Trial & Business Updates:

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Priority Lists

Activations

S0211Phase II

Activation

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

Closures

S0107Phase II

Temporary Closure effective 4/15/02

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
Closure Date2003-06-01

Amendments, Revisions, Memoranda

G0137Phase III Intergroup

Revison #2 (GOG Revisons #10 and #11)

A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
ParticipantsMembers, NCORP, Surgeons, Pathologists
JMA17Phase III Intergroup

Memorandum

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.
N9841Phase III Intergroup

Revision #6 (NCCTG Addendum #8)

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0001Phase III

Revision #2

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
S0009Phase II

Revision #4

Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
Study Coordinator(s)Amy D. Tiersten, M.D., Harriet O. Smith, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Surgeons
S0023Phase III Intergroup

Amendment #1

A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetacel followed by Maintenance Therapy with ZD1839 (NSC-715055) or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Study Coordinator(s)Karen Kelly, M.D., Laurie E. Gaspar, M.D., Wilbur A. Franklin, M.D., David R. Gandara, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, NCCTG, NCIC-CTG, CTSU, EPP
S0026Phase II

Revision #2

Evaluation of Interferon Alpha-2b and Thalidomide in Patients with Disseminated Malignant Melanoma, Phase II
Study Coordinator(s)Laura F. Hutchins, M.D., Joseph I. Clark, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0031Phase II

Amendment #1

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
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
S0108Phase II

Memorandaum

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
S0111Phase II

Revision #6

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
S0207Phase II

Revision #1

Phase II Study of Arsenic Trioxide in Male Patients with Refractory Germ Cell Malignancies
Study Coordinator(s)Tomasz M. Beer, M.D., Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons
S9900Phase III Intergroup

Revision #9

A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC).
Study Coordinator(s)Paul A. Bunn Jr., M.D., Katherine M. W. Pisters, M.D., Wilbur A. Franklin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Surgeons, CTSU, ECOG, NCCTG, RTOG, ACOSOG, NCIC-CTG
SWOG-9431Ancillary

Revision #10

Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary
Study Coordinator(s)Jeffrey A. Sosman, M.D., Vernon K. Sondak, M.D., Ralph J. Tuthill, M.D., Cecilia M. Fenoglio-Preiser, M.D., Marilyn L. Slovak, Ph.D., Robert P. Whitehead, M.D., Diane L. Persons, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG

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