Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer
OBJECTIVES:
- Compare the overall survival and progression-free survival in patients with
hormone-refractory, metastatic adenocarcinoma of the prostate treated with docetaxel
and estramustine vs mitoxantrone and prednisone.
- Compare the qualitative and quantitative toxic effects of these regimens in this
patient population.
- Compare the quality of life, including palliation of metastatic bone pain and global
quality of life, of patients treated with these regimens.
- Record prostate-specific antigen values for future correlations with response and
survival in patients treated with these regimens.
- Compare the responses in patients with bidimensionally measurable disease treated with
these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common
Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG
performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV
over 1 hour on day 2.
- Arm II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone
twice daily on days 1-21.
Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of
unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, after courses 4 and 8, and then at 1 year after
randomization.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 620 patients (310 per arm) will be accrued for this study
within 3.5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Daniel P. Petrylak, MD
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
CDR0000067211
NCT00004001
October 1999
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Mayo Clinic | Jacksonville, Florida 32224 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
Altru Health System | Grand Forks, North Dakota 58201 |