Trial & Business Updates:

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Priority Lists

Activations

S0520Phase II

Activation

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

Closures

S0009Phase II

Permanent Closure Effective 2/1/06

Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
Study Coordinator(s)Amy D. Tiersten, M.D., Harriet O. Smith, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Surgeons
Closure Date2006-02-01
S0211Phase II

Permanent Closure Effective 1/1/06

A Phase II Trial of STI571 for the Treatment of Platinum and Taxane Refractory Stage III and IV Epithelial Ovarian Cancer and Primary Peritoneal Cancer
Study Coordinator(s)Andy Jang, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
Closure Date2006-01-01

Amendments, Revisions, Memoranda

S0000Phase III

Amendment #3

Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Study Coordinator(s)Eric A. Klein, M.D., Ian M. Thompson Jr., M.D., Wael A. Sakr, M.D.
ParticipantsInstitutions listed in protocol Appendix 19.5
S0114Phase I-II

Revision #4

An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Study Coordinator(s)Robert B. Montgomery, M.D., Mary L. Disis, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0120Biologic

Revision #4

A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasma Proliferative Disorders
Action CodesER
Study Coordinator(s)Madhav V. Dhodapkar, M.D., Bart Barlogie, M.D.,Ph.D., John D. Shaughnessy, Jr., Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0200Phase III

Memorandum

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0218Phase II

Memorandum

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
Study Coordinator(s)Linda L. Garland, M.D., Michael Lobell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0317Phase II

Memorandum

A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Study Coordinator(s)Michael S. Gordon, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG
S0330Phase II

Memorandum

U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
Study Coordinator(s)Karen H. Albritton, M.D., R. Lor Randall, M.D., Cheryl Coffin, M.D., Nancy Ratner, Ph.D., Scott Schuetze, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CTSU
S0341Phase II

Memorandum

Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Study Coordinator(s)Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0342Phase II

Memorandum

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0412Phase II

Memorandum

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
S0413Phase II

Memorandum

Phase II Study of GW572016 (NSC #727989) as First Line Therapy in Patients with Advanced or Metastatic Gastric Cancer
Study Coordinator(s)Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0414Phase II

Memorandum

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Study Coordinator(s)Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
S0415Phase II

Memorandum

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP
S0420Phase II

Memorandum

Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients with Recurrent or Metastatic Head and Neck Cancer
Study Coordinator(s)Stephen K. Williamson, M.D., Chao Hui Huang, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0435Phase II

Memorandum

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Barbara J. Gitlitz, M.D., Bonnie S. Glisson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0514Phase II

Memorandum

Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma
Study Coordinator(s)Anthony El-Khoueiry, M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP
S0515Phase II

Memorandum

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.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