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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006002 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: dexamethasone Drug: semaxanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 16 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease defined by 1 of the following criteria:
Progressive disease, as defined above, despite adequate hormonal therapy defined by all of the following:
CNS metastasis allowed if:
Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
Cancer Center and Beckman Research Institute, City of Hope | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033-0804 | |
United States, Illinois | |
Cancer Care Specialists of Central Illinois, S.C. | |
Decatur, Illinois, United States, 62526 | |
LaGrange Memorial Hospital | |
LaGrange, Illinois, United States, 60525 | |
Division of Hematology/Oncology | |
Park Ridge, Illinois, United States, 60068 | |
Evanston Northwestern Health Care | |
Evanston, Illinois, United States, 60201 | |
Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Inc. | |
Fort Wayne, Indiana, United States, 46885-5099 | |
Michiana Hematology/Oncology P.C. | |
South Bend, Indiana, United States, 46617 | |
United States, Michigan | |
Oncology Care Associates, P.L.L.C. | |
Saint Joseph, Michigan, United States, 49085 | |
United States, North Carolina | |
Veterans Affairs Medical Center - Durham | |
Durham, North Carolina, United States, 27705 |
Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
Study ID Numbers: | CDR0000068010, UCCRC-10428, UCCRC-NCI-49, NCI-49 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006002 |
Health Authority: | United States: Federal Government |
stage IV prostate cancer recurrent prostate cancer |
Dexamethasone Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Prostatic Neoplasms SU 5416 Dexamethasone acetate Recurrence |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Glucocorticoids |
Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |