Trial & Business Updates:

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Priority Lists

Activations

S0600Phase III

Activation

Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX, or XELOX
Study Coordinator(s)Philip Gold, M.D., Anthony Shields, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0618Phase II

Re-activation

Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study Coordinator(s)Susanne M. Arnold, M.D.
ParticipantsMembers, NCORP, Affiliates

Closures

S0334Ancillary

Permanent closure effective 6/15/07

Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma
Study Coordinator(s)Diane L. Persons, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2007-06-15

Amendments, Revisions, Memoranda

CTN 0401Phase III Intergroup

Amendment #1 & Memorandum

Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin’s Lymphoma
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D.
ParticipantsLimited Institutions: BMT Members
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.
S0106Phase III

Revision #5

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
S0200Phase III

Revision #5

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
S0307Phase III

Memorandum

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Study Coordinator(s)Julie R. Gralow, M.D., Robert B. Livingston, M.D., Daniel F. Hayes, M.D., Dawn Hershman, M.D., M.S., Alison T. Stopeck, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CTSU
S0309Ancillary

Revision #7

Myeloma Specimen Repository Protocol, Ancillary
Action CodesER
Study Coordinator(s)Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0412Phase II

Memorandum

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
S0434Phase II

Memorandum

A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients with Relapsing or Resistant Multiple Myeloma
Action CodesER
Study Coordinator(s)Mohamad A. Hussein, M.D., Gordan Srkalovic, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0435Phase II

Memorandum

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Barbara J. Gitlitz, M.D., Bonnie S. Glisson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0438Phase II Intergroup

Memorandum

A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) with Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
Action CodesER
Study Coordinator(s)Kim A. Margolin, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D., Lawrence E. Flaherty, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, ECOG
S0500Phase III

Revision #2

A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
Study Coordinator(s)Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States
S0505Phase II

Memorandum

Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
Study Coordinator(s)Margaret von Mehren, M.D., John Goldblum, M.D., George Demetri, M.D., Vivien Bramwell, M.D.,Ph.D.
ParticipantsIntergroup Coalition Against Sarcomas Members, Members, NCORP, Affiliates, Medical Oncologists, CTSU
S0509Phase II

Amendment #4

A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Action CodesIP, AC, RC, FBR, ER
Study Coordinator(s)Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0509Phase II

Memorandum

A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Action CodesIP, AC, RC, FBR, ER
Study Coordinator(s)Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0512Phase II

Memorandum

Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination with Carboplatin and Paclitaxel in Patients with Metastatic Uveal Melanoma
Action CodesER
Study Coordinator(s)Ana Aparicio, M.D., Jeffrey S. Weber, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0517Phase II

Memorandum

A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
Study Coordinator(s)Mark H. Kirschbaum, M.D., Jasmine M. Zain, M.D., Lisa M. Rimsza, M.D., Raymond R. Tubbs, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0520Phase II

Memorandum

Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
Study Coordinator(s)Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0601Phase II

Amendment #1

A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0622Phase II

Memorandum

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Study Coordinator(s)Anne F. Schott, M.D., Catherine Van Poznak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists

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