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

OBJECTIVES:

Primary

• Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab.

Secondary

• Determine the toxicity of this regimen in these patients.
• Assess the prostate-specific antigen (PSA) response rate in patients treated with this regimen.
• Determine the overall survival of patients treated with this regimen.
• Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) in patients treated with this regimen.
• Correlate urine NTX and serum BSAP levels with time to progression in patients treated with this regimen.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral satraplatin on days 1-5. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 28-42 days.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

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