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					                                                                                                                                                                                                                                         COMPREHENSIVE ACTIVE STUDY LIST
                                                                                                                                                                                                                                          BOOTH * ORANGE PARK * ST. VINCENT'S
                                                                                                                                                                                                                                                     Updated 6-111




If you are interested in any study, please refer to the below list for the appropriate contact.


Baptist Downtown- Med Onc               Gemma Sobretodo                                    904-739-7779


Baptist Downtown-Radiation              Jan Peer/Lois Morgan                   904-202-7027/202-7080

                                        Deborah Martinez                                               904-739-
Baptist South                           7779


Jacksonville Beach- Radiation           Jan Peer/Gemma Sobretodo                           904-202-7080


Orange Park                             Melissa Rammage                                     904-519-2731


Palatka                                 Melissa Rammage                                     904-519-2731


Jacksonville Beach                      Gemma Sobretodo                                    904-739-7779


Southside                               Deborah Martinez/ Gemma Sobretodo                    904-739-7779

                                        Deborah Martinez                                               904-739-
St. Augustine- Med Onc                  7779



St. Augustine- Radiation                Jan Peer                                             904-202-7027

St. Vincents                            Lynn Rosario / Katie Platt                           904-388-2619


BRAIN
       LINE             SPONSOR                                          STUDY                                           Site            PI        Status                                Abbreviated Eligibility
                                        RTOG 0913 - Phase I/II Trial of Concurrent RAD001 (Everolimus) with
                        RADIATION       Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in            All FROG        Michael        OPEN       Confirmed GBM by resection or open biopsy; Supratentorial and
      1st line          RTOG 0913       Newly Diagnosed Glioblastoma                                                  Locations       Olson         5-16-11     not recurrent or multifocal; Treatment starts < 5 weeks after surgery

BREAST
    LINE                SPONSOR                                          STUDY                                           Site            PI        Status                                Abbreviated Eligibility

                                                                                                                                                                Stage II or III Breast Cancer with a high risk of recurrence: Biopsy evidence of
                                                                                                                                                                breast cancer in regional lymph nodes (N+); Tumor size > 5 cm (T3) or locally
                          V-10-004                                                                                                                              advance disease (T4); must be receiving or scheduled to receive SOC adjuvant or
                           Amgen        Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3             OP, SS                                   neoadjuvant chemo and/or endocrine and/or HER-2 targeted therapy. Time
                        20060359 D-     Study of Denosumab as Adjuvant Treatment for Women with Early-Stage            & STV                         OPEN       between definitive surgery & randomization must be ≤ 8 wks. Time between start
     Adjuvant              CARE         Breast Cancer at High Risk of Recurrence (D-CARE) Accrual: 6 SF: 3              only          Sylvester     8-16-10     of neoadjuvant & randomization must be ≤ 4 wks.
                                        A Phase III Clinical Trial Comparing the Combination od TC +
                          TORI          Bevacizumab to TC Alone and to TAC for Women with Node Positive or
                       NSABP B-46-I     High Risk Node Negative, HER2 Negative Breast Cancer Accrual: 11                                            OPEN     Inclusion: Adenocarcinoma. – If FISH, CISH or other is equivocal,
     Adjuvant          TC TAC TOE       SF: 6                                                                          All Sites       Moezi        3-1-10   pt eligible as long as no plan to administer HER2-targeted therapy.
                                                                                                                                                             Female breast adenocarcinoma, locally recurrent or metastatic with 1
                                     A Phase 2, Multicenter, Single-Arm, Study of Single-Agent Eribulin                                                      measurable lesion ≥10mm longest diameter (non-LN) or ≥15mm short
                                     Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human                                                axis diameter (LN), no prior chemo/biologic/invest tx for
                           Eisai     Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer                                              OPEN    recurrent/metastatic disease (prior endocrine therapy is permitted),
   1st line (HER-)    E7389-A001-206 Accrual: 1                                                               All Sites                Dees        02-15-11 HER2 negative
                                                                                                                                                             Breast adenocarcinoma, locally recurrent or metastatic with 1
                                                                                                                                                             measurable lesion ≥10mm longest diameter (non-LN) or ≥15mm short
                                  A Phase 2, Multicenter, Single-Arm, Open-Label Study of Eribulin                                                           axis diameter (LN), 12 months since (neo)adjuvant tx, prior endocrine
                      V-10-008    Mesylate with Trastuzumab as First-Line Therapy for Locally Recurrent or                                                   therapy permitted, one prior treatment herceptin/lapatinib in metastatic
                        Eisai     Metastatic Human Epidermal Growth Factor Receptor Two Positive                                                     OPEN    setting permissible if not given with chemotherapy, Males or Females
1st Line    (HER+) E7389-A001-208 (HER2+) Breast Cancer                                                                All Sites       Dees         1-20-11  eligible
                                                                                                                                                             Adenocarcinoma of the breast (locally recurret or metastatic), no
                                     A Randomized Phase II Study of Imetelstat (GRN163L) in Combination                                                      prior therapy or one prior non-taxane regimen, no restrictions on
  1st or 2nd line        V-10-012    with Paclitaxel + Bevacizumab in Patients with Locally Recurrent or                                             OPEN    prior hormonal therapy, pts are excluded for prior adjuvant or
      (HER-)          Geron CP14B014 Metastatic Breast Cancer Accrual: 3                                               All Sites       Bubis      11-24-2010 neoadjuvant taxane tx w/in 12 months of 1st relapse
                                                                                                                                                                Central confirmation HER2+, prior treatment in adjuvant, locally
                                                                                                                                                                advanced/metastatic must include both a taxane + trastuzumab,
                                         A Randomized, Multicenter, Phase III Open-label Study of the Efficacy                                                  progression for locally advanced/MBC following most recent
                         Genentech      and Safety of Trastuzumab-MCC-DM1 vs. Capecitabine + Lapatinib in              OP, SS,                                  treatment or w/in 6 months after adjuvant tx, measurable or non-
   1st, 2nd line         TDM4370g       Patients with HER2-Positive Locally Advanced or Metastatic Breast             Baptist-all,                   OPEN       measurable disease, CNS only pts excluded, prior treatment with
     (HER+)               EMILIA        Cancer who have Received Prior Trastuzumab-Based Therapy Accrual: 1             STV            Moezi        3-28-11     lapatinib/capecitabine exclusionary

