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.
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
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.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV hormone
refractory adenocarcinoma of the prostate Symptoms and evidence of disease progression
despite standard hormonal therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: At
least 3 months Hematopoietic: WBC at least 3000/mm3 Neutrophil count at least 1500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of
normal (ULN) ALT no greater than 2 times ULN (no greater than 1.5 times ULN if alkaline
phosphatase is greater than 2.5 times ULN) Alkaline phosphatase no greater than 4 times
ULN (no greater than 8 times ULN if known bone involvement and bilirubin and ALT in normal
range) Renal: Not specified Other: At least 5 years since any prior malignancy except
nonmelanoma skin cancer No other significant medical illness that would prevent compliance
No hypersensitivity to drugs formulated with polysorbate-80 Must be able to complete
written questionnaires and diaries
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 1 month
since prior radiotherapy At least 2 months since prior strontium-89 Surgery: Not specified
Other: At least one month since prior investigational agents