Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
Condition: Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Carcinoma, Ovarian Epithelial
Intervention: Bevacizumab; Abraxane
Intervention description: Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.; Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness and tolerability of the
      combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian
      cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life
      is during their treatment.
    

Eligibility criteria:

        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.