Clinical Drug Experience Knowledgebase

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