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| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Bristol-Myers Squibb |
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00049257 |
Purpose
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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC) |
| Enrollment: | 83 |
| Study Start Date: | August 2002 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Please see intervention descriptions
|
Drug: carboplatin
Administered Day 1 of each cycle. AUC=6.
Other Name: Paraplatin
Drug: paclitaxel
administered Days 1, 8, and 15 of each cycle. 100mg/m2
Other Name: Taxol
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with adequate hematological, renal, and hepatic function as defined by the following required laboratory values:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Fairooz Kabbinavar, MD / Principal Investigator, UCLA Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00049257 History of Changes |
| Other Study ID Numbers: | CDR0000258050, P30CA016042, UCLA-0202092, BMS-UCLA-020209201, NCI-G02-2121 |
| Study First Received: | November 12, 2002 |
| Last Updated: | February 9, 2010 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
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adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Carboplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |