Trial & Business Updates:

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Priority Lists

Activations

S0720Phase II

Activation

Phase II ERCC 1 and RRM1-Based Adjuvant Therapy Trial in Patients with Stage I Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Ralph G Zinner, M.D., Kemp H. Kernstine, M.D., Ph.D, Charles Williams, M.D., Philip C. Mack, Ph.D., Royce Calhoun, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists

Closures

S0528Phase I

Temporary Closure

Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989; IND-75,093) and Everolimus (RAD001; NSC-733504; IND-75,093) in Patients with Advanced Solid Tumors
Action CodesER
Study Coordinator(s)Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D., Patricia LoRusso, D.O., Jennifer Carew, Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
Closure Date2009-08-25

Amendments, Revisions, Memoranda

CTN 0401Phase III Intergroup

Memorandum: #CTN-055, #CTN-056, #0401-062, #0401-063, #0401-064

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
Action CodesER
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D.
ParticipantsLimited Institutions: BMT Members
E1905Phase II Intergroup

Revision #4

A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia with Multilineage Dysplasia
Study Coordinator(s)Harry P. Erba, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
N9831Phase III Intergroup

Memorandum - New Longterm Cardiac Reimbursement Form

Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
S0016Phase III

Memorandum: Notification of Bexxar Manufacturing Shutdown

A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Action CodesNR
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU
S0307Phase III

Memorandum - Clodronate Safety Reports

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Action CodesER
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
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
S0417Phase II

Memorandum - Bortezomib Safety Report

A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma
Action CodesER
Study Coordinator(s)Gordan Srkalovic, M.D., Ph.D, Mohamad A. Hussein, M.D., Joshua Epstein, DSC, John D. Shaughnessy, Jr., Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists
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
S0433Phase II

Memorandum: Notification of Bexxar Manufacturing Shutdown

Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study
Action CodesNR
Study Coordinator(s)Jonathan W. Friedberg, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical 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 CodesER
Study Coordinator(s)Mohamad A. Hussein, M.D., Gordan Srkalovic, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
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
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
S0505Phase II

Memorandum - BAY 43-9006 Safety Report

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- AZD7121 Safety Report

A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Action CodesIP, 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

Revision#4

A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Action CodesIP, 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 - 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
S0515Phase II

Memorandum - Bevacizumab Safety Reports

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
Action CodesER
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
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
S0533Pilot

Memorandum - Bevacizumab Safety Reports

A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Action CodesER
Study Coordinator(s)Antoinette J. Wozniak, M.D., Charles R. Thomas Jr., M.D., Karen Kelly, M.D., Laurie E. Gaspar, M.D., Philip C. Mack, Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0535Phase II

Revision #2

A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
Action CodesAC, ER
Study Coordinator(s)Jeffrey E. Lancet, M.D., Rami Komrokji, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsNCORP, Affiliates, Medical Oncologists, Members, Pathologists, CTSU
S0536Phase II

Memorandum - Bevacizumab Safety Reports

A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
Action CodesER
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0600Phase III

Memorandum - Bevacizumab Safety Reports

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
Action CodesER
Study Coordinator(s)Philip Gold, M.D., Anthony Shields, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0601Phase II

Memorandum - Bortezomib Safety Report

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
Action CodesER
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0629Phase II

Memorandum - Bortezomib Safety Report

Observational study of asymptomatic Waldenström’s Macroglobulinemia and Phase II study of tandem autologous transplant and maintenance treatment for patients with symptomatic disease
Action CodesER
Study Coordinator(s)Gordan Srkalovic, M.D., Ph.D
ParticipantsAffiliates, NCORP, Limited Institutions: SWOG Approved Autologous BMT Facilities, Medical Oncologists, Members, Pathologists
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
S0717Phase I-II

Memorandum - Bevacizumab Safety Reports

A Phase I and A Randomized Phase II Study of Maximal Angiogenic Blockade in Advanced Renal Carcinoma: Bevacizumab (NSC-704865) with or without MEDI-522 (NSC-719850)
Action CodesER
Study Coordinator(s)Christopher W. Ryan, M.D., Theresa M. Koppie, M.D., Philip C. Mack, Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0727Phase I-II

Revision #3

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
S0777Phase III Intergroup

Memorandum - Bortezomib Safety Report

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
Action CodesER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU

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