Trial & Business Updates:

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Priority Lists

Activations

Closures

JMA17Phase III Intergroup

Partial Closure effective May 31, 2002

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
S0031Phase II

Temporary Closure Effective 6/1/02

Evaluation of ZD 1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
Study Coordinator(s)Daniel P. Petrylak, M.D., Peter J. Van Veldhuizen, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
Closure Date2002-10-15
S0112Phase II

TEMPORARY CLOSURE Effective May 15, 2002

S0112, A Phase II Study Of Daunomycin And Ara-C, Both Given 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., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Closure Date2003-04-01

Amendments, Revisions, Memoranda

S0003Phase III

Revision #7

Randomized Phase III Trial of Carboplatin and Paclitaxel plus Tirapazamine versus Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer Cisplatin, Paclitaxel, Tirapazamine vs. Cisplatin, Paclitaxel Specimen submission per S9925
Study Coordinator(s)Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, EPP, CTSU
S0033Phase III Intergroup

Memorandum

"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
S0101Phase II

Memorandum

A Phase II Study of Gemcitabine Plus Irinotecan (CPT-11) In Patients With Esophageal Cancer.
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0107Phase II

Revision #5

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
S0111Phase II

Revision #7

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
S0211Phase II

Amendment #1

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
S0218Phase II

Amendment #1

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
S9630Phase III Intergroup

Revision #8

A Randomized Comparison of Medroxyprogesterone Acetate (MPA) and Observation For Prevention of Endometrial Pathology in Postmenopausal Breast Cancer Patients Treated with Tamoxifen
Study Coordinator(s)Ronald K. Potkul, M.D., Caryl G. Salomon, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CALGB, NCORP
S9916Phase III Intergroup

Revision #10

Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III.
Study Coordinator(s)Daniel P. Petrylak, M.D., Jeffrey A. Jones, M.D., Maha H.A. Hussain, M.D., Donna L. Berry, R.N.,Ph.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, CALGB, NCCTG, EPP, NCORP, Members, CTSU
S9923Phase II

Memorandum

A Phase II Trial of R115777 (NSC #70818) in Patients with Advanced Colorectal Cancer.
Study Coordinator(s)Robert P. Whitehead, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9924Phase II

Memorandum

A Phase II Trial of R115777 (NSC #70818) in Patients with Advanced Pancreas Cancer.
Study Coordinator(s)John S. Macdonald, M.D., Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9927Phase III Intergroup

Revision #6

Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes, Phase III
Study Coordinator(s)Lori J. Pierce, M.D.
ParticipantsMedical Oncologists, Radiation Oncologists, Surgeons, NCCTG, RTOG, ACOSOG, ECOG, CALGB, NCORP, Members, NCIC-CTG, NSABP
SWOG-9438Phase III

Revision #9

Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma, A BMT Study, Phase III
Study Coordinator(s)Alexander Fefer, M.D., John A. Thompson, M.D., Patricia K. Lillis-Hearne, M.D.
ParticipantsLimited Institutions: BMT Members

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