Trial & Business Updates:

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Priority Lists

Activations

Closures

Permanent Closure

Phase III Randomized Trial of Preoperative Chemotherapy versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients with Stage IIIA (N2) Non-Small Cell Lung Cancer
Study Coordinator(s)Howard (Jack) West, M.D., David R. Gandara, M.D., Laurie E. Gaspar, M.D., Paul H. Gumerlock, Ph.D., Wilbur A. Franklin, M.D., Carol M. Moinpour, Ph.D.
ParticipantsCTSU
Closure Date2006-12-15
S0028Phase II

Permanent Closure Effective 12/15/06

Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (And in a Cohort of Patients Younger Than 60 Years)
Study Coordinator(s)Derek Raghavan, M.D.,Ph.D., Maha H.A. Hussain, M.D., Daniel P. Petrylak, M.D., Carolyn C. Gotay, Ph.D., Dorothy Coleman, R.N., M.S., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
Closure Date2006-12-15
S0215Phase II Pilot

Permanent Closure effective January 1, 2007

Docetaxel and Vinorelbine Plus Filgrastim with Weekly Trastuzumab for HER-2 Positive, Stage IV Breast Cancer, Phase II Pilot
Study Coordinator(s)Joseph J. Kash, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
Closure Date2007-01-01
S0219Phase II

Permanent Closure Effective 12/15/06

A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin with Molecular Correlates
Study Coordinator(s)Primo N. Lara, Jr., M.D., Ralph W. deVere White, M.D., Jeffrey P. Gregg, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Pathologists, Surgeons
Closure Date2006-12-15
S0301Phase II

Permanent Closure effective 12/15/06

A Phase II Study of Induction With Daunorubicin, Cytarabine, and Cyclosporine All By Continuous IV Infusion for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older.
Study Coordinator(s)Thomas R. Chauncey, M.D.,Ph.D., Alan F. List, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Closure Date2006-12-15
S0329Phase II

Permanent Closure effective Jan. 1, 2007.

Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Coordinator(s)Omer Kucuk, M.D., Richard H. Wheeler, M.D., Francis P. Worden, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2007-01-01
S0345Phase II

Permanent Closure effective 12/15/06

A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
Study Coordinator(s)Scott Schuetze, M.D.,Ph.D., Brian Rubin, M.D.,Ph.D., Michael C. Heinrich, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
Closure Date2006-12-15

Amendments, Revisions, Memoranda

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
S0325Phase IIb

Memorandum

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
S0331Phase II

Revision #6

A Phase II Trial of STI-571/Imatinib (GleevecĀ®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study Coordinator(s)Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG
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
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

Revision #2

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
S0429Phase I Pilot

Memorandum

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
S0514Phase II

Revision #1

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
S0517Phase II

Memorandum

A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
Study Coordinator(s)Mark H. Kirschbaum, M.D., Jasmine M. Zain, M.D., Lisa M. Rimsza, M.D., Raymond R. Tubbs, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0618Phase II

Revision #1

Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study Coordinator(s)Susanne M. Arnold, M.D.
ParticipantsMembers, NCORP, Affiliates
S9925Ancillary

Memorandum

Lung Cancer Specimen Repository Protocol, Ancillary
Action CodesNR
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
  • 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