                                         An open-label, expanded access protocol of BSI-201 in combination with                                                 Histologically documented TNBC: prior tx includes never receiving
 2nd to 4th line       BiPar Sciences   gemcitabine/Carboplatin in patients with ER-, PR-, and HER2-negative                                        OPEN        chemo for metastatic breast ca or having rec’d 1-3 prior chemo
Expanded Access          2010EAP        metastatic breast cancer Accrual: 23 SF:2                                      All Sites        Naot        6-4-10      regimens in a metastatic setting.
                                                                                                                                                                ER+, progression on AI for MBC or recurrence within 1 yr on
                                         A Randomized Phase II Study of AFP464 +/- Faslodex in ER-positive                                                      adjuvant AI, only one prior chemo regimen for metastatic disease
                                        Breast Cancer Patients who had progressed on Aromatase Inhibitor (AI)                                                   allowed, confirmed AhR cytoplasm localization (central path),
                        USO 09056       therapy                                                                                                                 ECOG 0-2, measurable or evaluable disease (CA27.29≥≥50), Dlco
                          Tigris        **See USO 08118 (sub-study)                                                                                             grade 0-1, HER2+ pts are excluded unless they have progressed
                      Pharmaceuticals                                                                                                                OPEN       on both trastuzumab and lapatinib, symptomatic brain mets are
  Recurrent/ER+        TG-AFP-003                                                                                      All Sites       Moezi        4-26-11     exclusionary
                                        SUB-STUDY -Linked to USO 09056:
                                        Collection of Patient's Tumor Tissue for Analysis of Molecular Markers that                                  OPEN
 Tissue Specimen        USO 08118       Predict for Benefit from Cancer Therapies                                      All Sites       Moezi        4-26-11     Must be enrolled to USO 09056 Breast Protocol

COLON
       Line             SPONSOR                                          STUDY                                           Site            PI        Status                                Abbreviated Eligibility

                        Genentech       A Randomized Phase 2 Study of Bevacizumab/mFOLFOX6 vs.
                         ML25710        Bevacizumab/FOLFIRI With Biomarker Stratification In Patients With                                          OPEN
1st line Metastatic     MAVERICC        Previously Untreated Metastatic Colorectal Cancer                              All Sites     Badarinath     7-7-11
                                         A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan,
                                        Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-                                                                                                   st
                                        1121B) Drug Product of Placebo in Patients With Metastatic Colorectal                                                   Metastatic CRC, received FOLFOX+bev 1 line & progressed on tx or w/in
                            Lilly       Carcinoma Progressive Following First-Line Combination Therapy With                                          OPEN       6 mo last dose, measurable or non-measureable disease by RECIST, rec’d
                                                                                                                                                                                                      st
2nd line Metastatic    I4T-MC-JVBB      Bevacizumab, Oxaliplatin, and a Fluoropyrimidine                               All Sites     Badarinath     1-27-11     a minimum 2 doses of bevacizumab w/ 1 line tx
                                        Phase 1/2 study of PX-866 and cetuximab – To determine the maximum
                                        tolerated dose (MTD) or recommended Phase 2 dose (RD) of PX-866 to
                        Oncothyreon     be administered orally once per day in combination with cetuximab in                                                    metastatic CRC or SCCHN pts with measurable disease per
                        PX-866-003      patients with incurable metastatic colorectal carcinoma (CRC) or incurable                                              RECIST 1.1, progression after irinotecan and oxaliplatin for
                                        progressive, recurrent or metastatic squamous cell carcinoma of the head                                     OPEN       metastatic disease (or intolerance)-CRC pts. Exclusionary: pts with
3rd line Metastatic                     and neck (SCCHN). [phase 2 portion @ ICON]                                     All Sites     Badarinath     6-16-11     prior cetuximab or KRAS mutant codon 12/13
ENDROMETRIAL
       LINE             SPONSOR                                          STUDY                                           Site            PI         Status                               Abbreviated Eligibility




                                                                                                                                                                                                                                                                                1
                                                                                                                                                                                                                            COMPREHENSIVE ACTIVE STUDY LIST
                                                                                                                                                                                                                              BOOTH * ORANGE PARK * ST. VINCENT'S
                                                                                                                                                                                                                                         Updated 6-111




                                                                                                                                                         Hysterectomy & BSO for uterine cancer (< 56 days prior to study
                                                                                                                                                         entry. Must have Grade 3 w/ > 50% myometrial invasion, or Grade
                                           A Phase II study of postoperative IMRT with concurrent cisplatin and                                          2 or 3 w/cervical stromal invasion or Extra-uterine disease confined
                          RADIATION       bevacizumab followed by carboplatin and paclitaxel for patients with                                 OPEN      to pelvis. No (+) common iliac or para-aortic disease or (+)
     Adjuvant             RTOG 0921       endrometrial cancer                                                        All Sites    Johnson     4-23-10    peritoneal cytology. Performance 0-1.

HEAD AND NECK
         Line             SPONSOR                                          STUDY                                       Site         PI        Status                            Abbreviated Eligibility
                                                                                                                                                         Squamous - oral cavity, oropharynx or larynx - Clinical T2-3, N0-2,
                                                                                                                                                         M0 or T1, N1-2, M0; Gross total resect w/at least 1 risk factor -
                                                                                                                                                         perineural or lymphovascular invasion; 1 LN > 3cm or > 2 LN (all <
                                                                                                                                                         6 cm), close margins (within 5 mm), T3 or microscopic T4a, T2 oral
                          RADIATION       A Phase III Study of Post-operative Radiation Therapy (IMRT) +/-                                     OPEN      cavity with > 5 mm depth of invasion; Registered < 7 weeks from
     Adjuvant             RTOG 0920       Cetuximab for Locally Advanced Resected Head and Neck Cancer               All Sites    Johnson     7-16-10    surgery; PS 0-1

LUNG - SMALL CELL LUNG CANCER
    Line        SPONSOR                                                   STUDY                                        Site         PI        Status                            Abbreviated Eligibility

                         CALBG30610/      Phase III Comparison of Thoracic Radiotherapy Regimens with Limited        All FROG                  OPEN      Measurable disease (complete resection not eligible). No prior
      Limited             RTOG 0538       SCLC also Receiving Cisplatin and Etoposide Accrual: 4                     Locations    Johnson     6-19-08    chemo or XRT for SCLC or prior mediastinal/thoracic XRT. PS 0-2
                                          Randomized Phase II Study Comparing Prophylactic Cranial Irradiation                                           Extensive stage w/1-3 extra-cranial mets prior to platinum based
                                          Alone to Prophylactic Cranial Irradiation and Consolidated Extra-Cranial                                       chemo. No CNS mets; PR or CR to chemo in at least 1 site & no
                          RADIATION       Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)                                   OPEN      progression. Thoracic RT concurrently or prior to chemo eligible.
  Consolidation           RTOG 0937       Accrual: 1                                                                 All Sites    Johnson     7-16-10    Registered < 8 wks from completion of chemo


