Revised 1/6/2011 OPEN TRIALS 2006-2011 INDICATION Number ENROLLED SPONSOR Title Provided Phase I AZA PH US 2007 PK 006 Celgene A Phase I, Open-Label, Multi-Center, Parallel Group Study to Assess the Pharmacokinetics and Safety of Subcutaneous Azacitidine in Adult Cancer Patients With and Without Impaired Renal Function Azacitidine Sterling Main Only 9/1/2010 Maureen Phase I NSCLC ISIS 183750- CS4 ISIS Pharmaceuticals A Phase1b/2 Study of Carboplatin- Paclitaxel, With or Without ISIS 183750, in Patients with Stage IV NSCLC ISIS 183750 Carboplatin Paclitaxel Goodwyn Main Only 11/22/2010 Maureen Phase I NSCLC U31287-A- U201 Daiichi Sankyo Randomized, Placebo-Controlled, Double- Blind Phase 1b/2 Study of U3-1287 in Combination with Erlotinib in EGFR Treatment Naïve Subjects with Advanced NSCLC Who Have Progressed on at Least One Prior Chemotherapy U3-1287 Erlotinib Pending SIV Quorum JOHA Main Only Review 11/30/2010 Maureen First Line NSCLC Stage IV H3E-US- S130 1 Lilly Randomized, Open-Label, Phase III Study of Pemetrexed plus Carboplatin Followed by Maintenance Pemetrexed versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Advanced NSCLC of Nonsquamous Histology Pemetrexed Paclitaxel, Carboplatin, Bevacizumab Schulman Associates West, East & 9/17/2009 Morris Maureen First-line NSCLC CP15-0804 ImClone A Randomized Phase II Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC- 3G3) with Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Previously Untreated Patients with Locally Advanced or NSCLC IMC-3G3 Carboplatin Paclitaxel W 8/4/2010 Maureen First-line NSCLC AC01L08 20 ACORN Observational NSCLC VIEW 4 Biodesix, Inc. Hepatocellular C80802 ECOG/ A Multi-center Randomized Phase 2b Study of Cetuximab in Combination with Platinum-Based Chemotherapy as First Line Treatment of Patients with Recurrent or Advanced NSCLC Cetuximab W West, East, Morris, Flossmoor 1/15/2009 Maureen VeriStrat Observational Study of Patients with NSCLC NE 9/22/2010 Maureen Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Sorafenib or Sunitinib or Placebo Doxorubicin Cross 8/5/2010 Karen
SPONSOR Title Provided Colon ECOG E5202 ECOG A Randomized Phase III Study Comparing FOLFOX vs. FOLFOX and Bevacizumab in Patinets with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers Oxaliplatin Bevacizumab 5-FU, Leucovorin HOLD all sites Cross 5/6/2010 Karen Untreated Colorectal C80405 14 ECOG/ A Phase III Study of FOLFIRI or FOLFOX with Bevacizumab, or Cetuximab or with the combination of Bevacizumab and Cetuximab for Patients with Untreated Adenocarcinoma of the Colon or Rectum FOLFIRI FOLFOX, Bevacizumab, Cetuximab Cross 3/10/2008 Karen Prostate ECOG E3805 1 ECOG ChemoHormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer Docetaxel LHRH agonists, Antiandrogens Cross 11/6/2008 Maureen Genentech / TDM4370g 3 Roche A Randomized, Multicenter, Phase III Open Label Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs Capecitabine + Lapatinib in Patients with HER2+ Locally Advanced or Cancer who have Received Prior Trastuzumab based therapy Trastuzumab-MMC- DM1 Capecitabine Lapatinib Quorum Main and Morris 1/23/2009 only Karen C40502 ECOG/ A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab- Paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Cancer Bevacizumab, Nab- Paclitaxel, Ixabepilone Paclitaxel Cross 3/11/2010 Karen LPT112515 GSK A Randomized, Phase III, Open-Label, Study of Lapatinib plus Trastuzumab versus Trastuzumab as Continued HER2 Suppression Therapy after Completion of First - or Second-line Trastuzumab plus Chemotherapy in Subjects with HER2- positive Cancer Lapatinib Trastuzumab Quorum Open - West, East & Morris 5/28/2010 Madelyn
