Trial & Business Updates:

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Priority Lists

Activations

S0341Phase II

Activation

Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Study Coordinator(s)Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0356Phase II

Activation

Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Study Coordinator(s)Lawrence P. Leichman, M.D., Charles R. Thomas Jr., M.D., Kevin G. Billingsley, M.D., Thomas J. Watson, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
S0432Phase II Intergroup

Activation

Phase II Studies of Two Different Schedules and Two Different Doses of the Farnesyl Transferase Inhibitor R115777 (Tipifarnib, Zarnestra®, NSC-702818)for Previously Untreated Acute Myeloid Leukemia (AML) in Patients of Age 70 or Older.
Study Coordinator(s)Harry P. Erba, M.D.,Ph.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU

Closures

S0207Phase II

Temporary Closure

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
Closure Date2005-03-01
S0339Phase II

Permanent Closure

"A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)."
Study Coordinator(s)Angela M. Davies, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2004-10-01

Amendments, Revisions, Memoranda

AEWS0031Phase III Intergroup

Revision #2

Trial of Chemotherapy Intensification Through Interval Compression in Ewing Sarcoma and Related Tumors, Phase III
Study Coordinator(s)Karen H. Albritton, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Radiation Oncologists
E5597Phase III

Amendment #2

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
G0182Phase III Intergroup

Revision #10

A Phase III Randomized Trial of Paclitaxel and Carboplatin Versus Triplet or Sequential Doublet Combinations in Patients with Epithelial Ovarian or Primary Peritoneal Carcinoma.
Study Coordinator(s)Amy D. Tiersten, M.D.
ParticipantsNCORP, Members, Surgeons, Pathologists
S0016Phase III

Revision #5

A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, 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
S0108Phase II

Amendment #7

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
S0114Phase I-II

Amendment #1

An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Study Coordinator(s)Robert B. Montgomery, M.D., Mary L. Disis, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0204Phase II

Revision #7

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)
Action CodesER
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
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

Memorandum

Barriers to Accrual to Clinical Trials in Older (>= 65 Years) Cancer Patients
Study Coordinator(s)Julie R. Gralow, M.D., Antoinette J. Wozniak, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0330Phase II

Revision #1

U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
Study Coordinator(s)Karen H. Albritton, M.D., R. Lor Randall, M.D., Cheryl Coffin, M.D., Nancy Ratner, Ph.D., Scott Schuetze, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CTSU
S0331Phase II

Memorandum

A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study Coordinator(s)Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG
S0345Phase II

Memorandum

A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
Study Coordinator(s)Scott Schuetze, M.D.,Ph.D., Brian Rubin, M.D.,Ph.D., Michael C. Heinrich, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S9630Phase III Intergroup

Revision #14

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
S9910Ancillary

Revision #9

Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary
Action CodesER
Study Coordinator(s)Cheryl L. Willman, M.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, Affiliates
S9925Ancillary

Amendment #9

Lung Cancer Specimen Repository Protocol, Ancillary
Action CodesFBR
Study Coordinator(s)Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, ECOG
SWOG-9346Phase III Intergroup

Revision #20

Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
Study Coordinator(s)Maha H.A. Hussain, M.D., Celestia S. Higano, M.D., Brian J. Miles, M.D., Paul H. Lange, M.D., E. David Crawford, M.D., Donna L. Berry, R.N.,Ph.D., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, EORTC, EPP, NCIC-CTG

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