Irinotecan and Bevacizumab for Recurrent Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Irinotecan; Bevacizumab
Intervention MeSH terms: Bevacizumab; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: antibody therapy; chemotherapy; biologic therapy; combination therapy

Summary:

      The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in the
      treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when
      combined with bevacizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary
             peritoneal carcinoma

          -  Patient should have measurable or evaluable disease as defined by the following.

          -  Measurable disease: At least one lesion that can be accurately measured in at least
             one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when
             measured by conventional techniques, including palpation, plain x-ray, CT and MRI, or
             ≥ 10 mm when measured by spiral CT.

          -  Evaluable (nonmeasurable) disease: Patients who do not meet measurable criteria will
             be eligible having known disease with CA125 levels >50 U/mL on two occasions at least
             one week apart. They will be considered for CA125 response criteria.

          -  Any number of prior chemotherapy regimens

          -  Any number of prior bevacizumab-containing regimens

          -  No chemotherapy within the last 2 weeks prior to initiating this study.

          -  Karnofsky Performance status score ≥ 60%.

          -  Patients must have a life expectancy ≥ 12 weeks.

          -  Patients must be at least 18 years of age.

          -  Patients must understand and willingly sign an approved informed consent.

        Exclusion Criteria:

          -  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
             bevacizumab cancer study

          -  Active malignancy, other than superficial basal cell and superficial squamous (skin)
             cell, or carcinoma in situ of the cervix within last five years

        Bevacizumab-Specific Exclusions

          -  Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg
             and/or diastolic blood pressure > 100 mmHg)

          -  Prior history of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association (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 Known
             central nervous system disease, except for treated brain metastasis

          -  Treated brain metastases are defined as having no evidence of progression or
             hemorrhage after treatment and no ongoing requirement for dexamethasone, as
             ascertained by clinical examination and brain imaging (MRI or CT) during the screening
             period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may
             include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or
             equivalent) or a combination as deemed appropriate by the treating physician. Patients
             with CNS metastases treated by neurosurgical resection or brain biopsy performed
             within 3 months prior to Day 1 will be excluded

          -  Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
             recent peripheral arterial thrombosis) within 6 months prior to Day 1

          -  History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month
             prior to Day 1

          -  Evidence of bleeding diathesis or significant coagulopathy (in the absence of
             therapeutic anticoagulation)

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 1 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 Day 1

          -  History of abdominal fistula or gastrointestinal perforation within 6 months prior to
             Day 1

          -  Serious, non-healing wound, active ulcer, or untreated bone fracture

          -  Proteinuria as demonstrated by a UPC ratio >= 1.0

          -  Known hypersensitivity to any component of bevacizumab

          -  Pregnancy (positive pregnancy test) or lactation. Use of effective means of
             contraception (men and women) in subjects of child-bearing potential

          -  History of abdominal fistula or intra-abdominal abscess within 6 months prior to
             start.

          -  Any history of prior gastrointestinal perforation

          -  Patients believed to possibly be at higher than average risk of perforation, including
             symptoms or findings of partial or complete bowel obstruction, history of fistula,
             patients requiring parenteral nutrition and hydration, and those with history of prior
             perforation due to tumor or perforation within last 6 months from other causes will be
             excluded from study

          -  Patients with evidence of abdominal free air not explained by paracentesis