Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer
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 I trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer. * Determine the safety and efficacy of this regimen in this patient population. OUTLINE: This is a dose escalation study of docetaxel. Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only. Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 12 months.
Interventions
DRUGcarboplatin
DRUGdocetaxel
DRUGestramustine phosphate sodium
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Disease progression following androgen ablation therapy (hormonal or surgical) by either: * Increase in the product of bidimensional diameters of 1 or more radiographically documented sites of measurable disease OR * Two consecutive increases in PSA documented over a previous reference value * First increase in PSA should occur a minimum of 1 week from the reference value and be confirmed * First PSA value is less than the previous value, then patient is eligible provided next PSA is greater than the second PSA * Testosterone levels documented in the castrate range (i.e., less than 30 ng/mL) PATIENT CHARACTERISTICS: Age: * 18 to 85 Performance status: * CALGB 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR * Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR * SGOT no greater than 1.5 times ULN and alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within past year * No significant change in anginal pattern within past 6 months * No New York Heart Association class II-IV heart disease * No deep venous thrombosis within past year Other: * No significant peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed except taxanes or platinum derivatives Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior antiandrogens Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics
Countries
United States
Outcome results
None listed