Trial & Business Updates:

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Priority Lists

Activations

S0301Phase II

Re-Activation

A Phase II Study of Induction With Daunorubicin, Cytarabine, and Cyclosporine All By Continuous IV Infusion for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older.
Study Coordinator(s)Thomas R. Chauncey, M.D.,Ph.D., Alan F. List, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0325Phase IIb

Activation

A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
Study Coordinator(s)Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG
S9811Phase II

Re-activation

Phase II Study of Hydroxyurea for Unresectable Meningioma
Study Coordinator(s)Lode J. Swinnen, M.D., Geoffrey R. Barger, M.D., Elisabeth J. Rushing, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, ECOG

Closures

G0182Phase III Intergroup

Permanent Closure

A Phase III Randomized Trial of Paclitaxel and Carboplatin Versus Triplet or Sequential Doublet Combinations in Patients with Epithelial Ovarian or Primary Peritoneal Carcinoma.
Study Coordinator(s)Amy D. Tiersten, M.D.
ParticipantsNCORP, Members, Surgeons, Pathologists
Closure Date2004-09-01
S0303Phase III

Permanent Closure

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
Closure Date2004-09-01
S0317Phase II

Temporary Closure

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
Closure Date2005-12-15
SWOG-9444Ancillary

Permanent Closure

Gastrointestinal Tumor Repository Protocol, Ancillary
Study Coordinator(s)Cecilia M. Fenoglio-Preiser, M.D., Grant N. Stemmermann, M.D., Amy E. Noffsinger, M.D., Paul E. Hurtubise, M.D.
ParticipantsMembers, Pathologists, NCORP
Closure Date2004-09-01

Amendments, Revisions, Memoranda

RTOG 0212Phase II-III Intergroup

Revision #2

A Phase II/III Randomized Trial of Two Doses (Phase III-Standard vs. High) and Two High Doe Schedules (Phase II-Once vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer
Study Coordinator(s)Zelanna Goldberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0001Phase III

Revision #8

A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma
Study Coordinator(s)Deborah T. Blumenthal, M.D., Alexander M. Spence, M.D., Keith J. Stelzer, M.D.,Ph.D., Andrew Edward Sloan, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Radiation Oncologists
S0202Phase II

Revision #2

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
S9704Phase III Intergroup

Amendment #7

A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas(with Possible Late Autologous Stem Cell Transplant) for Patients with Diffuse Aggressive Non-Hodgkin’s Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups (A BMT Study)
Study Coordinator(s)Patrick J. Stiff, M.D., Avayporn P. Nademanee, M.D., Richard I. Fisher, M.D., Louis S. Constine, M.D., Raymond R. Tubbs, D.O., James Cook, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, ECOG, NCIC-CTG
SWOG-8947Ancillary

Revision #14

Central Lymphoma Serum Repository Protocol
Study Coordinator(s)Richard I. Fisher, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
  • 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