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| Sponsor: | University of California, Davis |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00040755 |
Purpose
RATIONALE: BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Randomized phase II trial to study the effectiveness of BMS-275291 in treating patients who have prostate cancer that has not responded to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: rebimastat |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Randomized Phase II Trial Of BMS-275291 (NSC 713763, IND 62573) In Hormone Refractory Prostate Cancer |
| Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-7 vs 8-10), PSA level (less than 10 ng/mL vs 10-50 ng/mL vs 51-100 ng/mL vs more than 100 ng/mL), and concurrent bisphosphonate therapy (yes vs no). Patients are randomized to one of two treatment arms.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 24-68 patients (12-34 per treatment arm) will be accrued for this study within 5-14 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic disease
Hormone-refractory disease (despite androgen deprivation and antiandrogen withdrawal if applicable) defined by at least 1 of the following criteria:
Measurable or non-measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| United States, Illinois | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| 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 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| United States, Michigan | |
| Oncology Care Associates, P.L.L.C. | |
| Saint Joseph, Michigan, United States, 49085 | |
| Study Chair: | Primo N. Lara, MD | University of California, Davis |
More Information
| Study ID Numbers: | CDR0000069402, UCD-CHNMC-PHII-32, CHNMC-PHII-32, NCI-5615 |
| Study First Received: | July 8, 2002 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00040755 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |