Phase II Study of Weekly Paclitaxel by 1-HR Infusion Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma
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.
Interventional
Primary Purpose: Treatment
Gary R. Hudes, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000066691
NCT00003614
December 1998
Name | Location |
---|---|
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Indiana University Hospitals | Indianapolis, Indiana 46202 |