Trial & Business Updates:

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Priority Lists

Activations

Activation

Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
Action CodesER
Study Coordinator(s)Charles Schiffer, M.D.
ParticipantsCTSU
CTSU/N0723Phase III

Activation

MARVEL: Marker Validation of Erlotinib in Lung Cancer. A Phase III Biomarker Validation Study of Second-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib
Study Coordinator(s)Fred R. Hirsch, M.D.,Ph.D.
ParticipantsCTSU

Closures

S0325Phase IIb

Permanent Closure

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 CodesER
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
Closure Date2009-02-28
S0437Ancillary

Permanent Closure effective 3/1/09

Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed with Prostate Cancer
Action CodesER
Study Coordinator(s)Ian M. Thompson Jr., M.D., E. David Crawford, M.D.
ParticipantsPCPT Institutions with Participants who were Diagnosed with Prostate Cancer on or Before 12/31/03
Closure Date2009-03-01

Amendments, Revisions, Memoranda

Memorandum - Specimen Submission Instructions

Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
Action CodesER
Study Coordinator(s)Charles Schiffer, M.D.
ParticipantsCTSU
S0016Phase III

Memorandum: Specimen Submission Reminder

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 1 of 2 - Change in Cetuximab Supply

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
S0342Phase II

Memorandum 2 of 2 - 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
S0429Phase I Pilot

Memorandum 1 of 2 - Change in cetuximab supply

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
S0429Phase I Pilot

Memorandum 2 of 2 - 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
S0432Phase II Intergroup

Memorandum - R115777 Safety Report

Phase II Studies of Two Different Schedules and Two Different Doses of the Farnesyl Transferase Inhibitor R115777 (Tipifarnib, Zarnestra®, NSC-702818)for Previously Untreated Acute Myeloid Leukemia (AML) in Patients of Age 70 or Older.
Action CodesER
Study Coordinator(s)Harry P. Erba, M.D.,Ph.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU
S0434Phase II

Memorandum - BAY 43-9006 Safety Reports

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 #4

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
S0438Phase II Intergroup

Memoranda 1 of 2 - 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 CodesIP, AC, CBR, ER
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
S0438Phase II Intergroup

Memoranda 2 of 2 - R115777 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 CodesIP, AC, CBR, ER
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
S0438Phase II Intergroup

Revision #4

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 CodesIP, AC, CBR, ER
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 CodesIP, ER
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
S0505Phase II

Revision #4

Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
Action CodesIP, ER
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
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 CodesIP, ER
Study Coordinator(s)Ana Aparicio, M.D., Jeffrey S. Weber, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0512Phase II

Revision #3

Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination with Carboplatin and Paclitaxel in Patients with Metastatic Uveal Melanoma
Action CodesIP, ER
Study Coordinator(s)Ana Aparicio, M.D., Jeffrey S. Weber, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0512Phase II

Revision #3

Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination with Carboplatin and Paclitaxel in Patients with Metastatic Uveal Melanoma
Action CodesIP, ER
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
S0520Phase II

Memorandum - PXD101 Safety Reports

Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
Action CodesER
Study Coordinator(s)Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0528Phase I

Memorandum - GW572016 Safety Report

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
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 #3

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 1 of 2 - 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
S0536Phase II

Memorandum 2 of 2 - Cetuximab 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 CodesIP, ER
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0601Phase II

Revision #3

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 CodesIP, ER
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0605Phase II

Memorandum - CC-5013 Safety Report

A Phase II Study of Lenalidomide (Revlimid®) (NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Action CodesER
Study Coordinator(s)Mikkael A. Sekeres, M.D., M.S., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0622Phase II

Revision #3

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Action CodesIP, AC, CBR, ER
Study Coordinator(s)Anne F. Schott, M.D., Catherine Van Poznak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0629Phase II

Memorandum - Bortezomib Safety Reports

Observational study of asymptomatic Waldenström’s Macroglobulinemia and Phase II study of tandem autologous transplant and maintenance treatment for patients with symptomatic disease
Action CodesIP, AC, CBR, ER
Study Coordinator(s)Gordan Srkalovic, M.D., Ph.D
ParticipantsAffiliates, NCORP, Limited Institutions: SWOG Approved Autologous BMT Facilities, Medical Oncologists, Members, Pathologists
S0629Phase II

Revision #2

Observational study of asymptomatic Waldenström’s Macroglobulinemia and Phase II study of tandem autologous transplant and maintenance treatment for patients with symptomatic disease
Action CodesIP, AC, CBR, ER
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
S0711Phase I

Revision #1

Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517; IND-73969) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction."
Action CodesIP, AC, CBR, ER
Study Coordinator(s)John Sarantopolous, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
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
S0777Phase III Intergroup

Memorandum 1 of 2 - CC-5013 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 CodesIP, AC, CBR, ER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0777Phase III Intergroup

Memorandum 2 of 2 - 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 CodesIP, AC, CBR, ER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0777Phase III Intergroup

Revision #2

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 CodesIP, AC, CBR, ER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0809Phase II

Revision #1

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
Action CodesER
Study Coordinator(s)Edgar Ben-Josef, M.D., Mark Zalupski, M.D., Andrew M. Lowy, M.D., Christopher Corless, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Surgeons, Radiation Oncologists, CTSU
S9925Ancillary

Revision #12

Lung Cancer Specimen Repository Protocol, Ancillary
Action CodesER
Study Coordinator(s)Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, ECOG
  • 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