Trial & Business Updates:

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Priority Lists

Activations

C90003Phase II

Activation

Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
Study Coordinator(s)Kim A. Margolin, M.D.
ParticipantsLimited Institutions: BMT Members
CTSU/MDA-3410Phase III Intergroup

Activation

A Prospective Randomized Phase III Trial Comparing Consolidation Therapy with or without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer
Action CodesER
Study Coordinator(s)Jacek Pinski, M.D.
ParticipantsCTSU
S0124Phase III

FOR IRB REVIEW ONLY

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU

Closures

JMA17Phase III Intergroup

Permanent Closure (effective 8/31/02)

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.
Closure Date2002-08-31
JMA17BAncillary

Permanent Closure (effective 8/31/02)

The Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen, A Companion Study to NCIC CTG MA.17
Study Coordinator(s)Robert B. Livingston, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, With Available Certified Hologic or Lunar Instrumentation
Closure Date2002-08-31

Amendments, Revisions, Memoranda

30987Phase III

Revision #1

Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
Study Coordinator(s)David C. Smith, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, RTOG, CTSU
N9741Phase III Intergroup

Revision #8

A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, Surgeons, NCORP
N9831Phase III Intergroup

Amendment #3 (NCCTG Addenda #8 and #9)

Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
S0001Phase III

Memorandum

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
S0013Biologic

Revision #3

Evaluation of In Vitro Assays as Predictors of Clinical Outcome in Patients With Locally Advanced (Stage IIB-IVA)Cervical Carcinoma, Biologic
Study Coordinator(s)Robert A. Burger, M.D., Bradley J. Monk, M.D., Sharon Wilczynski, M.D.,Ph.D., Robert S. Lavey, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0028Phase II

Revision #2

Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (And in a Cohort of Patients Younger Than 60 Years)
Study Coordinator(s)Derek Raghavan, M.D.,Ph.D., Maha H.A. Hussain, M.D., Daniel P. Petrylak, M.D., Carolyn C. Gotay, Ph.D., Dorothy Coleman, R.N., M.S., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
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
S0204Phase II

Amendment #1

A Phase II Trial of Thalidomide/Dexamethasone Induction Followed by Tandem Melphalan Transplant and Prednisone/Thalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients, (A BMT Study)
Study Coordinator(s)Mohamad A. Hussein, M.D., John D. Shaughnessy, Jr., Ph.D., James A. Waldron, M.D.,Ph.D., Jeffrey A. Zonder, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Limited Institutions: BMT Members
S9912Phase II

Amendment #2

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study Coordinator(s)Harriet O. Smith, M.D., Amy D. Tiersten, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Surgeons, Pathologists, NCORP
S9915Phase II

Memorandum

A Phase II Study of PN401, 5-FU, and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach.
Study Coordinator(s)James H. Doroshow, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP

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