy per fraction 5 days a week for 7.5
                                                                                                                 weeks
                                                                                                                 · Total dose = 74 Gy in 37 fractions

                                                                                                                 Following completion of combined therapy:
                                                                                                                 Consolidation chemotherapy:
                                                                                                                 ·Arm A: Paclitaxel and Carboplatin Days 64
                                                                                                                 and 85
                                                                                                                 ·Arm B: Paclitaxel and Carboplatin Days 71
                                                                                                                 and 92
                                                                                                                 ·Arm C: Paclitaxel and Carboplatin Days 71
                                                                                                                 and
                                                                                                                          92
                                                                                                                         Cetuximab Days 50, 57, 64, 71, 78, 85,
                                                                                                                         92, 99, 106
                                                                                                                 ·Arm D: Paclitaxel and Carboplatin Days 78
                                                                                                                 and
                                                                                                                         99
1 rx credit                                                                                                              Cetuximab Days 57, 64, 71, 78, 85, 92,
0.5 cc credit                                                                                                            99, 106, 113
                                                                                                                                                                           25
                                                                                     LUNG
          TITLE                                               ELIGIBILITY                                                       TREATMENT                       LOCATION
IRB#6937C: E1505: A            · Patients must have undergone complete resection of their NSCLC (stage       Arm A:                                         MBPCC
Phase III Randomized            IB [≥ 4 cm] - IIIA [T2-3N0, T1-3N1, T1-3N2]) prior to enrollment.             · Chemotherapy*                                Veith
Trial of Adjuvant              · Patients must have had lobectomy, sleeve lobectomy, bi-lobectomy, or        · 4 21-day cycles                              MOL
Chemotherapy With or            pneumonectomy.                                                                Arm B:                                         MCLNO
Without Bevacizumab            Mediastinal LN sampling must have been done at time of pre-operative          · Chemotherapy*                                CCS
for Patients With               mediastinoscopy or intraoperatively.                                          · Bevacizumab 15mg/kg IV Day 1 either before
Completely Resected            · Patients must be ≥ 6 weeks and ≤ 12 weeks post-thoracotomy.                 or after chemotherapy
Stage IB (> 4 cm) -IIIA        · Patients must not have received prior systemic chemotherapy at any time,    · 4 21-day cycles
Non-Small Cell Lung             or hormonal cancer therapy or radiation therapy as prior cancer treatment     · Bevacizumab will then continue for up to a
                                within 5 years of randomization.                                              total of one year (q 21 days)
Cancer (NSCLC)
                               · Patients must not have any history of CVA or TIA; no symptomatic or
                                uncontrolled CHF or cardiac arrhythmia.                                       *Chemotherapy Options—Must be chosen prior
                               · Patients with known history of MI or other evidence of thrombotic disease   to randomization
                                (angina) must have no evidence of active disease within at least 12 months    · Vinorelbine 30 mg/m2 IV Days 1 and 8
                                prior to randomization.                                                       Cisplatin 75 mg/m2 IV Day 1
                                                                                                              · Docetaxel 75 mg/m2 IV Day 1
                                                                                                              Cisplatin 75 mg/m2 IV Day 1
                                                                                                              · Gemcitabine 1200 mg/m2 IV Days 1 and 8
                                                                                                              Cisplatin 75 mg/m2 IV Day 1
                                                                                                              · Pemetrexed 500 mg/m2 IV Day 1
                                                                                                              Cisplatin 75 mg/m2 IV Day 1

                                                                                                              Bevacizumab is provided free of charge.

1 rx credit
CALGB 30607;                   histo or cyto stage IIIB/IV NSCLC                                             sunitinib or placebo                           MBPCC
Randomized, Phase III,         no brain mets, spinal compression, carcinomatous meningitis                                                                  Veith
Double-Blind Placebo-          no cavitary lesions                                                           sunitinib is free of charge                    MOL
Controlled Trial of            must have rec’d 4 cycles of platinum based doublet therapy w/ or w/o                                                         EKL
Sunitinib (NSC                  bevacizumab                                                                                                                  LKRMC
#736511, IND #74019)           no evidence of disease progression                                                                                           MCLNO
as Maintenance                 no prior adjuvant chemo for stage 1-III resected or combined modality                                                        CCS
Therapy in Non-                 therapy for stage III NSCLC
Progressing Patients           no other primary therapy for NSCLC
following an Initial Four      no CYP3A4 inhibitors or inducers (sect 4.16)
Cycles of Platinum-            must be able to swallow pills
Based Combination              some cardiac restrictions (section 4.7-9)
Chemotherapy in                no bleeding disorders
Advanced, Stage IIIB/IV
Non-Small Cell Lung
Cancer

