S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy

You may be eligible if

• 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