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

This is an interventional treatment trial for Ovarian Cancer Read More

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:

1. 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

2. 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

3. 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