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

OBJECTIVES:

• Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel, estramustine, and thalidomide.
• Determine the safety and toxicity of this regimen in these patients.
• Determine the efficacy of this regimen for pain control in these patients.

OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.

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