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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of suramin is more effective for prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborators: Eastern Cooperative Oncology Group; Southwest Oncology Group
• Treatments: Suramin

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