Trial & Business Updates:

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Priority Lists

Activations

S0221Phase III

Activation

"Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High -Risk Node Negative Breast Cancer"
Study Coordinator(s)G. Thomas Budd, M.D., Halle C.F. Moore, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0355Phase I
A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
Study Coordinator(s)Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D.
ParticipantsLimited: Institutions Listed on the Title Page

Closures

E4397Phase II Intergroup

Permanent Closure

A Phase II Trial of Preradiation in Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
Study Coordinator(s)Geoffrey R. Barger, M.D.
ParticipantsMembers, Medical Oncologists, NCORP
Closure Date2003-11-15
S0010Phase II

Temporary Closure

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
Closure Date2004-03-15
S0013Biologic

Permanent Closure: 11/15/03

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
Closure Date2003-11-15
S0111Phase II

Permanent Closure

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
Closure Date2003-11-15
SWOG-9342Ancillary
A Study of the Late Cardiac Effects of Two Different Adjuvant Chemotherapy Regimens in Women With Node Negative Breast Cancer Treated on SWOG-8897
Study Coordinator(s)Patricia A. Ganz, M.D., Laura F. Hutchins, M.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, NCORP
Closure Date2003-11-15

Amendments, Revisions, Memoranda

C19801Phase II Intergroup

Memorandum

A Phase II Study of 506U78 in Patients with Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)
Study Coordinator(s)Steven E. Coutre, M.D., Alison T. Stopeck, M.D.
ParticipantsPathologists, NCORP, Members
E4697Phase III Intergroup

Memorandum

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with "No Evidence of Disease" after Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Action CodesIP, AC, ER
Study Coordinator(s)Kim A. Margolin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, 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.
S0008Phase III Intergroup

Amendment #2

Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D., John A. Thompson, M.D., Ralph J. Tuthill, M.D., John Vetto, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
S0023Phase III Intergroup

Revision #10

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
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
S0109Phase II

Memorandum

A Phase II Study of Flavopiridol (NSC-649890) 1 Hour Bolus Days 1-3 Q 21 Days in Patients with Advanced Renal Cell Cancer
Study Coordinator(s)Peter J. Van Veldhuizen, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0200Phase III

Memorandum

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0213Phase II Pilot

Revision #3

Pilot Trial of Hyper-CVAD and Methotrexate/ARA C+ Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Study Coordinator(s)Elliot M. Epner, M.D., Ph.D, Thomas P. Miller, M.D., Catherine Spier, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0216Phase II

Revision #1

Docetaxel (NSC-628503), Cisplatin (NSC-119875), and 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed by Accerlerated Fractionation/Concomitant Boost Radiation and Concurrent Single Agent Cisplatin (NSC-119875), in Patients with Advanced Squamous Cell Head and Neck Cancer
Study Coordinator(s)David J. Adelstein, M.D., Ehab Hanna, M.D., P.G. Shankar Giri, M.D., S.G. Urba, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0220Phase II Intergroup

Revision #1

A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
Study Coordinator(s)Michael J. Kraut, M.D., Katherine M. W. Pisters, M.D., Joshua Sonett, M.D., Charles R. Thomas Jr., M.D., Valerie W. Rusch, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG, NCIC-CTG, ACOSOG, NCCTG, CALGB
S0222Phase II

Revision #1

A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Coordinator(s)Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D., Zelanna Goldberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
  • 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