SPONSOR Title Provided ECOG E5103 2 ECOG A Double-blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patinets with Lymph Node Positive and High risk Lymph Node Negative Cancer Bevacizumab Doxorubicin, Cyclophosphamide, Paclitaxel Cross 2/5/2009 Karen Neoadjuvant C40601 ECOG/ Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib, or Both as Neoadjuvant Treatment of HER2- Positive Primary Cancer Lapatinib Paclitaxel, Trastuzumab Cross 7/1/2010 Madelyn Cervical GOG 0240 1 ECOG/ A Randomized Phase III Trial of Cisplatin Plus Paclitaxel with and without NCI- Supplied Bevacizumab versus the Non- Platinum Doublet, Topotecan plus Paclitaxel, with and without NCI-Supplied Bevacizumab in Stage IVB Recurrent or Persistent Carcinoma of the Cervix Bevacizumab Paclitaxel, Cisplatin or Topotecan Cross 11/5/2009 Karen Multiple Myeloma Registry Connect 1 Celgene DLBCL PI-08904 1 Pharmatech / Cephalon Connect The Multiple Myeloma Disease Registry Quorum 10/19/2009 Open Madelyn Bendamustine Combined with Rituximab for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphona Bendamustine Rutuximab COMPASS West, East, Morris, Flossmoor Maureen Chemotherapy Induced Peripheral Neuropathy (oxaliplatin or paclitaxel) C170601 ECOG/ A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated with Chemotherapy-Induced Peripheral Neuropathy Duloxetine Cross 3/11/2010 Madelyn Prosatate,, Multiple Myeloma C70604 2 ECOG/ A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Cancer Cross 9/3/2009 Madelyn STOP TRIALS LISTED BELOW CLOSED TO NEW PATIENT ACCRUAL
INDICATION Number ENROLLED SPONSOR Title Provided CLOSED STUDIES NHL Lympho Care U2963n 7 PPD 4 Genentech No additional An Observational Study of Treatment Outcomes and Prognosis in Patients with Follicular non-hodgkin's Lymphoma No Coast patients to go on study met our 3/5/2004 quota BREAST EGF105485 3 GSK TEACH Study: A Randomized, Doubleblind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib in Women with Early-Stage ErbB2 Overexpressing Cancer Lapatinib (Tykerb) Copernicus 9/1/2006 Closed EGF104383 3 GSK A Randomized, Double Blind, Placebo- Controlled, Multicenter, Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women with ErbB2 Overexpressing Cancer Lapatinib (Tykerb) Trastuzumab & Paclitaxel Copernicus 11/14/2006 Closed Karen Observational Study of Avastin AVF3991n 11 Genentech An Observational Study of Avastin (Bevacizumab) In Combination With Chemotherapy For Treatment of or Locally Advanced and Unresectable Colorectal Cancer, and Locally Advanced or NSCLC (Excluding Closed All Sites Predominant Squamous Cell Histology) Avastin NE 1/2/2007 Enrolling Jenn NSCLC NO21160 1 Roche A Randomized, Double-blind Study to Determine the effect of Two Dose Schedules of R1507 or Placebo, Both in Combination with Erlotinib, on Progression- Free Survival in Patients with Advanced NSCLC with Disease Progression After Closed all sites First or Second Line Chemotherapy R1507 & Erlotinib Quorum 9/8/2008 Maureen