LUNG - NON-SMALL CELL LUNG CANCER
    LINE       SPONSOR                                                    STUDY                                        Site         PI        Status                            Abbreviated Eligibility
                                          A Randomized Phase III Comparison of Standard Dose (60 Gy) versus                                              Stage IIIA/B confirmed < 12 weeks from registration, unresectable
                                          High Dose (74 Gy) Confromal Radiotherapy with Concurrent and                                                   & measurable. No supraclavicular or contrahilar adenopathy. No wt
    First Line -          RADIATION       Consolidation Carboplatin/Paclitaxelo +/- Cetuximab in Patients with       All FROG                  OPEN      loss > 10% in past month, FEV1> 1.2 L/sec. No prior chemo for
   unresectable           RTOG 0617       Stage IIIA/IIIB Non Small Cell Lung Cancer Accrual: 13                     Locations    Johnson      3-4-08    study cancer. PS 0-1
                                                                                                                                                         Medically inoperable, T1 or T2 (< 5 cm), N0, M0; Central tumors
                                          Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for       BMC                               within or touching zones of proximal bronchial tree (volume of 2 cm
1st Line    Early         RADIATION       Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in      Downtown                  OPEN      around bronchial tree); No prior or planned XRT, chemo, surgery
  stage disease           RTOG 0813       Medically Inoperable Patients                                                Only       Johnson      7-8-10    for study cancer
                                          Randomized, Open-Label, Phase 3 Study of Premetrexed plus
                             V-10-015     Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in                                             Diagnosis of advanced NSCLC, non-squamous; No prior systemic chemotherapy,
                          Lilly H3E-US-   Patients with Advanced Non-Small Cell Lung Cancer of Nonsquamous                                     OPEN      immunotherapy; Prior RT is allowed to < 25% of the bone marrow; Measurable
1st line Metastatic            S130       Histology Accrual: 2                                                       All Sites     Bubis      11-8-10    disease; ECOG PS = 0, 1
                        SCRI LUN 201      Randomized Phase 3 Trial of Gemcitabine/Carboplatin with or without BSI-
     1st line           BiPar 20090321    201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously                                                Newly diagnosed, stage IV squamous NSCLC; prior adjuvant
    metastatic            (EFC11553)      Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)                                       OPEN      therapy OK if >12 months; previous RT is OK if recurrence outside
                           ECLIPSE        Accrual : 7 SF: 1                                                          All Sites     Bubis      7-13-10    original radiation site; ECOG of 0 or 1.
                                           A Randomized, Double-blind, Placebo-controlled Study to Evaluate the                                          Inclusion: Stage IV or stage IIIB malignant NSCLC; Receiving or
                                          Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500                                          about to receive 1st line cyclic chemo. Chemo-induced anemia
                                          mg Once-Every-3-Weeks (Q3W) to a Hemoglobin Ceiling of 12.0 g/dL in                                            defined as Hgb level < 11.0 g/dL at screening; Adequate
                            Amgen         Anemic Subjects with Advanced Stage Non-small Cell Lung Cancer                                       OPEN      screening serum folate (> 2 mg/mL) and vitamin B12 (>200
                           20070782       Receiving Multi-cycle Chemotherapy Accrual: 0 SF: 2                        All Sites   Badarinath   1-12-10    pg/mL).
                                                                                                                                                         Inclusion: Stage IIIb or IV; squamous histology allowed
                                                                                                                                                         (randomized to imetelstat alone arm); not amenable to radiation or
                                                                                                                                                         surgery with curative intent; patients should have completed 4
                                                                                                                                                         cycles of platinum based chemo doublet with no evidence of dx
                                                                                                                                                         progression; adjuvant chemo greater than one yr prior to
                                       A Randomized Phase II Study of Imetelstat as Maintenance Therapy after                                            progression is allowed. Pts will be excluded from being randomized
     Ist line              V-10-006    Initial Induction Chemotherapy for Advanced Non-Small Cell Lung Cancer                                  OPEN      if: * last dose of induction chemo < 21 days prior to randomization
   Maintenance          Geron CP14B012 (NSCLC)                                                                       All Sites     Bubis       6-8-10    or > 42 days prior to randomization
                                                                                                                                                         pts w/ progression on 1 prior platinum regimen (adjuvant or
                          USO 10061       A Randomized, Double-Blind, Phase 3 Study of Docetaxel and                                                     neoadjuvant platinum based tx with progression w/in 6 mo.), prior
                                          Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV                                OPEN      bev (1st line/maintenance) allowed, measurable disease by
2nd line Metastatic         Eli Lilly
                                          Non-Small Cell Lung Cancer Following Disease Progression after One                                  04-12-11   RECIST 1.1; exclusion for pts with more than 1 prior tx, pts with
                         I4T-MC-JVBA
                                          Prior Platinum-                                                                                                only prior erlotinib tx, pts on therapeutic anticoag (prophylactic low
                                          Based Therapy Accrual: 1 SF: 1                                             All Sites   Badarinath              dose allowed w/ INR criteria)

