NCT00049257

Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin. * Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen. * Determine the safety and toxicity of this regimen in these patients. 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	Administered Day 1 of each cycle. AUC=6.
DRUG	paclitaxel	administered Days 1, 8, and 15 of each cycle. 100mg/m2

Timeline

• Start date: 2002-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2003-01-27
• Last updated: 2020-09-01
• Results posted: 2012-03-15

Locations

1 site across 1 country: United States