SPONSOR Title Provided Epithelial, Ovarian or Primary Peritoneal GOG- 0218 3 GOG A Phase III Trial of Carboplatin and Paclitaxel plus Placebo verses Carboplatin and Paclitaxel plus Concurrent Bevacizumab Followed by Placebo, versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in women with newly Diagnosed, Previously Untreated, Stage III or IV, Epithelial Bevacizumab / Ovarian or Primary Peritoneal Cancer Placebo Carboplatin Paclitaxel Cross 2/7/2008 Closed Karen Relasped or Refractory Follicular Non- Hodgkin's Lymphoma 114-NH-301 Biogen Idec A Phase III Randomized Double Blind Study of Galiximab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory Galiximab Follicular Non-Hodgkin's Lymphoma Rituximab Chesapeake Research Review, Inc. closed Michelle Colon N0147 7 Phase III Trial of FOLFOX with or without Cetuximab after Curative Resection for Patients with Stage III Colon Cancer Oxaliplatin Cetuximab 5-Fluorouracil Leucovorin Permanently closed Cross 9/18/2008 11/25/2009 SCLC AMRPHGL2 007CL001 4 2 S/F Celgene A Randomized Open-Label Multinational Phase III Trial comparing Amrubicin vs Topotecan in patients with Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy Amrubicin Topotecan W Closed Main, East, Morris 3/6/2008 Maureen Adjuvant S0307 3-SF 20 SWOG Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Cancer Zoledronic Acid or Clodronate or Ibandronate closed all sites Cross 12/4/2008 Karen
SPONSOR Title Provided NSCLC OSI-774-302 2-SF 2 OSI Pharmaceuticals A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study of Single-agent Tarceva (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA NSCLC who have EGFRpositive Tumors Tarceva W Closed All sites Enrolling 8/30/2006 Maureen Second line Colon KRAS Mutant 20060579 0 Amgen A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 vs FOLFIRI for the Second-line Treatment of KRAS-mutant Colorectal Carcinoma Closed Karen AMG 479 / AmG 655 FOLFIRI W Main & Morris 1/19/2009 only Adjuvant S0221 1- SF 5 SWOG A Phase III Trial of Continuous Schedule AC+G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post- Operative Adjuvant Therapy in Node- Positive or High-Risk Node-Negative Cancer Cyclophosphamide Doxorubicin Filgrastim Pegfilgrastim Paclitaxel Bactrim Closed all sites Cross 6/5/2008 Karen Multiple Myeloma CZOL446E US129 0 Novartis Bone Marker Directed Dosing of Zometa for the Prevention of Skeletal Complications in Patients with Advanced Multiple Myeloma Zometa Copernicus 6/18/2008 Closed Michelle DLBCL / Follicular non- Hodgkin's Lymphoma U4391g 10 Genentech Phase III Multicenter, Open-Label Study of Rituximab Faster Infusion Time in Patinets with Previously Untreated Diffuse Large B- Cell or Follicular Non-Hodgkin's Lymphoma Rituximab Study on Hold JOHA Main, ES Quorum & Morris only Review 2/20/2009 Maureen Multiple Millennium Myeloma C05009 6 Pharmaceuticals Randomized Phase 3b Study of 3 Treatment Regimens in Subjects with Previously Untreated Multiple Myeloma who are not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: Velcade, Thalidomide, and Dexamethasone vs Velcade and Dexamethasone vs Velcade Melphalan and Prednisone Velcade Thalidomide Melphalan Prednisone Dexamethasone Copernicus 11/2/2007 Closed Maureen
SPONSOR Title Provided NSCLC PGT307 2 on 1 withdrew consent Cell Therapeutics Paclitaxel Poliglumex (CT- 2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Paclitaxel Advanced Non-Small Cell Lung Cancer in Poliglumex (CT- Women with Estradiol >25 pg/ml 2103) Paclitaxel Carboplatin Chesapeake Research Review, Inc. 7/3/2007 Closed Maureen Prostate / SWOG S0421 1-SF / Phase III Study of Docetaxel and Atrasentan vs Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer Atrasentan Docetaxel Closed all Sites Cross 2/5/2009 Michelle Relapsed Follicular Lymphoma C05012 Millennium 1 Pharmaceuticals A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (bortezomib) in