LYMPHOMA
    LINE                  SPONSOR                                         STUDY                                        Site         PI        Status                           Abbreviated Eligibility
                                                                                                                                                         DLBCL or DLBCL transformed from FL, bone core bx within 8wks
                                          A Randomized, Single-Blind, Multicenter Study Comparing Pixantrone +                                           randomization, received 1 but no more than 3 prior therapies,
                                          Rituximab with an Investigator’s Choice of Single Agent Rituximab or                                 OPEN      received RCHOP or equivalent previously w/ confirmed PR or CR,
                            V-10-027      Gemcitabine + Rituximab in Non-Stem Cell Transplant Eligible Patients                               04-28-11   at least 1 measureable (≥1.5cm short axis) nodal site (not previously
                        Cell Therapeutics with Aggressive B-cell Non-Hodgkins Lymphoma Who Have Relapsed                                                 irradiated), ECOG 0-2, LVEF≥45%; pts are excluded wtih CNS or
    Relapsed                 PIX 306      after Therapy with CHOP-R or an Equivalent Regimen Accrual: 0 SF: 1        All Sites     Moezi                 leptomeningeal lymphoma involvement
                                                                                                                                                         small lymphocytic, lymphoplasmacytic, marginal zone and follicular
                                                                                                                                                         lymphomas (GR 1,2,3a), CD20+ pathology, + response to
                                                                                                                                               OPEN      rituximab (PR/CR) lasting 6 mo from completion of tx, measurable
                                          Phase II Open-Label Study of Ofatumumab and Bendamustine Followed                                    6-6-11    disease [2 lesions ≥1.5cm LD or 1 lesion ≥ 2.0cm], ECOG 0-2
                            GSK           by Maintenance Ofatumumab for Indolent B-cell Non-Hodgkin’s                                                    Exclusionary: previous bendamustine, RIT w/in 6 months,
    Relapsed              OFB114612       Lymphoma (B-NHL) Which Has Relapsed after Rituximab Therapy                All Sites     Moezi                 previous allogeneic SC transplant, CNS involvement
                                                                                                                                                         Treatment naïve DLBCL pts subclassified as non-GCB (central
                                       An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness
                                                                                                                                               OPEN      path testing req'd), at least 1 measurable mass > 1.5cm long
                                       of RCHOP With or Without VELCADE in Previously Untreated Patients
                        DAVA Millenium with Non Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma                                     05-10-11   axis and >1.0cm short axis, ECOG < 2, LVEF>45%, pts
    Untreated              C05013                                                                                    All Sites     Moezi                 excluded for : CNS lymphoma, > grade 2 peripheral

MELANOMA
    LINE                  SPONSOR                                         STUDY                                        Site         PI        Status                           Abbreviated Eligibility
                                                                                                                                                         measurable disease (RECIST), no more than 1 prior systemic
                             ECOG         Trial of GM-CSF Protein Plus Ipilimumab in Patients with Advanced                                    OPEN      regimen for Stage III, IV melanoma (does not include adjuvant tx),
    st      nd
   1 or 2        line        E1608        Melanoma Accrual: 3                                                        All Sites   Sylvester     2-2-11    patients with CNS metastases are excluded, ECOG 0-1

MDS
         Line           Sponsor / CRO                                      STUDY                                       Site         PI        Status                           Abbreviated Eligibility
                                                                                                                                                         MDS confirmed w/in 6 weeks prior to entry (WHO/FAB
                                       A Phase III, Multi-Center, Randomized, Controlled Study to Assess the                                             classification), one cytopenia, progression OR failure to achieve
    Relapsed/
                                                                                                                                               OPEN      CR/PR OR relapse OR intolerance to azacitidine/decitabine w/in
    refractory/         Onconova 04-21 Efficacy and Safety of ON01910.Na Administered as a 72-hour
                                       Continuous Intravenous Infusion Every Other Week in Myelodysplastic                                     6-6-11    past 2 yrs, ECOG 0-2 Exclusionary: hyponatremia (<130mEq/L),
     intolerant
                                       Syndrome Patients with Excess Blasts Relapsing After, or Refractory to, or                                        ascites req paracentesis, HTN ≥160/110mmHg, prior low dose
                                       Intolerant to Azacitidine or Decitabine                                       All Sites     Moezi                 cytarabine w/in 2 yrs

MULTIPLE MYELOMA
    LINE      SPONSOR                                                     STUDY                                        Site         PI        Status                           Abbreviated Eligibility

                            Celgene                                                                                                            OPEN
                        Registry Protocol Connect ™ MM: The Multiple Myeloma Disease Registry Accrual: 7             All Sites     Moezi       3-1-10    Newly diagnosed with symptomatic MM.

PROSTATE
    LINE                  SPONSOR                                         STUDY                                        Site         PI        Status                            Abbreviated Eligibility

                                                                                                                                                         Rising PSA (> 0.1 - < 2.0 at least 6 wks from surgery);
                                          A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph                                         pT3N0/NXM0; or pT2N0/NXM0. Prostatectomy GS < 8, PS 0-1, no
                          RADIATION       Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer         All FROG                  OPEN      androgen deprevation for > 6 mos pre or any post prostatectomy.
                          RTOG 0534       Patients With a Rising PSA After Radical Prostatectomy                     Locations    Johnson      4-3-08    No prior pelvic RT.

                                          A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-
                          RADIATION       CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate All FROG                    OPEN      T2-4, NO-1, MO - Post-op PSA within 4 weeks of registration: PSA
                          RTOG 0622       Cancer After Radical Prostatectomy                                       Locations      Johnson     12-11-08   > 2.0 ng/ml; or - PSA > 0.2 if GS 9 or 10.




                                                                                                                                                                                                                                                                    2
                                                                                                                                                                                                                          COMPREHENSIVE ACTIVE STUDY LIST
                                                                                                                                                                                                                           BOOTH * ORANGE PARK * ST. VINCENT'S
                                                                                                                                                                                                                                      Updated 6-111




                                     A Randomized, Double-Blinded, Placebo-Controlled Phase III Trial to                                              T1b-T2b adenocarcinoma; (-) LN by imaging, nodal sampling or
                                     Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in                             OPEN    dissection; No bone mets; PSA - GS < 7 & PSA < 20 ng/ml or GS
                     RADIATION       Prevention of Erectile Dysfunction in Patients Treated with Radiotherapy       All FROG                  1-8-10  > 7 & PSA < 15 ng/ml; Some degree of pre-cancer tx erectile
                     RTOG 0831       for Prostate Cancer                                                            Locations   Johnson     Temp HOLD function; PS = 0-1

RENAL
     LINE            SPONSOR                                          STUDY                                           Site         PI         Status                          Abbreviated Eligibility
                                     Randomized Phase III Trial Comparing Everolimus Plus Placebo versus                                                 Prior tx with 1 VEGFR TKI, no prior systemic tx with bev, no prior tx
     2nd line          ECOG
                    CALGB 90802      Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma                                             OPEN      with mTOR (temsirolimus, everolimus), tx washout 4 weeks,
   (after TKIs)
                                     Progressing After Treatment with Tyrosine Kinase Inhibitors                    All Sites   Sylvester     3-15-11    measurable disease by RECIST, no active brain mets


