Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00003614
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief 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 paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
- Detailed Description
OBJECTIVES: I. Determine the effect of weekly paclitaxel plus estramustine on PSA response in patients with metastatic hormone-refractory prostate cancer. II. Describe the toxic effects of this treatment in this patient population. III. Determine the effect of treatment on pain, asthenia, and quality of life. IV. Determine the objective response rate after treatment among the patients with bidimensionally measurable disease.
OUTLINE: Patients receive estramustine orally twice a day on days 1-3 of each week for 6 weeks. Patients also receive paclitaxel IV over 1 hour on day 2 of each week for 6 weeks. Courses repeat every 8 weeks in the absence of unacceptable toxicity and disease progression. Quality of life is assessed prior to treatment and at weeks 4, 8, 20, and 24. Patients are followed every 3 months for 2 years, every 6 months for years 2-5, and then annually thereafter.
PROJECTED ACCRUAL: There will be 17-52 patients accrued into this study over 14 months.
Recruitment & Eligibility
- Status
- COMPLETED
- 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 (28)
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
🇺🇸Chicago, Illinois, United States
Indiana University Hospitals
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
Pretoria Academic Hospital
🇿🇦Pretoria, South Africa
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States