Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy

Exclusion Criteria

• •Inability to comply with study and/or follow-up procedures.
• •Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications).
• •Any prior history of hypertensive crisis or hypertensive encephalopathy.
• •New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E).
• •History of myocardial infarction or unstable angina within last 12 months prior to study enrollment.
• •History of stroke or transient ischemic attack within 6 months prior to study enrollment.
• •Known CNS disease.
• •Significant vascular disease (e.g., aortic aneurysm, aortic dissection).
• •Symptomatic peripheral vascular disease.
• •Evidence of bleeding diathesis or coagulopathy.
• •Patients on anticoagulants are allowed if patient has been on therapy for at least 4 weeks and patient has no acute thromboembolic activity.
• •Major surgical procedure, open biopsy, or significant traumatic injury within. 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
• •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
• •Serious, non-healing wound, ulcer, or bone fracture.
• •Proteinuria at screening as demonstrated by:
• •1\. Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening
• •Known hypersensitivity to any component of avastin.
• •Refusal to use effective means of contraception.
• •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to avastin.
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •Patients with immune deficiency such as HIV-positive patients or those receiving combination anti-retroviral therapy are excluded from the study because of lack of safety data for avastin in these patients.