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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Eligibility 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
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- NCI - Center for Cancer Research