1 rx credit
0.5 cc credit
                                                                                                                                                                   26
                                                                                       LUNG
         TITLE                                                ELIGIBILITY                                                      TREATMENT                LOCATION
IRB# 7297C: S0819, "A             Patients must have histologically or cytologically proven newly              Carboplatin/Paclitaxel or            MBPCC
Randomized, Phase III         diagnosed Stage IV, advanced primary non-small cell lung cancer                   Carboplatin/Paclitaxel/Bevacizumab   Veith
Study Comparing               (adenocarcinoma, large cell carcinoma, squamous or unspecified) or                                                     MOL
Carboplatin/Paclitaxel        recurrent disease after previous surgery and/or irradiation.                                                           CCS
or                                Patients with controlled (for a minimum of 2 months) brain metastases
Carboplatin/Paclitaxel/       after treatment,                                                                                                       Pending MCLNO
Bevacizumab with or               Patients may have measurable or non-measurable disease (see
without Concurrent            Section 10.1) documented by CT or MRI.
Cetuximab in Patients             Translational Medicine Studies: Patients must agree to submission of
with Advanced Non-            specimens for EGFR FISH testing and other translational medicine studies
Small Cell Lung Cancer        as outlined in Section 15.0. Patients must be offered participation in
(NSCLC)"                      banking for future research.
                                  Patients must not have received for any purpose prior chemotherapy,
                              cetuximab, gefitinib, erlotinib or other investigational agents that target the
                              EGFR pathway. Patients must not have received for any purpose prior
                              VEGF-related agents. Patients must not have received for any purpose
                              prior chimerized or murine monoclonal antibody therapy or have
                              documented presence of human anti-mouse antibodies (HAMA).
                                  Prior radiation is permitted; however, patients must have recovered
                              from all associated toxicities at time of registration.
                                  At least 28 days must have elapsed since surgery
                                  Zubrod Performance Status of 0 - 1 (




1 rx credit
                                                                                                                                                         27
                                                                                  LUNG
          TITLE                                          ELIGIBILITY                                                     TREATMENT            LOCATION
IRB# 7239: S0802, "A          Histologically or cytologically confirmed diagnosis of extensive stage                                      MBPCC
Randomized Phase II            small cell lung cancer (E-SCLC) with progression or recurrence after                                        Veith
Trial of Weekly                receiving exactly one standard first-line platinum-containing regimen.      Arm 1: AVE0005 plus topotecan   CCS
Topotecan with and             Measurable or non-measurable disease.                                                                       MCLNO
without AVE0005               Brain mets eligible only if has been treated and stable for at least 3      Arm 2: Single-agent topotecan   EKL
(Aflibercept; NSC-             months. No leptomeningeal involvement or brain stem mets.
724770) in Patients with      At least 21 days since prior RT.
Platinum Treated              At least 28 days since surgery.
Extensive Stage Small         No prior bevacizumab or other anti-angiogenic tx.
Cell Lung Cancer (E-          Zubrod PS 0-1.
SCLC)"                        No active infection or bleeding.
                              No uncontrolled hypertension.
                              No history of recent arterial embolic events or congestive heart failure.
                              No significant history of bleeding diathesis including hemoptysis or
                               underlying coagulopathy.
                              No prior history of encephalitis or encephalopathy. No diverticulitis, GI
                               bleeding, or peptic ulcer within prior 3 months.
                              Must be willing to provide smoking history.
                              No known AIDS or HIV-1.




