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Keep this study
Lead
Dana-Farber Cancer Institute
With
National Cancer Institute (NCI)
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.
Age
18–85
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
