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Priority Lists

Activations

Activation

A Randomized, Placebo-controlled, Double-blind Trial Evaluating the Effect of Exemestane in Clinical cT1-3NO-1MO Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy
Study Coordinator(s)Laura F. Hutchins, M.D.
ParticipantsCTSU

Activation

A Clinical Trial Comparing Adjuvant Clodronate Therapy vs Placebo in Early Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Tamoxifen or No Therapy
Action CodesIP, ER
Study Coordinator(s)Julie R. Gralow, M.D.
ParticipantsCTSU
CTSU/E2100Phase III

Activation

A Randomized Phase III Trial of Paclitaxel versus Paclitaxel plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Study Coordinator(s)Julie R. Gralow, M.D.
ParticipantsCTSU

Activation

A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer
Study Coordinator(s)Peter F. Roberts, M.D.
ParticipantsCTSU

Activation

A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Verus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer
ParticipantsCTSU

Activation

A Phase III Comparison of Prophylactic Cranial Irradiation versus Observation in Patients with Locally Advanced Non-Small Cell Lung Cancer
Study Coordinator(s)Laurie E. Gaspar, M.D.
ParticipantsCTSU
S0114Phase I-II

Activation 11/1/02

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
S0124Phase III

Activation

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

Permanent Closure: 11/15/02

Enhancing Well-Being During Breast Cancer Recurrence
Study Coordinator(s)Carolyn C. Gotay, Ph.D., Carol M. Moinpour, Ph.D., Silvana Martino, D.O., Bonnie M. Taylor, Ph.D.
ParticipantsMedical Oncologists, NCORP, Members
Closure Date2002-11-15

Amendments, Revisions, Memoranda

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
E8897Intergroup

Revision #1

Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology with Outcome in Early Stage Nonseminomatous Germ Cell Tumor
Study Coordinator(s)Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists
G0182Phase III Intergroup

Revision #6

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
JBR10Phase III Intergroup

Memorandum

A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation
Study Coordinator(s)Robert B. Livingston, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, Surgeons, NCORP
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

Memorandum

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
S0010Phase II

Memorandum

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
S0107Phase II

Revision #8

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
S0218Phase II

Amendment #3

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
S9700Phase II

Memorandum

A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients with Locally Advanced Unresected Pancreatic Adenocarcinoma
Study Coordinator(s)William H. Isacoff, M.D.
ParticipantsMembers, NCORP
S9921Phase III Intergroup

Revision #13

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
Study Coordinator(s)L. Michael Glode, M.D., Maha H.A. Hussain, M.D., Gregory P. Swanson, M.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists, EPP, CALGB, CTSU Institutions in the United States
S9922Phase III

Memorandum

A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients with Refractory Multiple Myeloma
Study Coordinator(s)Mohamad A. Hussein, M.D., James K. Weick, M.D.
ParticipantsNCORP, Members
S9925Ancillary

Memorandum, Amendment #3

Lung Cancer Specimen Repository Protocol, Ancillary
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
S9927Phase III Intergroup

Amendment #2

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

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