SOLID TUMORS
      LINE           SPONSOR                                          STUDY                                           Site         PI         Status                           Abbreviated Eligibility
                                                                                                                                                       NSCLC: no more than 2 prior tx, at least 1 prior platinum regimen
                                                                                                                                                       w/ taxane; Prostate: no more than 2 prior txs, prior regimen with
                        V-10-007
                                     A phase 2 Indication Identification Study of LY2523355 in Patients with                                           docetaxel; Colorectal: at least 2 no more than 3 prior cytotoxic txs;
                     Lilly I1Y-MC-
                                     Ovarian, Non-Small Cell Lung, Prostate, Colorectal Gastroesophageal                                       OPEN    GE: no more than 2 prior txs; SCCN: no more than 2 prior txs;
                          JFBF
 2nd or 3rd line                     Cancers, and Sqamous Cell Carcinoma of the Head and Neck Accrual:                                      04-01-2011 Measurable disease per RECIST 1.1 required (except for prostate
   Metastatic                        5                                                                              All Sites    Dees          HOLD    pts); ECOG 0-1
                                     A Randomized, Blinded, Placebo-controlled, Two-Phase, Sequential                                                  Inclusion: Pts to receive P2 cycles with gemcitabine (monotx or
                                     Cohort, Dose Finding Study to Assess the Safety and Efficacy of an Oral                                           with carbo/cisplatin).[bevacixumab/er;otinib require GSK approval].
                                     Thrombopoietin Receptor Agonist, Eltrombopag (SB-497115-GR),                                                      Pre-chemo PLTs < 300 and >100 on C1, D1. Exclusion: CV hx
                                     Administered to Patients with Solid Tumors Receiving Gemcitabine                                                  (CHF grade III/IV, A Fib, unstable angina. FVL, APS, Protein C/S
                        GSK          monotherapy or Gemcitabine Plus Carboplatin or Cisplatin Chemotherapy                                     OPEN    deficiemcies. DVT, PE or MI within 6 months. RT requires 4 wk
    PHASE I          TRC112765       Accrual: 0 SF: 1                                                               OP only      Moezi        8-16-10  washout

SUPPORTIVE CARE
      Line         Sponsor / CRO                                      STUDY                                           Site         PI         Status                          Abbreviated Eligibility
                                                                                                                                                         Colorectal, NSCLC or SCLC pts, metastatic or locally advanced,
                      V-11-005                                                                                                                           starting new chemotherapy (new line of therapy included), pts on
                   DIREG_C_04823                                                                                                                         non blinded clinical trials are eligible; Exclusionary: anticoagulant
                     CANTARISK   A prospective, non-interventional, cohort survey on VTE risk in patients                                     OPEN       use (exception is central venous catheter patency), life
 Supportive Care                 receiving new chemotherapy for cancer                                              All Sites    Bubis       06-29-11    expectancy<4 months

UNKNOWN PRIMARY
      LINE           SPONSOR                                          STUDY                                           Site         PI         Status                           Abbreviated Eligibility
                                                                                                                                                         Must have biopsy material available from a surgical biopsy or a core
                                                                                                                                                         needle biopsy; must have adequate path specimen for molecular
                                     A Phase II Study of Chemotherapy Treatment Based on Molecular                                                       profiling; measurable or evaluable disease; patients with brain
                       SCRI          Profiling Diagnosis for Patients with Carcinoma of Unknown Primary Site                                  OPEN       metastases ok if all lesions have been controlled by resection or
                     UNKPRI 20       Accrual: 9 SF: 4                                                               All Sites   Sylvester    11-12-08    radiation therapy (RT) not steriod-dependent.




                                                                                                                                                                                                                                                                 3
                                                                                                                                                                             COMPREHENSIVE PENDING NEW STUDY LIST
                                                                                                                                                                                         Updated 5-10-11




  BREAST
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status
                                       A Randomized, Phase 2 Trial of Preoperative MM-121 with Paclitaxel in HER2-
                   USO 10167 MerriMack                                                                                                                  on hold due to sponsor
                                       negative Breast Cancer
  Neoadjuvant        Pharmaceuticals                                                                                                          Bubis      training requirements
                                       A randomized multicenter, double-blind, placebo-controlled comparison of
                    Roche BIG-04-11 / chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab
                   BO25126 Genentech plus pertuzumab as adjuvant therapy in patients with operable HER2- positive primary
   Adjuvant            TOC4939G        breast cancer                                                                                          Bubis         SQV 6/7/2011
                                          A Phase III Randomized, Multicenter, Two-Arm, Open-Label Trial to Evaluate the
                                          Efficacy of T-DM1 Compared with Treatment of Physician's Choice in Patients with
 2nd or 3rd line        Genentech         HER2-Positive Metastatic Breast Cancer Who Have Received At                             3 main                       waiting
   metastatic           TDM4997g          Least Two Prior Regimens of HER2-Directed Therapy                                        sites      Moezi        contract/budget

