Trial & Business Updates:

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Priority Lists

Activations

CTSU/CALGB 30610Phase III Intergroup

Activation

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
Action CodesFBR
Study Coordinator(s)Shirish M. Gadgeel, M.D., Laurie E. Gaspar, M.D.
ParticipantsCTSU
CTSU/E2804Phase II Intergroup

Activation

The BeST Trial: A Randomized Phase II study of VEGF, RAF kinase and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma
Action CodesER
Study Coordinator(s)Kim A. Margolin, M.D.
ParticipantsCTSU
S0777Phase III Intergroup

Activation

A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU

Closures

Amendments, Revisions, Memoranda

N0426Phase II

Memorandum

A Phase II Study of Pemetrexed Disodium (ALIMTA) Plus Bevacizumab in Patients with Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)
Action CodesER
Study Coordinator(s)Ralph G Zinner, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0325Phase IIb

Amendment #5

A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
Action CodesIP, AC, FBR
Study Coordinator(s)Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG
S0325Phase IIb

Memorandum - Patient Reconsent to Extended Follow-Up

A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
Action CodesIP, AC, FBR
Study Coordinator(s)Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG
S0342Phase II

Memorandum - Cetuximab Safety Reports

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Action CodesER
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0412Phase II

Memorandum - BAY 43-9006 Safety Report

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
Action CodesER
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
S0429Phase I Pilot

Memorandum - Cetuximab Safety Reports

A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
Action CodesER
Study Coordinator(s)Yuhchyau Chen, M.D., Ph.D, Kishan J. Pandya, M.D., Karen Kelly, M.D., Derick H.M. Lau, M.D.,Ph.D., Laurie E. Gaspar, M.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists
S0434Phase II

Memorandum - BAY 43-9006 Safety Report

A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients with Relapsing or Resistant Multiple Myeloma
Action CodesAC, ER
Study Coordinator(s)Mohamad A. Hussein, M.D., Gordan Srkalovic, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0434Phase II

Revision #3

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

Memorandum - BAY 43-9006 Safety Report

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

Memorandum - BAY 43-9006 Safety Report

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
S0505Phase II

Memorandum - BAY 43-9006 Safety Reports

Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
Action CodesER
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

Memorandum - AZD2171 Safety Reports

A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Action CodesER
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 - BAY 43-9006 Safety Report

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
S0618Phase II

Memorandum - E7389 Safety Report

Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Action CodesER
Study Coordinator(s)Susanne M. Arnold, M.D.
ParticipantsMembers, NCORP, Affiliates
S0727Phase I-II

Memorandum - Clarification of Activation Notice

A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cancer
Action CodesNR
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, 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