DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00024414
- Lead Sponsor
- Theradex
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
- Detailed Description
OBJECTIVES:
* Determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel.
* Determine the overall survival of patients treated with this drug.
* Determine the toxicity profile of this drug in these patients.
* Assess the quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 courses, and off study.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Lucille Parker Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States