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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039104 |
RATIONALE: Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: BMS-275291 Drug: zoledronic acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II, Open-Label, Randomized Trial Of Zoledronic Acid (Zometa) And BMS-275291 (NSC#713763) In Patients With Hormone Refractory Prostate Cancer |
Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and participating center.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 21 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Metastatic bone disease documented by bone scan and confirmed by x-rays, CT scan, or MRI
Prostate-specific antigen (PSA) progression
Two consecutive increases in PSA values
Treatment with one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Roberto Pili, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069352, MAYO-MC0151, NCI-5361 |
Study First Received: | June 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00039104 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Zoledronic acid Prostatic Diseases Genital Neoplasms, Male Bone Density Conservation Agents Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Hormones Prostatic Neoplasms Recurrence |
Neoplasms Zoledronic acid Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Physiological Effects of Drugs |
Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |