Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer
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