Spots Global Cancer Trial Database for SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
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Trial Identification
Brief Title: SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title: A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer
Study ID: NCT00006002
Conditions
Study Description
Brief Summary: RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the tumor. Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is not yet known whether SU5416 or dexamethasone is more effective in treating progressive prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of dexamethasone in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
City of Hope Medical Group, Pasadena, California, United States
University of Illinois at Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C., Decatur, Illinois, United States
Evanston Northwestern Health Care, Evanston, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
LaGrange Memorial Hospital, LaGrange, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Division of Hematology/Oncology, Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
Michiana Hematology/Oncology P.C., South Bend, Indiana, United States
Oncology Care Associates, P.L.L.C., Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Contact Details
Name: Walter M. Stadler, MD, FACP
Affiliation: University of Chicago
Role: STUDY_CHAIR
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