Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer
Condition: Ovarian Cancer; Primary Peritoneal Serous Cancer; Fallopian Tube Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: bevacizumab
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avastin; bevacizumab

Summary:

      The purpose of this study is to evaluate how the participant's disease (ovarian, primary
      peritoneal serous, fallopian tube, or papillary serous endometrial cancer) responds to
      additional treatment with Avastin (bevacizumab). Participants have already received Avastin
      as part of maintenance therapy for their cancer. Maintenance therapy is a medical therapy
      that is given to people to prevent a relapse. However, cancer may return after maintenance
      therapy. This research study hopes to determine whether additional treatment with Avastin
      will be effective in treating the participant's cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed epithelial ovarian cancer, primary
             peritoneal serous cancer, papillary serous endometrial cancer, or fallopian tube
             cancer

          -  Must have responded and remained clinically stable (as defined by normal clinical
             examination, normal serum CA125 level and normal CT scan) after first-line
             platinum-based regimen followed by bevacizumab maintenance therapy

          -  Must have developed relapsed disease at least 3 months after completion of bevacizumab
             maintenance therapy as defined by a) development of new, measurable lesions by RECIST
             criteria, but no lesion with maximum diameter greater than 3 centimeters OR b) newly
             elevated CA125 level at least 2 x ULN on 2 separate occasions, obtained at least 1 day
             but not more than 3 months apart

          -  ECOG Performance Status 0-2

          -  No prior cytotoxic chemotherapy or biologic therapy for disease recurrence allowed

          -  Prior hormonal-based therapy for ovarian, primary peritoneal serous or fallopian tube
             cancer is allowed

          -  Toxic side effects related to prior chemotherapy or hormonal therapy must have
             resolved to grade one or less or to baseline before initiation of bevacizumab

          -  18 years of age or older

          -  Life expectancy of 6 months or greater

          -  Normal organ and marrow function as outlined in the protocol

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy or biologic therapy for disease recurrence

          -  Known CNS disease, except for treated brain metastasis

          -  Pregnancy or breast feeding

          -  Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to day 0, 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
             device, within 7 days prior to enrollment

          -  History of abdominal fistula, GI perforation, intra-abdominal abscess, or CT evidence
             of bowel obstruction or bowel wall thickening

          -  Symptoms of intestinal obstruction, or requirement of parenteral hydration and/or
             nutrition

          -  History of active malignancy during the last 3 years, except non-melanomatous skin
             cancer or in situ breast or cervical cancer

          -  Evidence of preexisting uncontrolled hypertension. If patient has hypertension, it
             must be medically controlled (< 150/90) prior to starting bevacizumab

          -  Proteinuria at screening

          -  Dementia or significantly altered mental status that would prohibit the understanding
             and/or giving of informed consent

          -  Therapeutic anticoagulation is not by itself and exclusion criterion. However, for
             certain high risk patients on therapeutic anticoagulation, eligibility will be
             determined after discussion with the overall PI

          -  Any active bleeding

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Prior history of hypertensive crisis or hypertensive encephalopathy

          -  NYHA Grade II or greater congestive heart failure

          -  History of myocardial infarction or unstable angina within 6 months prior to Day 1

          -  History of stroke or transient ischemic attack within 6 months prior to day 1

          -  Significant vascular disease within 6 months prior to day 1

          -  History of hemoptysis within 1 month prior to day 1

          -  Presence of measurable lesion(s) by RECIST criteria with maximum diameter greater than
             3 centimeters