Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically proven adenocarcinoma of the prostate with progressive metastatic or progressive regional nodal disease
• •* PSA evidence of progression defined as at least 50% increase over baseline on at least 2 measurements at least 2 weeks apart
• •Measurable disease preferred but not required
• •* Bone scan abnormalities acceptable provided PSA at least 10 ng/mL
• •* No minimum PSA value required if measurable disease present
• •Progression after or during an adequate trial of hormonal therapy
• •No more than 3 prior hormonal interventions for progressive disease
• •* One prior hormonal intervention is defined by any of the following:
• •* Concurrent testicular and adrenal androgen ablation (e.g., leuprolide, goserelin, orchiectomy, or diethylstilbestrol (DES) plus flutamide, bicalutamide, nilutamide, megestrol, or other antiandrogen)
• •* Initial LHRH agonist followed by orchiectomy provided no progression prior to orchiectomy
• •* Prior intermittent androgen deprivation on protocol SWOG-9346
• •* Corticosteroids for metastatic disease or in conjunction with aminoglutethimide or ketoconazole
• •* Two prior hormonal interventions are defined by the following:
• •* Antiandrogen given for disease progression more than 3 months after initial hormonal therapy
• •Prior neoadjuvant or adjuvant deprivation for treatment of nonmetastatic disease not considered a prior hormonal intervention
• •Antiandrogen withdrawal not considered a separate hormonal intervention
• •* At least 4 weeks since antiandrogen withdrawal or megestrol withdrawal
• •* Failure to respond to (i.e., no decrease in PSA at 2 and 4 weeks) or progression after a transient response to antiandrogen withdrawal or megestrol withdrawal required
• •Primary testicular androgen suppression (e.g., LHRH agonist or DES) continues during study
• •No brain metastases or other CNS disease
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •CALGB 0-2 OR
• •Zubrod 0-2
• •Life expectancy:
• •At least 3 months
• •Hematopoietic:
• •WBC at least 3,000/mm3
• •Absolute neutrophil count at least 1,200/mm3
• •Platelet count at least 100,000/mm3
• •Hemoglobin at least 9 g/dL
• •Fibrinogen at least 200 mg/dL
• •No prior hemorrhagic or thrombotic disorders
• •Hepatic:
• •Bilirubin normal
• •AST/ALT no greater than 2.5 times normal
• •Prothrombin time, partial thromboplastin time, and thrombin time normal
• •Renal:
• •Creatinine clearance at least 70 mL/min
• •Other:
• •No primary muscle disease
• •No active, uncontrolled bacterial, viral, or fungal infection
• •No grade 1 or worse peripheral neuropathy
• •No underlying medical condition that would preclude study
• •No other serious medical illness that limits survival to less than 3 months
• •No psychiatric condition that would preclude informed consent
• •No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer or adequately treated stage I or II cancer in remission
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior immunotherapy for metastatic disease
• •Chemotherapy:
• •No prior chemotherapy (including estramustine) for metastatic disease
• •Endocrine therapy:
• •No concurrent megestrol or other hormonal agents
• •No concurrent systemic or inhaled corticosteroids (intranasal and topical steroids allowed)
• •Radiotherapy:
• •At least 4 weeks since prior radiotherapy (8 weeks for strontium therapy)
• •Other:
• •No prior experimental therapy for metastatic disease
• •No concurrent heparin, warfarin, or aspirin