1 rx credit
                                                                                                                                                                                    28
                                                                                          LUNG
        TITLE                                                ELIGIBILITY                                                                TREATMENT                           LOCATION
ECOG 5508                                                                                                            Induction Therapy—Step 1                            MBP
Randomized Phase III   predominant nonsquamous histology. There must not be small cell elements present.                                                                 Veith
                                                                                                                     Paclitaxel 200 mg/m2 IV on Day 1
Study of                                                                                                                                                                 EKL-pending
                       Patients with T4NX disease (stage IIIB) with nodule in ipsilateral lung lobe are eligible     Carboplatin AUC = 6 IV on Day 1                     MCLNO-pending
Maintenance Therapy
                       as long as they are not candidates for combined chemotherapy and radiation.                   Bevacizumab 15 mg/kg IV on Day 1
with Bevacizumab,                       not have had prior malignancy within the last three years except for
Pemetrexed, or a       superficial melanoma, basal cell carcinoma, or carcinoma in situ.                             Give four 21-day cycles
Combination of                          not have had prior systemic chemotherapy for advanced stage lung
Bevacizumab and        cancer.                                                                                       *Randomize patients eligible for Step 2*
Pemetrexed
                       since the prior chemotherapy administration.                                                  (Response of stable disease or better per
Following
                                                                                                                     RECIST plus other criteria listed in Section 3.2)
Carboplatin,
Paclitaxel and                          not have received prior paclitaxel, pemetrexed, or bevacizumab; prior        Maintenance Therapy—Step 2
                       carboplatin is allowed if given as part of adjuvant chemotherapy.                             Arm A:
Bevacizumab for                         be ≥ 18 years of age with ECOG PS of 0 or 1.
Advanced Non-                           not have brain metastasis.                                                   Bevacizumab 15 mg/kg IV on Day 1
Squamous NSCLC                          not have had major hemoptysis within four weeks prior to registration.       Give 21-day cycles until progression or
                                        not have uncontrolled intercurrent illness including, but not limited to,    unacceptable toxicity.
1rx credit             ongoing or active infection, symptomatic CHF, unstable angina pectoris, serious cardiac
                       arrhythmia, or psychiatric illness/social situations that would limit compliance with
                       study requirements.                                                                           Arm B:
                                                                                  ase as defined by RECIST           Pemetrexed 500 mg/m2 IV on Day 1
                       criteria (see Section 6.1.2).
                                                                                                                     Give 21-day cycles until progression or
                       appropriate anti-HTN therapy or diet.                                                         unacceptable toxicity.
                                         not have history of thrombotic events or major bleed within 12 months
                       prior to registration. They must not have had any major surgery, open biopsy or
                       significant traumatic injury within 3 months prior to registration, nor a core biopsy
                                                                                                                     Arm C:
                       within 7 days prior to registration.                                                          Pemetrexed 500 mg/m2 IV on Day 1
                                                              -coagulation.                                          Bevacizumab 15 mg/kg IV on Day 1
                                         not have significant vascular disease or history of abdominal fistula, GI
                       perforation, or intra-abdominal abscess within six months prior to registration.              Give 21-day cycles until progression or
                                         not have clinically significant cardiac disease.                            unacceptable toxicity.
                                         not have history of non-healing wounds, ulcers, or bone fractures.
                                         not have cavitary lesions in the lungs.
                                         not be pregnant or breast feeding; all fertile patients must agree to
                       abstain from sexual intercourse or use adequate contraception during study treatment
                       and ≥ 6 months after.
                                 Patients with HIV disease must not be taking anti-retroviral therapy.
                                                                                                                                                                                  29
