A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma

Inclusion Criteria:

- Measurable disease by CT or MRI.

- At least 1 "target lesion" to be used to assess response as defined by GOG RECIST
criteria.

- ECOG performance status of 0 or 1.

- Patient provides voluntary written informed consent.

- At least 18 years of age.

- Negative serum pregnancy test.

- Recovered from any recent surgery for at least 30 days and is free of active
infection.

- Received the following prior therapy at time of enrollment:

- Must have had 1 prior platinum-based chemotherapeutic regimen containing carboplatin,
cisplatin or organoplatinum. Initial therapy may have included high-dose therapy,
consolidation, or extended therapy. Patient should be defined as recurrent or
progression of disease within 6 months of last platinum chemotherapy.

- May have had 1 additional cytotoxic or non-cytotoxic chemotherapy regimen.

- Must have adequate hematologic and hepatic function.

Exclusion Criteria:

- Previously received bevacizumab.

- History of other invasive malignancy with the exception of nonmelanoma skin cancer.

- ECOG performance status of 2, 3, or 4.

- 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
bevacizumab cancer study. Patient must be bevacizumab naïve.

- Blood pressure of >150/100 mm Hg on antihypertensive medications.

- Prior history of hypertensive crisis or hypertensive encephalopathy.

- Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart
failure.

- History of myocardial infarction within 6 months of enrollment.

- History of stroke or transient ischemic attack within 6 months prior to study
enrollment.

- Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection)or
symptomatic peripheral vascular disease.

- Bleeding diathesis or coagulopathy.

- Presence of CNS or brain metastases.

- Pre-existing peripheral neuropathy of Grade ≥ 2.

- A 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.

- A partial or complete small or large bowel obstruction demonstrated radiologically
within 3 months prior to study enrollment.

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to study enrollment.

- Positive pregnancy test or is lactating.

- History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6
months prior to study enrollment.

- Serious, non-healing wound, ulcer, or bone fracture.

- Serious intercurrent medical or psychiatric illness, including serious active
infection.

- Inability to comply with study and/or follow-up procedures.

- Life expectancy of less than 12 weeks.

- Proteinuria at screening as demonstrated by either:

- Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR

- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on
dipstick urinalysis at baseline should undergo a 24 hour urine collection and must
demonstrate ≤ 1g of protein in 24 hours to be eligible).

- Known hypersensitivity to any component of bevacizumab.