A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer
- Compare the time to progression in patients with hormone refractory prostate cancer
treated with dexamethasone with or without SU5416.
- Determine the differences in PSA kinetics and PSA hazard score between these two
regimens in this patient population.
- Determine the objective response rate and time to development of new lesions in these
patients treated with SU5416.
- Determine the toxicity of SU5416 in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral dexamethasone once a day 6 days a week. Treatment
continues until disease progression, at which time patients cross over to arm II.
- Arm II: Patients receive oral dexamethasone as in arm I followed by SU5416 IV over 60
minutes twice weekly for 4 weeks. A smaller dose of dexamethasone is administered the
day after SU5416. Treatment continues for a minimum of 2 courses in the absence of
unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Walter M. Stadler, MD, FACP
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Evanston Northwestern Health Care||Evanston, Illinois 60201|
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Veterans Affairs Medical Center - Durham||Durham, North Carolina 27705|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Cancer Care Specialists of Central Illinois, S.C.||Decatur, Illinois 62526|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Fort Wayne Medical Oncology and Hematology, Inc.||Fort Wayne, Indiana 46885-5099|
|Michiana Hematology/Oncology P.C.||South Bend, Indiana 46617|
|Oncology Care Associates, P.L.L.C.||Saint Joseph, Michigan 49085|
|Division of Hematology/Oncology||Park Ridge, Illinois 60068|
|City of Hope Medical Group||Pasadena, California 91105|
|LaGrange Memorial Hospital||LaGrange, Illinois 60525|