A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER

Date de début de l'étude : 1 janvier 1996

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