Trial & Business Updates:

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Priority Lists

Activations

Closures

CTSU/E1302Phase III

Permanent Closure effective 1/10/07.

Phase III Randomized, Placebo-Controlled, Trial of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib) in Performance Status 2 or Previously Treated Patients with Recurrent or Metastatic Head and Neck Cancer
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsCTSU
Closure Date2007-01-10
CTSU/E1697Phase III Intergroup

Permanent Closure to SWOG institutions effective 1/10/07

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
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsCTSU
Closure Date2010-10-27

Permanent Closure

A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer
Study Coordinator(s)Anne F. Schott, M.D.
ParticipantsCTSU
Closure Date2007-01-10
S0217Phase II

Permanent Closure effective 1/10/07.

Adjuvant Chemo-Radiotherapy with Combination of Cisplatin (NSC-119875)and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Coordinator(s)Prakash C. Neupane, M.D., Harold Kim, M.D., Stephen K. Williamson, M.D., George Yoo, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
Closure Date2007-01-10
S0306Phase II

Permanent Closure

Phase II Study of Irinotecan in Patients with Advanced Transitional Cell Carcinoma of the Urothelium
Study Coordinator(s)Tomasz M. Beer, M.D., Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons
Closure Date2007-02-01
S0325Phase IIb

Partial 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
S0427Phase III

Permanent Closure effective 1/10/07

A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, with and without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients with Advanced Oropharyngeal Squamous Cell Cancer
Action CodesER
Study Coordinator(s)David J. Adelstein, M.D., Gregory T. Wolf, M.D., P.G. Shankar Giri, M.D., Adel K. El-Naggar, M.D., Ph.D, Peggy A. Carroll, R.N.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CTSU
Closure Date2007-01-10
S0431Phase II

Permanent Closure effective 1/10/07

Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
Study Coordinator(s)Madeleine Kane, M.D., Ph.D, Adel K. El-Naggar, M.D., Ph.D, Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG
Closure Date2007-01-10

Permanent Closure

Nonmyeloablative Allogeneic Stem Cell Transplantation for Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation (A BMT Study)
Study Coordinator(s)Scott E. Smith, M.D., Ph.D, Patrick J. Stiff, M.D.
ParticipantsLimited Institutions: Allogeneic BMT Members
Closure Date2007-01-10
S0506Phase II

Permanent Closure effective 1/10/07

Phase II Trial of PS-341 (Bortezomib, NSC-681239) Followed by the Addition of Gemcitabine at Progression in Recurrent or Metastatic Nasopharyngeal Carcinoma
Study Coordinator(s)Sai-Hong Ignatius Ou, M.D., Ph.D, Stephen Shibata, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
Closure Date2007-01-10
S0511Phase II

Permanent Closure

A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer"
Study Coordinator(s)Zeina Nahleh, M.D., Abdul-Rahman Jazieh, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2007-01-10

Amendments, Revisions, Memoranda

E5597Phase III

Memorandum

Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
Study Coordinator(s)Omer Kucuk, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons
N0426Phase II

Memorandum

A Phase II Study of Pemetrexed Disodium (ALIMTA) Plus Bevacizumab in Patients with Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)
Study Coordinator(s)Ralph G Zinner, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0124Phase III

Memorandum

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0300Phase IIb

Revision #3

Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
Study Coordinator(s)Powel H. Brown, M.D., Ph.D, G. Thomas Budd, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0307Phase III

Memorandum

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
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
S0412Phase II

Revision #3

A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination with Interferon Alpha 2b in Patients wtih Advanced Renal Cancer
Study Coordinator(s)Christopher W. Ryan, M.D., Tomasz M. Beer, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists

Revision #3

Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men
Action CodesER
Study Coordinator(s)Christine B. Ambrosone, Ph.D., Regina M. Santella, Ph.D., Mary Reid, Ph.D., Philip C. Mack, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, CALGB, ECOG, NCCTG, RTOG
S0530Phase II

Revision #1

A Phase II Trial of Cytarabine and Clofarabine in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
Action CodesIP, AC, ER
Study Coordinator(s)Anjali S. Advani, M.D., Jerald P. Radich, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
SWOG-9217Phase III Intergroup

Memorandum

Chemoprevention of Prostate Cancer with Finasteride (ProscarĀ®), Phase III, Intergroup
Study Coordinator(s)Ian M. Thompson Jr., M.D., Michael K. Brawer, M.D., E. David Crawford, M.D.

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