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