Combination with Rituximab, Cyclophosphamide, and Prednisone with or without Doxorubicin followed by Rituximab Maintenance in Patients with Relapsed Follicular Lymphoma COMPASS Closed Maureen 3160A-2206- WW 2-SF 2 Wyeth A Phase II, Randomized, Open-label Study of Bosutinib Administered in Combination with Exemestane vs. Exemestane Alone as Second Line Therapy in Post- Menopausal Women with Locally Advanced or ER+/PgR+/ErbB2- Cancer Bosutinib Exemestane COMPASS 2/17/2009 HOLD Madelyn 3160A6-2207-WW 1 Wyeth A Phase II Randomized, Open-Label Study of Bosutinib Administered in Combination with Letrozole vs Letrozole Alone as First Line Therapy in Post-Menopausal Women with Locally Advanced or ER+/PgR+/erbB2- Cancer Bosutinib, Letrozole W 3/11/2009 Hold Madelyn Ovarian ImClone CP15-0802 2 ImClone A Randomized Phase II Trial Investigating Liposomal Doxorubicin with or without Anti- Platelet Derived Growth Factor Receptor Alpha Monoclonal Antibody IMC - 3G3 in Patients with Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer IMC - 3G3 Liposomal Doxorubicin Chesapeake Research Review, Inc. Closed Main, ES, Morris only Karen
SPONSOR Title Provided Renal Cell E2805 7 ASSURE Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma Sorafenib or Sunitinib or Placebo Closed all sites Cross 4/3/2008 Karen Adjuvant PACCT- 1/TAILORx 6 1 screen fail /ECOG Program for the Assessment of Clinical Cancer Tests. Trial Assigning Individualized Options for Treatment TAILORx trial Cross 7/3/2008 Closed Karen Non-Germinal Center B-Celllike DLBCL C05013 Millennium 0 Pharmaceuticals An Open-Label, Randomized, Phase II Study to Assess the Effectiveness of RCHOP With or Without Velcade in Previously Untreated Patients with Non- Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Velcade RCHOP Copernicus 6/26/2009 Closed Maureen Second-line Bladder, Renal Pelvis,Ureters Stage III, IV 1230.2 Boehringer 1 Ingelheim An Open-Label, Single-Arm, Phase II Trial of Intravenous BI 6727 in Patients With Locally Advanced, or Recurrent Urothelial Cancer of the Bladder, Renal Pelvis, or Ureters After Failure of Prior Chemotherapy BI 6727 Schulman Closed JOHA Associates West, East, & 11/18/2009 Morris Karen Follicular non- Hodgkin's Lymphoma PCYC-0403 Pharmacyclics, Inc. Phase I/II Dose-Escalation Study of the Pan-Histone Deacetylase (HDAC) Inhibitor PCI-24781 in Lymphoma PCI-24781 Pending identification of potential patient Maureen NSCLC EMR 63325-001 2 Merck KGaA A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects with Unresectable Stage III Disease BLP25 & Cyclophosphamide Quorum 12/14/2006 Closed Maureen Observational AVF4349n 1-SF 9 Genentech An Observational Study of Treatment Patterns and Safety Outcomes for or Locally Recurrent Cancer Sterling Closed Madelyn NSCLC 30704 0 A Randomized Phase II Study to Assess the Efficacy of Pemetrexed or Sunitinib or Pemetrexed plus Sunitinib in the Secondline Treatment of Advanced NSCLC Sunitinib Pemetrexed HOLD all sites Cross 11/6/2008 Maureen
SPONSOR Title Provided Colorectal 20060141 5 Amgen A Multi-center, Open-label, Randomized, Phase II Clinical Trial Evaluating Safety and Efficacy of FOLFIRI with Either Panitumumab or Bevacizumab as Secondline Treatment in Subjects with Colorectal Cancer Panitumumab Closed JOHA FOLFIRI, Bevacizumab Quorum West & Morris 12/29/2006 Only Karen DLBCL 50303 1 Phase III Randomized Study of R-CHOP v. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreatred De Novo DLBCL R-CHOP EPOCH-R Cross 5/1/2008 Closed Maureen