Study of Bevacizumab/Doxil in Treatment of Platinum-Resistant/Refractory Ovarian Cancer (CA)

Inclusion Criteria:

Patients must be platinum resistant

Patients will be included in the study based on the following criteria:

No prior anthracycline use
PS less or equal 2
Lab values within certain limits (ANC greater 1000, platelets greater 100,000; ALT, AST 2 time ULN, creatinine less 2.0)
No more than 3 prior chemotherapy regimens, only 2 of which can have included platinum-containing regimens
Use of effective means of contraception in subjects of child-bearing potential

Exclusion Criteria:

Disease-Specific Exclusions:

Evidence of complete or partial bowel obstruction
Need for IV hydration or TPN
Greater 2 prior abdominal surgeries
History of gastrointestinal perforation
Gastrointestinal perforation due to any other cause within the last 6 months

General Medical Exclusions:

Inability to comply with study and/or follow-up procedures
Life expectancy of less than 12 weeks
Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study

Avastin-Specific Exclusions

Inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure greater 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 6 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
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, 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 either:

Urine protein:creatinine (UPC) ratio 1.0 at screening OR
Urine dipstick for proteinuria greater or equal 2plus (patients discovered to have greater or equal 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate less or equal 1g of protein in 24 hours to be eligible)
Known hypersensitivity to any component of Avastin
Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential