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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049257 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: carboplatin Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC) |
Estimated Enrollment: | 60 |
Study Start Date: | August 2002 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic disease with progression despite androgen ablation (orchiectomy or luteinizing hormone-releasing hormone [LHRH] analogues)
Disease progression defined as 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, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Principal Investigator: | Fairooz F. Kabbinavar, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000258050, UCLA-0202092, BMS-UCLA-020209201, NCI-G02-2121 |
Study First Received: | November 12, 2002 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00049257 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Genital Neoplasms, Male Prostatic Diseases Urogenital Neoplasms Carboplatin Antimitotic Agents Genital Diseases, Male Hormones |
Recurrence Paclitaxel Tubulin Modulators Adenocarcinoma Prostatic Neoplasms Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Mitosis Modulators Urogenital Neoplasms Antimitotic Agents Carboplatin Genital Diseases, Male |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Prostatic Neoplasms |