Docetaxel in Treating Patients With Stage IV Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
Procedure: pain therapy
Procedure: quality-of-life assessment
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer|
|Study Start Date:||December 1998|
|Study Completion Date:||June 2003|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the efficacy of weekly docetaxel as measured by disease response, strength and duration of pain reduction, and either a decrease in analgesic use without an increase in pain, or a decrease in PSA, in patients with hormone refractory metastatic prostate cancer. II. Assess the efficacy of this regimen in terms of survival in this patient population. III. Evaluate the effect of this regimen on quality of life in these patients. IV. Determine qualitative and quantitative toxicities of this regimen in these patients.
OUTLINE: Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks. Courses repeat every 8 weeks. Therapy continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily pain medication diary is maintained during treatment. Patients are followed for 1 month or until resolution of toxicity, then every 3 months until death.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003781
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Study Chair:||Tomasz Beer, MD||OHSU Knight Cancer Institute|