Trial & Business Updates:

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Priority Lists

Activations

S0012Phase III

Activation

A Comparative Randomized Study of Standard Doxorubicin And Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin And Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory And Locally Advanced Breast Cancer
Study Coordinator(s)Georgiana K. Ellis, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, EPP, CTSU
S0102Phase II

Activation

Docetaxel and Vinorelbine Plus Filgrastim for HER-2 Negative, Stage IV Breast Cancer, Phase II
Study Coordinator(s)Julie R. Gralow, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP
S0109Phase II

Activation

A Phase II Study of Flavopiridol (NSC-649890) 1 Hour Bolus Days 1-3 Q 21 Days in Patients with Advanced Renal Cell Cancer
Study Coordinator(s)Peter J. Van Veldhuizen, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists

Closures

C19807Phase III Intergroup

Permanent Closure (effective 5/15/01)

A Phase III Study of Interferon-Refractory Patients with BCR/ABL (+) Chronic Myelogenous Leukemia (CML) Treated with Homoharringtonine (NSC-141633) Vs. Hydroxurea
Study Coordinator(s)Harry P. Erba, M.D.,Ph.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsPathologists, NCORP, Members
Closure Date2001-05-15
S9812Phase III Pilot

Permanent Closure: effective 6/1/01

Pilot Study of l-Selenomethionine in Prostate Cancer Patients Scheduled to Undergo Radical Prostatectomy
Study Coordinator(s)Anita L. Sabichi, M.D., Ian M. Thompson Jr., M.D., Brian J. Miles, M.D.
Closure Date2001-06-01

Amendments, Revisions, Memoranda

C9710Phase III Intergroup
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
E2496Phase III Intergroup
Randomized Phase III Trial of ABVD Versus Stanford V +/- Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin’s Disease with 0-2 Risk Factors
Study Coordinator(s)Richard I. Fisher, M.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Pathologists, NCORP
E2998Phase III
A Phase III Study of Flt3 Ligand (Flt3L) (NSC #696599) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
Study Coordinator(s)John E. Godwin, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP
N9831Phase III Intergroup
Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
S0008Phase III Intergroup

Revision #6

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
S0022Phase II

Revision #1

Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
Study Coordinator(s)Raja Mudad, M.D., FACP, Laurie E. Gaspar, M.D., R. Chapman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0031Phase II
Evaluation of ZD 1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
Study Coordinator(s)Daniel P. Petrylak, M.D., Peter J. Van Veldhuizen, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S9915Phase II

Revision #1

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
S9925Ancillary

Amendment #1

Lung Cancer Specimen Repository Protocol, Ancillary
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
S9927Phase III Intergroup

Revision #3

Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes, Phase III
Study Coordinator(s)Lori J. Pierce, M.D.
ParticipantsMedical Oncologists, Radiation Oncologists, Surgeons, NCCTG, RTOG, ACOSOG, ECOG, CALGB, NCORP, Members, NCIC-CTG, NSABP
SWOG-9427Phase II
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.

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