A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer

Date de début de l'étude : 1 mars 2004

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