A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer
OBJECTIVES:
- 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
16 months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
3 years
No
Walter M. Stadler, MD, FACP
Study Chair
University of Chicago
United States: Federal Government
10428
NCT00006002
June 2000
January 2006
Name | Location |
---|---|
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 |