Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:
• •* Metastatic disease
• •* Objective progression or rising prostate-specific antigen (PSA) despite androgen-deprivation therapy and antiandrogen withdrawal
• •Patients with rising PSA must demonstrate a rising trend with 2 successive elevations at a minimum interval of 1 week
• •* Minimum PSA of 5 ng/mL or new areas of bony metastases on bone scan required if no measurable disease
• •* No minimum PSA for measurable disease
• •Must have received ≤ 1 prior docetaxel-based chemotherapy for metastatic disease
• •No known CNS disease or brain metastases
• •Testosterone \< 0.5 ng/mL (castrate level)
• •* Concurrent luteinizing-hormone releasing-hormone agonist allowed to maintain castrate level
• •PATIENT CHARACTERISTICS:
• •Zubrod performance status 0-1
• •Life expectancy ≥ 12 weeks
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Hemoglobin ≥ 8.0 g/dL
• •Bilirubin normal
• •Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 50 mL/min
• •Urine protein:creatinine ratio ≤ 1.0 OR proteinuria ≤ 2+ by urine dipstick OR ≤ 1 g protein/24-hour urine collection
• •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
• •No significant traumatic injury within the past 28 days
• •Adequately controlled hypertension (defined as systolic blood pressure \[BP\] ≤ 150 mm Hg and/or diastolic BP ≤ 100 mm Hg on antihypertensive medications)
• •No history of hypertensive crisis or hypertensive encephalopathy
• •No New York Heart Association class II-IV congestive heart failure
• •No myocardial infarction or unstable angina within the past 6 months
• •No stroke or transient ischemic attack within the past 6 months
• •No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• •No symptomatic peripheral vascular disease
• •No evidence of bleeding diathesis or coagulopathy
• •No prior malignancy except adequately treated skin cancer or any other cancer in complete remission for ≥ 2 years
• •Able to swallow and retain capsules
• •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• •No serious nonhealing wound, ulcer, or bone fracture
• •No known hypersensitivity to any component of bevacizumab
• •No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab
• •No uncontrolled intercurrent illness, including, but not limited to, any of the following:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •No psychiatric illness or social situation that would preclude compliance with study requirements
• •No HIV positivity
• •No immune deficiency
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •More than 4 weeks since prior flutamide
• •More than 6 weeks since prior bicalutamide or nilutamide
• •At least 4 weeks since prior radiotherapy
• •At least 2 weeks since prior minor surgery
• •More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device)
• •More than 28 days since prior major surgery or open biopsy (8 weeks if high-risk procedure such as liver resection, thoracotomy, or neurosurgery)
• •Concurrent low-dose aspirin (≤ 325 mg/day) allowed
• •Concurrent anticoagulants allowed if patient has been on therapy ≥ 4 weeks and has no acute thromboembolic activity
• •No concurrent major surgery
• •No concurrent aprepitant
• •No concurrent immunosuppressive therapy
• •No concurrent combination anti-retroviral therapy for HIV-positive patients
• •No other concurrent antitumor therapy (including radiotherapy)
• •No other concurrent investigational agents