                                                                                   LUNG
       TITLE                                              ELIGIBILITY                                                          TREATMENT                               LOCATION
                        · Patients with histologically or cytologically documented small cell lung          Arm A:                                                   MBPCC
                                                                                                                                                                     CCS
CALGB 30610 Phase III   cancer.                                                                             Cisplatin/Etoposide* x 4 21-day cycles
Comparison of           · Patients must have limited stage disease that is limited to one hemithorax with   Standard Radiation** (starts Day 1 of Cycle 1
                        regional lymph node metastasis, including ipsilateral hilar, ipsilateral and
Thoracic                                                                                                    or Cycle 2 of chemo)
                        contralateral mediastinal, and ipsilateral supraclavicular lymph nodes.
Radiotherapy            - Patients must not have disease involvement of the contralateral hilar or          45 Gy total dose divided into 1.5 Gy fractions
Regimens in Patients    supraclavicular lymph nodes, pleural effusions that are visible on plain chest      given BID over 3 weeks (total of 30 fractions)
with Limited Small      radiographs (whether cytologically positive or not), or cytologically positive
Cell Lung Cancer also   pleural or pericardial fluid (whether visible plain chest x-ray or not).            Arm B:
Receiving Cisplatin     · Patients must have measurable disease, which includes lesions that can be         Cisplatin/Etoposide* x 4 21-day cycles
and Etoposide           accurately
                        measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm      Radiation** (starts Day 1 of Cycle 1 or Cycle
                        with                                                                                2 of chemo)
                        conventional techniques or as ≥ 1 cm with spiral CT scan.                           70 Gy total dose divided into 2.0 Gy fractions
THERAPEUTIC             · Patients must not have received any prior radiotherapy or chemotherapy for        given once daily over 7 weeks (total of 35
CREDITS: 1.0            SCLC.                                                                               frac-tions)
CANCER CONTROL          · Patients must not have received any prior mediastinal or thoracic radiotherapy.
CREDITS: 0.5            · Patients must not have had complete surgical resection of disease.                Arm C:
                        · Patients must be ≥ 18 years of age; ECOG PS 0-2.
                                                                                                            Cisplatin/Etoposide* x 4 21-day cycles
                        · Patients must not be known to be pregnant or nursing.
                        The following are not exclusion criteria, but physicians should recognize that      Radiation** (starts Day 1 of Cycle 1 or Cycle
                        these                                                                               2 of chemo)
                        conditions may increase the risk to a patient entering the trial:                   61.2 Gy total dose divided into 1.8 Gy
                        · Psychiatric illness that would prevent the patient from giving informed           fractions given once daily for 16 days and then
                        consent.                                                                            BID for 9 days (total of 34 fractions over 5
                        · Medical conditions such as uncontrolled infection (including HIV),                weeks)
                        uncontrolled DM
                        or cardiac disease, which in the opinion of the treating physician would make
                        this                                                                                After the accrual of 30 patients per arm, there
                        protocol unreasonably hazardous for the patient.                                    will be an interim analysis. Either Arm B or
                        · Patients with “currently active” second malignancy other than non-melanoma        Arm C will be discontinued (based on toxicity)
                        skin                                                                                at that time and the study will continue with
                        cancers and carcinoma in situ of the cervix.                                        two arms.
                        · Women and men of reproductive potential should agree to use an appropriate        * Cisplatin 80 mg/m2 IV on Day 1 of each cycle
                        method                                                                              Etoposide 100 mg/m2 IV on Days 1-3 of each cycle
                        of birth control throughout their participation in this study. Appropriate          ** All radiation will be given 5 days a week (i.e., M-
                        methods
                                                                                                            F).
                        include abstinence, oral contraceptives, implantable hormonal contraceptives,
                        or
                        double barrier method.
                                                                                                                                            30

