Phase II Study of Irinotecan in Combination With Bevacizumab for the Treatment of Recurrent Ovarian Cancer.
- Women with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary
- 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 CA-125 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.
- 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
- 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
CNS 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
- 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
- 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
- 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