Trial & Business Updates:

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Priority Lists

Activations

Closures

S0327Phase II

Temporary Closure

A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer.
Study Coordinator(s)Primo N. Lara, Jr., M.D., Angela M. Davies, M.D., Paul H. Gumerlock, Ph.D., Wilbur A. Franklin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2004-09-15
S9811Phase II

Permanent Closure

Phase II Study of Hydroxyurea for Unresectable Meningioma
Study Coordinator(s)Lode J. Swinnen, M.D., Geoffrey R. Barger, M.D., Elisabeth J. Rushing, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, ECOG
Closure Date2005-06-01

Amendments, Revisions, Memoranda

S0106Phase III

Revision #1

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
Study Coordinator(s)Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, 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
S0205Phase III

Revision #3

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
S0303Phase III

Memorandum

A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
Study Coordinator(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0327Phase II

Memorandum

A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer.
Study Coordinator(s)Primo N. Lara, Jr., M.D., Angela M. Davies, M.D., Paul H. Gumerlock, Ph.D., Wilbur A. Franklin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0336Phase II

Revision #1

Phase II Trial of Depsipeptide (NSC-630176) in Colorectal Cancer Patients Who Have Received Either One or Two Chemotherapy Regimens for Metastatic or Locally Advanced, Unresectable Disease
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0338Phase II

Revision #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
S0339Phase II

Memorandum

"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
S0345Phase II

Amendment #1

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
S0355Phase I

Amendment #2

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

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