Trial & Business Updates:

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Priority Lists

Activations

S0111Phase II

Re-Activation Revision

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients with Hormone Refractory Prostate Cancer
Study Coordinator(s)Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Wael A. Sakr, M.D., Michael A. Tainsky, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0306Phase II

Activation

Phase II Study of Irinotecan in Patients with Advanced Transitional Cell Carcinoma of the Urothelium
Study Coordinator(s)Tomasz M. Beer, M.D., Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons

Closures

Amendments, Revisions, Memoranda

CTSU/E1697Phase III Intergroup

Revision #2

Phase III Randomized Study of Four Weeks of High Dose IFN-alpha2b in Stage T2b N0, T3a-b N0, T4a-b N0, and T1-4, N1a, 2a, 3(Microscopic) Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsCTSU
E5597Phase III

Amendment #1

Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
Study Coordinator(s)Omer Kucuk, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons
JMA17Phase III Intergroup

Revision #6

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Study Coordinator(s)Silvana Martino, D.O.
S0010Phase II

Revision #4

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-Cell Acute Lymphoblastic Leukemia (ALL)
Study Coordinator(s)Steven E. Coutre, M.D., David R. Head, M.D., David H. Boldt, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0029Phase II

Revision #1

Single Agent Docetaxel For Metastatic Breast Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)
Study Coordinator(s)Silvana Martino, D.O., Dorothy Coleman, R.N., M.S., Carolyn C. Gotay, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
S0102Phase II

Revision #2

Docetaxel and Vinorelbine Plus Filgrastim for HER-2 Negative, Stage IV Breast Cancer, Phase II
Study Coordinator(s)Julie R. Gralow, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP
S0107Phase II

Memorandum

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP
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
S0125Phase II

Amendment #1

A Phase II Study of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation in Older Patients With Acute Myeloid Leukemia (AML) in First Complete Remission (A BMT Study)
Study Coordinator(s)Peter A. McSweeney, M.D., Thomas R. Chauncey, M.D.,Ph.D., Scott I. Bearman, M.D., Anwar N. Mohamed, M.D., Cheryl L. Willman, M.D.
ParticipantsLimited Institutions: Allogeneic BMT Members
S0211Phase II

Memorandum

A Phase II Trial of STI571 for the Treatment of Platinum and Taxane Refractory Stage III and IV Epithelial Ovarian Cancer and Primary Peritoneal Cancer
Study Coordinator(s)Andy Jang, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
SWOG-9313Phase III Intergroup

Revision #5

Phase III Comparison of Adjuvant Chemotherapy with High-Dose Cyclophosphamide plus Doxorubicin (AC) versus Sequential Doxorubicin followed by Cyclophosphamide (A’C) in High-Risk Breast Cancer Patients with 0 - 3 Positive Nodes (Intergroup)
Study Coordinator(s)Hannah M. Linden, M.D., C. Kent Osborne, M.D.

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