Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

This is an interventional treatment trial for Epithelial Ovarian Cancer Read More

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.