Trial & Business Updates:

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Priority Lists

Activations

Activation

A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer
Study Coordinator(s)Anne F. Schott, M.D.
ParticipantsCTSU
S0350Phase II

Activation

Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
Study Coordinator(s)Daruka Mahadevan, M.D.,Ph.D., Daniel O. Persky, M.D., Catherine Spier, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0511Phase II

Activation

A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer"
Study Coordinator(s)Zeina Nahleh, M.D., Abdul-Rahman Jazieh, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0517Phase II

Activation

A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
Study Coordinator(s)Mark H. Kirschbaum, M.D., Jasmine M. Zain, M.D., Lisa M. Rimsza, M.D., Raymond R. Tubbs, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists

Closures

S0341Phase II

Permanent Closure Effective 10/1/05

Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Study Coordinator(s)Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2005-10-01

Amendments, Revisions, Memoranda

R9813Phase IIb

Memorandum

A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
Study Coordinator(s)Geoffrey R. Barger, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0016Phase III

Revision #6

A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU
S0108Phase II

Memorandum

Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D., William T. Bellamy, R. Ph.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0200Phase III

Memorandum

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0202Phase II

Memorandum

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Study Coordinator(s)Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0218Phase II

Memorandum

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
Study Coordinator(s)Linda L. Garland, M.D., Michael Lobell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0218Phase II

Revision #2

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
Study Coordinator(s)Linda L. Garland, M.D., Michael Lobell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0220Phase II Intergroup

Amendment #3

A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
Study Coordinator(s)Michael J. Kraut, M.D., Katherine M. W. Pisters, M.D., Joshua Sonett, M.D., Charles R. Thomas Jr., M.D., Valerie W. Rusch, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG, NCIC-CTG, ACOSOG, NCCTG, CALGB
S0303Phase III

Memorandum (#1 of 2)

A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
Study Coordinator(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0303Phase III

Memorandum (#2 of 2)

A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
Study Coordinator(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0312Phase II

Memorandum

A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients with Advanced Renal Cell Cancer
Study Coordinator(s)Peter J. Van Veldhuizen, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0317Phase II

Memorandum

A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Study Coordinator(s)Michael S. Gordon, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG
S0330Phase II

Memorandum

U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
Study Coordinator(s)Karen H. Albritton, M.D., R. Lor Randall, M.D., Cheryl Coffin, M.D., Nancy Ratner, Ph.D., Scott Schuetze, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CTSU
S0336Phase II

Memorandum

Phase II Trial of Depsipeptide (NSC-630176) in Colorectal Cancer Patients Who Have Received Either One or Two Chemotherapy Regimens for Metastatic or Locally Advanced, Unresectable Disease
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0341Phase II

Memorandum

Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Study Coordinator(s)Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0342Phase II

Memorandum

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0355Phase I

Memorandum

A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
Study Coordinator(s)Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0400Phase II

Memorandum

A Phase II Study of Depsipeptide (NSC-630176) in Patients with Advanced Transitional Cell Carcinoma of the Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen for Advanced Disease
Study Coordinator(s)Daniel P. Petrylak, M.D., Guru Sonpavde, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists
S0412Phase II

Memorandum

A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination with Interferon Alpha 2b in Patients wtih Advanced Renal Cancer
Study Coordinator(s)Christopher W. Ryan, M.D., Tomasz M. Beer, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0414Phase II

Memorandum

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Study Coordinator(s)Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
S0415Phase II

Memorandum

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP
S0420Phase II

Memorandum

Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients with Recurrent or Metastatic Head and Neck Cancer
Study Coordinator(s)Stephen K. Williamson, M.D., Chao Hui Huang, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0515Phase II

Memorandum

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists

Other New Items

  • IP - Pts Must Be Informed
  • AC - Consent Must Be Amended
  • CBR - No Registration Allowed until IRB Review
  • RC - Formal Re-consent Required
  • FBR - Full Board Review Required
  • ER - Expedited Review Acceptable
  • NR - No IRB Review Required