Trial & Business Updates:

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Priority Lists

Activations

S0028Phase II

Activation

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
S0107Phase II

Activation

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP

Closures

C9732Phase III Intergroup

Permanent Closure Effective 7/13/01

A Randomized Phase III Study Comparing Etoposide and Cisplatin with Etoposide, Cisplatin and Paclitaxel in Patients with Extensive Small Cell Lung Cancer
Study Coordinator(s)Karen Kelly, M.D.
ParticipantsMembers, Medical Oncologists, NCORP
Closure Date2001-07-13

Amendments, Revisions, Memoranda

C9710Phase III Intergroup

Revision #4

Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC #706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients with Untreated Acute Promyelocytic Leukemia
Action CodesER
Study Coordinator(s)Steven E. Coutre, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsPathologists, NCORP, Members
E1199Phase III Intergroup

Revision #2

A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paciltaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary Node-Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, Surgeons
E8892Phase III

Memorandum

Phase III Trial of Orchiectomy/LHRH Analog + Flutamide + Suramin + Hydrocortisone vs. Orchiectomy/LHRH Analog + Flutamide in Patients with Metastatic Prostate Cancer
Study Coordinator(s)A. Oliver Sartor, M.D.
JMA17Phase III Intergroup

Amendment #2 and Memorandum

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Study Coordinator(s)Silvana Martino, D.O.
N9741Phase III Intergroup

Memo regarding Oxaliplatin Safety Reports

A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, Surgeons, NCORP
N9841Phase III Intergroup

Memo regarding Oxaliplatin Safety Reports

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0003Phase III

Revision #3

Randomized Phase III Trial of Carboplatin and Paclitaxel plus Tirapazamine versus Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer Cisplatin, Paclitaxel, Tirapazamine vs. Cisplatin, Paclitaxel Specimen submission per S9925
Study Coordinator(s)Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, EPP, CTSU
S0004Phase I

Revision #4

A Phase I Study of Tirapazamine/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Coordinator(s)Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Janice Ryu, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0008Phase III Intergroup

Revision #9

Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D., John A. Thompson, M.D., Ralph J. Tuthill, M.D., John Vetto, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
S0013Biologic

Revision #1

Evaluation of In Vitro Assays as Predictors of Clinical Outcome in Patients With Locally Advanced (Stage IIB-IVA)Cervical Carcinoma, Biologic
Study Coordinator(s)Robert A. Burger, M.D., Bradley J. Monk, M.D., Sharon Wilczynski, M.D.,Ph.D., Robert S. Lavey, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0108Phase II

Amendment #1

Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D., William T. Bellamy, R. Ph.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S9915Phase II

Revision #3

A Phase II Study of PN401, 5-FU, and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach.
Study Coordinator(s)James H. Doroshow, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP
S9916Phase III Intergroup

Revision #7 & Memorandum

Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III.
Study Coordinator(s)Daniel P. Petrylak, M.D., Jeffrey A. Jones, M.D., Maha H.A. Hussain, M.D., Donna L. Berry, R.N.,Ph.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, CALGB, NCCTG, EPP, NCORP, Members, CTSU
S9917Phase III

Revision #4

L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic Intraepithelial Neoplasia
Study Coordinator(s)James R. Marshall, Ph.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D., E. David Crawford, M.D., Ian M. Thompson Jr., M.D., Donna L. Berry, R.N.,Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, VA Special Member Institutions
S9921Phase III Intergroup

Revision #7

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
Study Coordinator(s)L. Michael Glode, M.D., Maha H.A. Hussain, M.D., Gregory P. Swanson, M.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists, EPP, CALGB, CTSU Institutions in the United States
SWOG-9346Phase III Intergroup

Revision #16

Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
Study Coordinator(s)Maha H.A. Hussain, M.D., Celestia S. Higano, M.D., Brian J. Miles, M.D., Paul H. Lange, M.D., E. David Crawford, M.D., Donna L. Berry, R.N.,Ph.D., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, EORTC, EPP, NCIC-CTG
SWOG-9427Phase II

Memorandum

Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II
Study Coordinator(s)Louis E. Schroder, M.D., Mario A. Eisenberger, M.D., Daniel J. Culkin, M.D.
SWOG-9438Phase III

Amendment #7

Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma, A BMT Study, Phase III
Study Coordinator(s)Alexander Fefer, M.D., John A. Thompson, M.D., Patricia K. Lillis-Hearne, M.D.
ParticipantsLimited Institutions: BMT Members

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