Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the prostate
• * Metastatic or recurrent disease
• No curative standard therapy exists
• Hormone-refractory disease
• * Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration
• * Documented PSA progression after completion of prior peripheral anti-androgens
• * At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart
• * Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation
• * Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation
• PSA ≥ 10 ng/mL at the time of study entry
• Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry
• Minimal symptomatic disease
• * No requirement for morphine or equivalent dose \> 30 mg/day to control pain
• No known brain metastases
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0-1
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No evidence of bleeding diathesis
• Hepatic
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Renal
• Serum creatinine normal OR
• Creatinine clearance ≥ 60 mL/min
• Cardiovascular
• No myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No active cardiomyopathy
• No unstable ventricular arrhythmia
• No uncontrolled hypertension
• Other
• No serious infection
• No active peptic ulcer disease
• No upper gastrointestinal or other condition that would preclude study compliance with oral medication
• No uncontrolled psychotic disorder
• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents
• No other serious illness or medical condition that would preclude study participation
• No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only
• Chemotherapy
• No prior chemotherapy
• No other prior cytotoxic chemotherapy
• Endocrine therapy
• See Disease Characteristics
• Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned
• Radiotherapy
• At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy
• Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed
• Surgery
• Not specified
• Other
• No prior investigational anticancer agents
• No concurrent therapeutic anticoagulation
• * Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer therapy
• No other concurrent investigational therapy
• No concurrent grapefruit juice
• Concurrent bisphosphonates allowed