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Priority Lists

Activations

S0347Phase III
A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With Her-2 Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy – Phase III
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph, Francisco J. Esteva, M.D., Ph.D
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0413Phase II

Activation

Phase II Study of GW572016 (NSC #727989) as First Line Therapy in Patients with Advanced or Metastatic Gastric Cancer
Study Coordinator(s)Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists

Closures

CTSU/E1899Phase III

Permanent Closure

A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) versus Docetaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients with a Rising PSA after Hormonal Therapy for Prostate Cancer
Study Coordinator(s)Nirmala Bhoopalam, M.D., Gregory P. Swanson, M.D.
ParticipantsCTSU
Closure Date2004-12-28

Amendments, Revisions, Memoranda

C89803Phase III Intergroup

Revision #4

A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC-616348) Plus Fluorouracil/Leucovorin (5FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection For Patients With Stage III Colon Cancer.
Study Coordinator(s)Alexander Hantel, M.D.
ParticipantsPathologists, NCORP, Members
C9581Phase III Intergroup

Revision #7

Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A vs. No Adjuvant Therapy Following Resection for Stage II (Modified Astler - Coller B2) Adenocarcinoma of the Colon.
Study Coordinator(s)R.L. Martino, M.D.
ParticipantsMembers, Surgeons, Pathologists, NCORP
C9710Phase III Intergroup

Memorandum

Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC #706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients with Untreated Acute Promyelocytic Leukemia
Action CodesER
Study Coordinator(s)Steven E. Coutre, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsPathologists, NCORP, Members
E4697Phase III Intergroup

Revision #4

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
E5597Phase III

Revision #3

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
S0033Phase III Intergroup

Amendment #3

"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
S0106Phase III

Memorandum

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
Action CodesER, NR
Study Coordinator(s)Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU
S0106Phase III

Revision #2

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
Action CodesER, NR
Study Coordinator(s)Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU
S0117Phase II

Memorandum

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg™) and Standard Dose Ara-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Study Coordinator(s)John E. Godwin, M.D., Margaret R. O'Donnell, M.D., David R. Head, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0124Phase III

Memorandum

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
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0313Phase II

Revision #3

Evaluation of CHOP Plus Involved Field Radiotherapy followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE and non-bulky Stages II and IIE, CD20 Positive, High-risk Localized, Aggressive Histologies of Non-Hodgkin's Lymphoma, Phase II
Study Coordinator(s)Thomas P. Miller, M.D., Louis S. Constine, M.D., B. Dino Stea, M.D.,Ph.D., Catherine Spier, M.D.
ParticipantsLimited: Institutions Listed on the Title Page

Revision #1

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
S0338Phase II

Amendment #1

Phase II Trial of Imatinib Mesylate (Gleevec) (NSC-716051) In Combination With Capecitabine (Xeloda) (NSC-712807) In Metastatic Breast Cancer
Study Coordinator(s)Helen K. Chew, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0349Phase II

Revision #2

Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) with Advanced Stage Diffuse Large B-cell NHL of Low and Low-Intermediate IPI Risk
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0412Phase II

Revision #1

A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination with Interferon Alpha 2b in Patients wtih Advanced Renal Cancer
Study Coordinator(s)Christopher W. Ryan, M.D., Tomasz M. Beer, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
  • 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