Trial & Business Updates:

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Priority Lists

Activations

S0916Phase II

Activation

A Phase II Trial of the Anti-CCR2 Antibody MLN1202 in Patients with Bone Metastases
Study Coordinator(s)Kenneth J. Pienta, M.D., John Sarantopolous, M.D.
ParticipantsLimited: Institutions Listed on SWOG Activation Memorandum

Closures

S9925Ancillary

Permanent Closure effective March 15, 2010

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
Closure Date2010-03-15

Amendments, Revisions, Memoranda

C10403Phase II Intergroup

Revision #3

An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
Action CodesIP, ER
Study Coordinator(s)Anjali S. Advani, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, Pathologists
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
S0349Phase II

Memorandum - Withdraw of NCI IND effective January 14, 2010.

Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) with Advanced Stage Diffuse Large B-cell NHL of Low and Low-Intermediate IPI Risk
Action CodesNR
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0520Phase II

Memorandum - PXD101 Safety Report

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 - Updated Everolimus Order Form

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 CodesNR
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
S0600Phase III

Revision #2

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 CodesIP, AC, ER
Study Coordinator(s)Philip Gold, M.D., Anthony Shields, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0635Phase II

Memorandum - OSI-774 Safety Report

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 - OSI-774 Safety Report

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

Memorandum - Clarification of Section 5.3

A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori
Action CodesNR
Study Coordinator(s)E. Robert Greenberg, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0703Phase II

Memorandum - Azacitidine Safety Report

A Phase II Trial of Azacitidine Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
Action CodesER
Study Coordinator(s)Sucha Nand, M.D., John E. Godwin, M.D., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Members, Medical Oncologists, Pathologists
S0711Phase I

Memorandum - Advion Pharmacokinetic Site Manual

Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517; IND-73969) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction."
Action CodesNR
Study Coordinator(s)John Sarantopolous, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0727Phase I-II

Memorandum 1 of 2 - OSI-774 Safety Report

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 CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0727Phase I-II

Memorandum 2 of 2 - IMC-A12 Safety Report

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 CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0801Phase II

Revision #2

A Phase II Study of Iodine-131 Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma
Action CodesER
Study Coordinator(s)Jonathan W. Friedberg, M.D., Oliver W. Press, M.D.,Ph.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0826Phase II

Revision #4

A Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma
Action CodesER
Study Coordinator(s)Christopher D. Lao, M.D., M.P., John Fruehauf, M.D.,Ph.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