Trial & Business Updates:

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Priority Lists

Activations

CTSU/E3805Phase III Intergroup

Activation

CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Action CodesER
Study Coordinator(s)Jorge A. Garcia, M.D.
ParticipantsCTSU

Closures

S0016Phase III

Permanent Closure

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 CodesER
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
Closure Date2008-10-02
S0515Phase II

Permanent Closure

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
Closure Date2008-09-15

Amendments, Revisions, Memoranda

CTN 0401Phase III Intergroup

Memorandum: BMTCTN memoranda #CTN-053, #CTN-054, & #0401-061

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
CTSU/E1697Phase III Intergroup

Memorandum

Phase III Randomized Study of Four Weeks of High Dose IFN-alpha2b in Stage T2b N0, T3a-b N0, T4a-b N0, and T1-4, N1a, 2a, 3(Microscopic) Melanoma
Action CodesNR
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsCTSU
E5597Phase III

Revision #9

Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
Action CodesER
Study Coordinator(s)Omer Kucuk, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons
JPR7Phase III Intergroup

Amendment #5

Intergroup (NCIC, SWOG) Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients with Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
Action CodesIP, AC, FBR
Study Coordinator(s)Celestia S. Higano, M.D.
ParticipantsUCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, NCORP, Members
R9813Phase IIb

Memorandum

A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
Study Coordinator(s)Geoffrey R. Barger, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
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
S0421Phase III Intergroup

Revision #2

Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
Action CodesIP, AC, ER
Study Coordinator(s)David I. Quinn, M.D., Ph.D, Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Mark G. Garzotto, M.D., Carol M. Moinpour, Ph.D., Philip C. Mack, Ph.D., Karen M. Baranowski, N.P.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, CTSU Institutions in the United States
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
S0500Phase III

Memorandum: Veridex Laboratory Holiday Closure

A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
Action CodesNR
Study Coordinator(s)Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States
S0509Phase II

Memorandum - AZD2171 Safety Report

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
S0536Phase II

Memorandum - Cetuximab Safety Report

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
S0622Phase II

Memorandum - Veridex Laboratory Holiday Closure

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Action CodesNR
Study Coordinator(s)Anne F. Schott, M.D., Catherine Van Poznak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0727Phase I-II

Memorandum - IMC-A12 Safety Reports

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
S0777Phase III Intergroup

Memorandum - BM Timepoint Error

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