Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed adenocarcinoma of the prostate
• •Prior treatment with androgen ablation including:
• •* Orchiectomy OR
• •* Luteinizing hormone-releasing hormone (LHRH) therapy (e.g., leuprolide)
• •* Patients on leuprolide must continue to receive the drug
• •Prior nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide) required
• •Metastatic disease with disease progression during androgen ablation, defined by at least 1 of the following:
• •* 2 consecutive increased prostate-specific antigen (PSA) levels measured at least 1 week apart
• •* More than 25% increase in bidimensionally measurable soft tissue metastases
• •* 20% increase in the sum of the baseline sum of longest diameter of measurable lesions
• •* Appearance of new lesions
• •* Appearance of new foci on a radionuclide bone scan
• •PSA greater than 10 ng/dL
• •Testosterone no greater than 50 ng/mL (castrate level)
• •No CNS metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •Over 18
• •Performance status:
• •Karnofsky 70-100%
• •Life expectancy:
• •More than 16 weeks
• •Hematopoietic:
• •WBC greater than 3,500/mm3
• •Absolute neutrophil count greater than 1,500/mm3
• •Platelet count greater than 100,000/mm3
• •Hemoglobin at least 8 g/dL
• •Hepatic:
• •AST and/or ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
• •Alkaline phosphatase no greater than 4 times ULN if AST/ALT no greater than ULN
• •Bilirubin no greater than ULN
• •Renal:
• •Creatinine less than 2.2 mg/dL
• •Cardiovascular:
• •No myocardial infarction within the past 6 months
• •No New York Heart Association class III or IV heart disease
• •No history of arterial or venous thrombosis
• •No cerebrovascular accident within the past year
• •Pulmonary:
• •No history of pulmonary embolism
• •Other:
• •Fertile patients must use effective contraception during and for 4 weeks after study
• •No peripheral neuropathy grade 2 or greater
• •No active infection
• •No serious concurrent medical illness that would preclude study
• •No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• •No other prior or concurrent active malignancy within the past 2 years except non-melanoma skin cancers
• •No other medical condition or reason that would preclude study
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •No prior chemotherapy for prostate cancer
• •Endocrine therapy:
• •See Disease Characteristics
• •At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and continued evidence of disease progression (rising PSA)
• •Prior steroids for prostate cancer allowed
• •No concurrent steroids except for pre-medication for docetaxel
• •Radiotherapy:
• •At least 4 weeks since prior radiotherapy
• •Surgery:
• •See Disease Characteristics
• •Other:
• •No concurrent herbal supplements to treat prostate cancer