A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed

Exclusion Criteria

• •Four or more treatment regimens
• •Prior therapy with bevacizumab or other VEGF pathway-targeted therapy
• •Current, recent (within 4 weeks of the first infusion of bevacizumab), or planned treatment with an experimental drug other than this Genentech-sponsored bevacizumab cancer study
• •Screening clinical laboratory values: Granulocyte count \<1500/uL; Platelet count \<75,000/uL; Hemoglobin \<8.5 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin \[Aranesp(R)\] is permitted); Serum bilirubin \>2.0 x upper limits of normal (ULN); Alkaline phosphatase, AST, and ALT \>2.5 x ULN (AST, ALT \>5 x ULN for subjects with liver metastasis); Serum creatinine \>2.0; International normalized ratio (INR) \>1.5 and activated partial thromboplastin time (aPTT) \>1.5 x ULN (except for subjects receiving anticoagulation therapy); Urine protein/creatinine ratio \>1.0 at screening
• •Blood pressure \>150/100 mmHg
• •Unstable angina
• •New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix B). Women who have received prior Doxil(R) therapy and have an ejection fraction \<50% will be excluded from the study.
• •History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab infusion)
• •History of stroke or transient ischemic attack within 6 months prior to Day 0
• •Clinically significant peripheral vascular disease
• •Evidence of bleeding diathesis or coagulopathy
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the course of the study
• •Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
• •Serious, non-healing wound, ulcer, or bone fracture
• •Presence of central nervous system or brain metastases
• •History of other malignancies within 5 years of Day 0, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer
• •Pregnant (positive pregnancy test) or lactating
• •Inability to comply with study and follow-up procedures
• •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications