Study of Bevacizumab/Doxil in Treatment of Platinum-Resistant/Refractory Ovarian Cancer (CA)
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Doxil; Avastin
Intervention description: Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1; First agent (Doxil) will be following by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression
Intervention MeSH terms: Bevacizumab; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety, tolerability, and effectiveness of
      two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin).
      How Doxil is metabolized and excreted from the body will also be studied.
    

Eligibility criteria:

        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