Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer

Date de début de l'étude : 1 octobre 1999

DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the prostate Unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: Progression of bidimensionally measurable disease Progression of evaluable but not measurable disease (bone scan) At least 2 consecutive rises in PSA and a PSA level of at least 5 ng/mL No minimum PSA required for measurable disease or non-PSA evaluable disease Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease Prior orchiectomy OR Medical castration using leuprolide or goserelin Luteinizing hormone-releasing hormone (LHRH) agonist therapy must continue during study Prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred No third-space fluid accumulation such as ascites or symptomatic pleural effusion No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-3 Performance status 3 must be due to pain secondary to bone metastases Life expectancy: Not specified Hematopoietic: No hypercoagulability Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of myocardial infarction No history of congestive heart failure unless well controlled No history of cerebrovascular accident or atrial fibrillation No active thrombophlebitis Left ventricular ejection fraction (LVEF) at least 50% by Multi Gated Acquisition Scan (MUGA) scan or 2-D echocardiogram Pulmonary: No history of pulmonary embolus Other: Recovered from major infections No other significant active medical illness No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No more than 1 prior biologic therapy regimen No concurrent biological response modifiers Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen No prior estramustine, taxanes, anthracyclines, or mitoxantrone No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior flutamide or ketoconazole (6 weeks for bicalutamide or nilutamide) No concurrent corticosteroids or hormonal therapy (except megestrol for hot flashes or continuing LHRH treatment) Radiotherapy: See Disease Characteristics Prior samarium Sm 153 lexidronam pentasodium allowed At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to 30% or more of bone marrow No prior strontium chloride Sr 89 No concurrent radiotherapy Surgery: See Disease Characteristics At least 3 weeks since prior surgery and recovered Other: At least 4 weeks since prior bisphosphonates No prior anticoagulation therapy (i.e., warfarin), except aspirin No concurrent bisphosphonates