Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic hormone-refractory adenocarcinoma of the prostate gland Elevated serum acid phosphatase or PSA levels must not be only evidence of disease Must have evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver, or lung metastases) Radiological evidence of hydronephrosis alone does not constitute evidence of metastatic disease Patients with bone metastases only (i.e., lacking measurable soft tissue disease) must have PSA level of at least 20 ng/mL Patients with soft tissue metastases and/or visceral disease must have either bidimensionally measurable disease or a PSA level of at least 20 ng/mL Must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g., estrogen therapy, LHRH-blocker plus flutamide, etc.) with evidence of treatment failure No carcinomatous meningitis or brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Granulocyte count at least 2,000/mm3 Platelet count greater than 100,000/mm3 No history of deep venous thrombosis Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No active angina pectoris No known New York Heart Association class II-IV heart disease No history of myocardial infarction in the last 6 months Other: No history of prior malignancy except if curatively treated and disease free for time period considered appropriate for cure of specific cancer No other serious concurrent illness or active infection Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy (including neoadjuvant chemotherapy) Endocrine therapy: See Disease Characteristics At least 6 weeks since prior bicalutamide At least 4 weeks since prior flutamide or nilutamide Recovered from prior toxicities of endocrine therapy Radiotherapy: No prior strontium 89, samarium 153, or other radioisotope therapies At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Recovered from prior surgery
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Veterans Affairs Medical Center - Chicago (Lakeside)
- CCOP - Central Illinois
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- Indiana University Hospitals
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- CCOP - Cedar Rapids Oncology Project
- CCOP - Ochsner
- New England Medical Center Hospital
- Beth Israel Deaconess Medical Center
- CCOP - Kalamazoo
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Veterans Affairs Medical Center - East Orange
- CCOP - Northern New Jersey
- University of Rochester Cancer Center
- CCOP - Merit Care Hospital
- Ireland Cancer Center
- CCOP - Geisinger Clinical and Medical Center
- University of Pennsylvania Cancer Center
- Fox Chase Cancer Center
- CCOP - MainLine Health
- Veterans Affairs Medical Center - Madison
- University of Wisconsin Comprehensive Cancer Center
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- Pretoria Academic Hospital