Trial & Business Updates:

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Priority Lists

Activations

S1216Phase III

Memorandum - FOR IRB REVIEW ONLY

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Study Coordinator(s)Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY

Closures

S0927Phase III

Permanent Closure

Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain in Women with Early Stage Breast Cancer, Phase III
Action CodesER
Study Coordinator(s)Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, Affiliates, Pathologists
Closure Date2013-02-01
S1106Phase II Intergroup

Partial Permanent Closure - Arm 1

A Randomized Phase II Trial of R-HCVAD-MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients
Action CodesER
Study Coordinator(s)Steven Bernstein, M.D., Robert Chen, M.D., Stephen J. Forman, M.D., Louis S. Constine, M.D., Lisa M. Rimsza, M.D.
ParticipantsCTSU
Closure Date2013-06-26

Amendments, Revisions, Memoranda

S0500Phase III

Memorandum - Veridex Holiday Closure

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
Action CodesNR
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
S0502Phase III

Memorandum - Bevacizumab Safety Reports

A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
Action CodesER
Study Coordinator(s)Charles D. Blanke, M.D., Michael C. Heinrich, M.D., Christopher Corless, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0518Phase III

Memorandum - Bevacizumab Safety Reports

Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Action CodesER
Study Coordinator(s)James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0622Phase II

Memorandum - Veridex Holiday Closure

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Action CodesNR
Study Coordinator(s)Anne F. Schott, M.D., Catherine Van Poznak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0635Phase II

Memorandum - Bevacizumab Safety Reports

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
Action CodesER
Study Coordinator(s)Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0636Phase II

Memorandum - Bevacizumab Safety Reports

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
Action CodesER
Study Coordinator(s)Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0800Phase II

Memorandum - Bevacizumab Safety Reports

A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
Action CodesER
Study Coordinator(s)Zeina Nahleh, M.D., Daniel F. Hayes, M.D., Anne F. Schott, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, US INSTITUTIONS ONLY
S0925Phase II

Memorandum - IMC-A12 Safety Reports

A Randomized Phase II Study of Androgen Deprivation Combined with IMC-A12 Versus Androgen Deprivation Alone for Patients with New Hormone-Sensitive Metastatic Prostate Cancer
Action CodesER
Study Coordinator(s)Evan Y. Yu, M.D., Celestia S. Higano, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
S1005Phase II

Memorandum - MK-2206 Safety Report

A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
Action CodesER
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D.
ParticipantsMedical Oncologists, Members, NCORP, Affiliates
S1014Phase II

Memorandum - Abiraterone Acetate Safety Reports

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesER
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1115Phase II

Memorandum - MK-2206 Safety Report

Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
Action CodesER
Study Coordinator(s)Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1206 (8811)Phase II

Memorandum - ABT-888 Safety Report

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
Action CodesER
Study Coordinator(s)Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D.
ParticipantsSWOG

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