RTOG 0813              Does the patient have a pathologically (histologically or           Stereotactic body radiation therapy   Pending IGRT
Seamless Phase                                                                              (SBRT)                                approval for
                        cytologically) proven diagnosis of nonsmall cell lung cancer
I/II Study of                                                                                                                     MBPCC
                        (NSCLC)?
Stereotactic Lung
Radiotherapy           Is the patient AJCC stage T1-2, N0, M0, tumor size ≤ 5 cm,
(SBRT) for Early        prior to registration, based upon the minimum diagnostic
Stage, Centrally        workup specified in Section 3.1?
Located Non-
                       Was a history/physical examination performed within 4 weeks
Small Cell Lung
Cancer (NSCLC)          prior to registration?
in Medically           Was the patient evaluated by an experienced thoracic cancer
Inoperable              surgeon within 12 weeks prior to registration?
Patients               Was the pre-treatment imaging (CT scan with contrast; PET
                        using FDG) done within 8 week prior to registration?
                       Was the Zubrod performance status 0-2 within 4 weeks prior to
                        registration?
                       Is the tumor within or touching the zone of the proximal
                        bronchial tree (as defined in Section 3.1.5)? [Note: Tumors that
                        are immediately adjacent to mediastinal or pericardial pleura
                        (PTV touching the pleura) also are considered central tumors
                        and are eligible for this protocol.]
                       Does the patient have measurable disease?
                       Was pleural effusion absent, or, if present, was pleural effusion
                        deemed too small to tap under CT guidance and not evident on
                        chest x-ray? [Note: pleural effusion that appears on chest xray
                        will be permitted only after thoracotomy or other invasive
                        procedure(s).]
                       If female, was there a negative serum or urine pregnancy test
                        performed within 72 hours prior to registration for women of
                        childbearing potential?
                       If the patient is a woman of childbearing potential or a male
                                                                        31
    participant, did the patient agree to use a medically effective
    means of birth control throughout the patient’ s participation in
    the treatment phase of the study and until at least 60 days
    following the last study treatment?
   Did the patient provide study-specific informed consent prior to
    any protocol-specified procedure(s)?
   Has the patient had prior invasive malignancy within the past 2
    years (other than nonmelanomatous skin cancer) (e.g.,
    carcinomas in situ of the breast, oral cavity, or cervix are
    permissible)? [Note: previous lung cancer, if the patient is
    disease-free for a minimum of 2 years is also permitted.]
    The following questions must be answered NO.
   Has the patient received prior radiotherapy to the region of the
    study cancer that would result in overlap of radiation therapy
    fields?
   Does the patient plan to receive other local therapy (including
    standard fractionated radiotherapy and/or surgery) while on
    this study, except at disease progression?
   Does the patient plan to receive systemic therapy (including
    standard chemotherapy or biologic targeted agents) while on
    this study, except at disease progression?
                                                                                                                                                           32
                                                                            LYMPHOMA
          TITLE                                        ELIGIBILITY                                               TREATMENT                     LOCATION
IRB# 1576: S8947;                For patients registered to a currently active Southwest        Central Lymphoma Serum Repository Protocol   MBPCC
Central Lymphoma                  Oncology Group-coordinated treatment protocol for previously
Serum Repository                  untreated non-Hodgkin's lymphoma.
Protocol
ANCILLARY