LUNG
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status
                                                                                                                                                         Approved Nov 2010;
                                          A randomized, phase III, multi-center, double blind, placebo-controlled study
                                                                                                                                                          FPI estimated Fall
 2nd & 3rd line         Genentech         evaluating the safety and efficacy of MetMAb, a monovalent antibody antagonist to the
                                                                                                                                                         2011; site selection
   Metastatic           OAM4971g          Met receptor, in combination with Tarceva® (erlotinib) in patients with Met high
                                                                                                                                                          process underway;
                                          incurable stage IIIB/IV non-small cell lung cancer (NSCLC) who have failed standard
                                                                                                                                                             SQV 6-20-11
                                          therapy for advanced or metastatic disease                                                          Bubis

     SCLC -                               Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of
                     BristolMyerSquibb    Ipilimumab Plus Etoposide/Platinum versus Placebo plus Etoposide/Platinum in
Treatment Naïve;                                                                                                                                         Approved June 2011
                         CA184-156        Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED
 Extensive stage
                                          SCLC)

MDS
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status

   Thrombo-              GSK              A three-part Study of Eltrombopag in Thrombocytopenic Subjects with                                            Pending contract &
   cytopenia           TRC114968          Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, Part 2:                                    budget
                                          randomized, double-blind, placebo-controlled, Part 3: open-label extension).                        Moezi

MELANOMA
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status

                       Morphotek          A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in
 2nd or 3rd line                                                                                                                                         Approved Mar 2011
                      004-201-Mel         Subjects with Metastatic Melanoma


MULTIPLE MYELOMA
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status
                                          A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or
                    BristolMyers Squibb
                                          Without Elotuzumab in Ist Line Multiple Myeloma
                         CA204006
    1st line                                                                                                                                  Moezi            SIV 7/18

PANCREATIC
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status

                      Pharmacyclics       Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer
    1st line           PCYC-1001          Patients Receiving Treatment with Gemcitabine                                                                  Need potential patient
   Metastatic                                                                                                                                 Moezi     to complete Regulatory

                                        A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared
                   V-10-025     Elieson
                                        with Fluorouracil (5-FU) in Patients with Metastatic Pancreatic Adenocarcinoma
    2nd line            EP-GF-301                                                                                                                         Per veeda pushed
                                        Previously Treated with Gemcitabine
   Metastatic                                                                                                                                 Moezi       back to June/July

                       US Oncology        A Randomized Phase III Study of Weekly ABI-007 plus Gemcitabine versus
                                                                                                                                                         Approved May 2011
    1st line             05129            Gemcitabine Alone in Patients with Metastatic Adenocarcinoma of the Pancreas.
   Metastatic

PROSTATE
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status
                                          Randomized, Open Label Multi-Center Study comparing cabazitaxel at 25 mg/m2 and                                  Contract/Budget:
                       SanofiAventis      at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in                                         pending, Bubis;
                        EFC11784          Combination with Prednisone in Patients with Hormone Refractory Metastatic Prostate                 Dees      Dees/IRB approved SIV
    1st line                              Cancer not Pretreated with Chemotherapy                                                             Bubis              6-28

                                          Randomized, Open Label Multi-Center Study comparing cabazitaxel at 20 mg/m2 and                                  Contract/Budget:
                       SanofiAventis      at 25 mg/m² in Combination with Prednisone Every 3 Weeks to the Treatment of                                     pending, Bubis;
                        EFC11785          Hormone Refractory Metastatic Prostate Cancer Treated with a Docetaxel-Containing                   Dees      Dees/IRB approved SIV
    2nd line                              Regimen                                                                                             Bubis              6-28


SUPPORTIVE CARE
     Line           Sponsor / CRO                                               STUDY                                             Site         PI              Status
                                                                                                                                                        SQV completed 4/11/11;
                     Merck-V212-011       A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and                            Site selected; regulatory
Supportive Care                           Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy                    Badarinath            started




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