Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

CTSU/NCCTG N0733Phase II Intergroup

Activation

"Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 in Patients with HER2 Positive Breast Cancer Previously Treated with Trastuzumab and an Anthracycline and/or a Taxane"
Action CodesER
Study Coordinator(s)Hannah M. Linden, M.D.
ParticipantsCTSU

Closures

Permanent Closure

The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study To NCIC CTG MA.27
Action CodesER
Study Coordinator(s)G. Thomas Budd, M.D.
ParticipantsCTSU
Closure Date2008-07-31

Permanent Closure

A Randomized Phase III Trial of Exemestane Versus Anastrozole With or Without Celecoxib in Postmenopausal Women With Receptor Positive Primary Breast Cancer
Action CodesER
Study Coordinator(s)G. Thomas Budd, M.D.
ParticipantsCTSU
Closure Date2008-07-31

Amendments, Revisions, Memoranda

C10403Phase II Intergroup

Memorandum - Withdrawal of FISH Specimen Submission Requirement

An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, Pathologists
E1905Phase II Intergroup

Revision #2

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
Action CodesIP, AC, CBR, ER
Study Coordinator(s)Harry P. Erba, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0232Phase III

Memorandum - Additional Data

Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Previously Untreated Multiple Myeloma who are Not Immediately Undergoing Autologous Stem Cell Transplant
Action CodesNR
Study Coordinator(s)Jeffrey A. Zonder, M.D., Bart Barlogie, M.D.,Ph.D., Muneer H. Abidi, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
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
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
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
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
S0518Phase III

Revision #1

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
S0528Phase I

Revision #4

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
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
S0536Phase II

Memorandum - 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
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

Revision #35

Cytogenetic Studies in Leukemia Patients
Action CodesER
Study Coordinator(s)Diane Roulston, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU, Affiliates

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