0 rx credits
0 cc credits




                                                                      MULTIPLE MYELOMA
        TITLE                                           ELIGIBILITY                                                TREATMENT                    LOCATION
CALGB 70604: A       •    Histo confirmed adenocarcinoma of prostate or breast or multiple       zoledronic acid (every 12 weeks)             MBPCC
Randomized,          myeloma                                                                     versus                                       Veith
Phase III Study of       At least 1 bone mets confirmed by radiographic imaging                 zoledronic acid (every 4 weeks)              CCS
Standard Dosing          No prior IV bisphosphonate tx                                                                                       LSUHSC
versus Longer            No prior radiopharmaceuticals                                                                                       MOL
Dosing Interval          ≥ 4 week since completion of radio-therapy                                                                          MCLNO
of Zoledronic            No current investigational therapy
Acid in                  No brain mets
Metastatic               ECOG status of 0-2
Cancer

1 cc credit
                                                                                                                                                                                    33
                                                                            MULTIPLE MYELOMA
        TITLE                                              ELIGIBILITY                                                            TREATMENT                              LOCATION
S0777: A             · Patients with newly diagnosed multiple myeloma (MM) with measurable disease.           Arm 1 (LLD):                                             MBPCC
Randomized           Patients with non-secretory MM will be eligible only if the baseline serum Freelite      Dexamethasone 40 mg/day PO Days 1, 8, 15, 22             CCS
Phase III Trial of   is elevated.                                                                                                                                      Veith
                                                                                                              Lenalidomide 25 mg/day PO QD Days 1-21                   MCLNO
CC-5013              · Patients must have received no prior chemotherapy for this disease, nor any prior
(lenalidomide,       treatment with bortezomib or lenalidomide. They must not have received prior RT          Aspirin 325 mg/day PO QD continuously
NSD-703813) and      to a large area (more than half) of the pelvis. Prior steroid treatment is allowed as    Give six 28-day cycles
Low Dose             long as it was not longer than 2 weeks in duration.
Dexamethasone        · Patients must be ≥ 18 years of age with Zubrod PS of 0-3 (PS 3 allowed only if         Arm 2 (BLLD):
(LLD) versus         MM is the central cause of the disability).
                                                                                                              Dexamethasone 20 mg/day PO Days 1, 2, 4, 5, 8, 9,
Bortezomib (PS-      · Patients must be offered participation in the Myeloma Specimen Repository for
341, NSC-                                                                                                     11, 12
                     banking and future research (see Section 15.0 for more information).
681239),             · Sites must submit a local cytogenetics report and FISH analysis report obtained        Lenalidomide 25 mg/day PO QD Days 1-14
Lenalidomide         prior to enrollment on S0777.                                                            Bortozomib 1.3 mg/m2 IVP Days 1, 4, 8, 11
and Low Dose         · Patients with pathologic fractures, pneumonia at diagnosis or symptomatic
Dexamethasone                                                                                                 Aspirin 325 mg/day QD continuously
                     hyperviscosity must have these conditions attended to prior to registration.
(BLLD) for           · Patients must not have uncontrolled, active infection requiring IV antibiotics,        HSV prophylaxis per institutional standard
Induction, in        NYHA Class III or IV heart failure, MI within the last 6 months, history of              Give eight 21-day cycles
Patients with        treatment for clinically significant ventricular cardiac arrhythmias, poorly
Previously           controlled HTN, or poorly controlled DM.                                                 Note: Patients who intend to undergo transplant will
Untreated            · Patients must not have any psychiatric illness that could potentially interfere with
Multiple                                                                                                      undergo PBSC collection during either Arm 1 or
                     the completion of treatment according to the protocol.
Myeloma without                                                                                               Arm 2 treatment, preferably after the second cycle.
                     · Patients must not have a history of COPD or chronic respiratory pulmonary
an Intent for        disease.                                                                                 Maintenance Therapy with LLD:
Immediate            · Patients must not be Hepatitis B, Hepatitis C, or HIV positive (see Section 5.13       (begins after ≥ 4 cycles of LLD or ≥ 6 cycles of BLLD)
Autologous Stem      for exception related to treatment-sensitive HIV disease).                               Dexamethasone 40 mg/day PO Days 1, 8, 15, 22
Cell Transplant      · Patients must not have a history of CVA with persistent neurologic deficits.           Lenalidomide 25 mg/day PO QD Days 1-21
                     · Patients must be able to take ASA 325mg daily (or enoxaparin 40 mg SQ daily) as        Aspirin 325 mg/day PO QD continuously
THERAPEUTIC          prophylactic anticoagulation (unless already on anticoagulation).
CREDITS: 1.0
                     · Patients must not be pregnant. Those of both sexes must agree to follow the            Give 28-day cycles until progression
                     contraception requirements in Section 5.16 and undergo regular counseling about
                     avoiding pregnancy and having regular pregnancy tests (females).
                     · Patients must not have prior malignancy except for adequately treated BCC or
                     SCC of the skin, in situ cervical cancer, or other cancer for which the patient has
                     been diseasefree for five years.
                        · Patients must be offered participation in GEP molecular studies (see Section
                        15.2)
                                                                                                                                      34




                                                   PERFORMANCE STATUS SCALES

ZUBROD PERFORMANCE SCALE
0    Fully active, able to carry on all pre-disease activities without restriction.
1    Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example,
     light housework, office work.
2    Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3    Capable of only limited self-care, confined to bed or chair 50% or more of waking hours.
4    Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

KARNOFSKY PERFORMANCE SCALE
100  Normal; no complaints; no evidence of disease
90   Able to carry on normal activity; minor signs or symptoms of disease
80   Normal activity with effort; some sign or symptoms of disease
70   Cares for self; unable to carry on normal activity or do active work
60   Requires occasional assistance, but is able to care for most personal needs
50   Requires considerable assistance and frequent medical care
40   Disabled; requires special care and assistance
30   Severely disabled; hospitalization is indicated, although death not imminent
20   Very sick; hospitalization necessary; active support treatment is necessary
10   Moribund; fatal processes progressing rapidly
0    Dead

ECOG PERFORMANCE SCALE
0    Fully active, able to carry on all pre-disease performance without restriction
1    Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light
     house work, office work
2    Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3    Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4    Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5    Dead

								
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