Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Inclusion Criteria

• •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