Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate gland Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA) PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease) No elevated serum acid phosphatase or PSA level as the only evidence of disease No carcinomatous meningitis or brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy At least 12 weeks Hematopoietic White Blood Cell (WBC) ≥ 4,000/mm^3 OR Granulocyte count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine ≤ 2.0 mg/dL OR Creatinine clearance ≥ 50 mL/min Cardiovascular History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy No active angina pectoris No New York Heart Association class II-IV heart disease No myocardial infarction within the past 6 months No thrombosis within the past 3 months Other Fertile patients must use effective contraception during and for 3 months after study participation No active infection No other concurrent serious medical illness that would preclude study participation No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy See Disease Characteristics At least 4 weeks since prior flutamide At least 8 weeks since prior bicalutamide Radiotherapy More than 4 weeks since prior radiotherapy No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery See Disease Characteristics Other Recovered from all prior therapy No prior cytotoxic therapy for prostate cancer No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration