Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed adenocarcinoma of the prostate
• •* Metastatic disease
• •* Androgen-independent disease
• •Clinically progressive disease documented by at least 1 of the following parameters:
• •* Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart
• •* PSA ≥ 5.0 ng/mL
• •* Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)
• •* At least 1 new lesion on bone scan
• •* Progressive measurable disease
• •Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist
• •No brain metastases
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count \> 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3\*
• •Hemoglobin ≥ 7.5 g/dL\* NOTE: \*No transfusions within the past 2 weeks
• •Hepatic
• •AST and ALT \< 2.5 times upper limit of normal (ULN)
• •Bilirubin \< ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)
• •Alkaline phosphatase ≤ 2.5 times ULN OR
• •Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN
• •Renal
• •Creatinine ≤ 1.5 mg/dL OR
• •Creatinine clearance ≥ 40 mL/min
• •Cardiovascular
• •No transient ischemic attacks or cerebrovascular accident within the past 2 years
• •No myocardial infarction within the past 6 months
• •No uncontrolled congestive heart failure
• •No uncontrolled angina pectoris
• •No thromboembolic disease
• •Other
• •No peripheral neuropathy ≥ grade 2
• •No cognitive impairment that would preclude study participation or giving informed consent
• •No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma
• •Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior thalidomide
• •Chemotherapy
• •No prior docetaxel
• •No prior estramustine
• •No prior chemotherapy for metastatic prostate cancer
• •Endocrine therapy
• •See Disease Characteristics
• •Radiotherapy
• •Recovered from prior radiotherapy
• •Surgery
• •See Disease Characteristics
• •Recovered from prior surgery
• •Other
• •No concurrent antiretroviral therapy for HIV-positive patients
• •No concurrent complementary or alternative therapy that would interact with study drugs
• •No concurrent herbal or nutritional products or dietary supplements that would interact with study drugs
• •No concurrent aprepitant as secondary prophylaxis or antiemetic treatment