A Phase II Evaluation Of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865, IND #7921) In The Treatment of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
Inclusion Criteria:
- Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- Recurrent or persistent after initial standard surgery or chemotherapy
- Incurable with standard surgery, chemotherapy, or radiotherapy
- At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Outside the area of prior radiotherapy
- Accessible to guided core needle biopsy
- Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin,
or another organoplatinum compound) for primary disease
- May have included high-dose therapy, consolidation, or extended therapy
administered after surgical or non-surgical assessment
- Patients with only 1 prior platinum-based chemotherapy regimen must have an
initial treatment-free interval of less than 12 months
- Patients with an initial treatment-free interval of more than 12 months must
have progressive disease after prior platinum-based chemotherapy regimen as
second-line therapy
- No tumors involving major blood vessels
- No evidence of CNS disease (primary brain tumor or brain metastases) within the past
5 years
- Ineligible for higher priority GOG protocols (i.e., active phase III GOG protocols
for the same patient population)
- Performance status - GOG 0-2 (patients who have received 1 prior regimen)
- Performance status - GOG 0-1 (patients who have received 2 prior regimens)
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- No known bleeding disorder or coagulopathy
- No active bleeding
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular
weight heparin)
- PTT < 1.2 times control
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 60 mL/min
- No proteinuria, as indicated by 1 of the following:
- Negative urine dipstick
- Urine protein < 30 mg/dL
- Urine protein < 1,000 mg on 24-hour urine collection
- No clinically significant cardiovascular disease, including any of the following:
- Uncontrolled hypertension
- Myocardial infarction within the past 6 months
- Unstable angina within the past 6 months
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Peripheral vascular disease ≥ grade 2
- No stroke within the past 5 years
- No pathologic condition that carries a high risk of bleeding
- No significant traumatic injury within the past 28 days
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No uncontrolled seizures within the past 5 years
- No neuropathy (motor and sensory) ≥ grade 2
- No serious non-healing wound, ulcer, or bone fracture
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human or humanized antibodies
- No active infection requiring parenteral antibiotics
- No known claustrophobia that would preclude MRI tolerance
- No ferromagnetic implants or pacers
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months
after study treatment
- At least 3 weeks since prior immunologic therapy directed at malignancy
- No prior bevacizumab
- No other concurrent immunotherapy directed at malignancy
- One additional prior cytotoxic regimen for recurrent or persistent disease allowed
- No prior non-cytotoxic chemotherapy for recurrent or persistent disease
- No concurrent chemotherapy directed at malignancy
- At least 1 week since prior hormonal therapy directed at malignancy
- No concurrent hormonal therapy directed at malignancy
- Concurrent hormone replacement therapy allowed
- Recovered from prior radiotherapy
- No concurrent radiotherapy directed at malignancy
- At least 28 days since prior major surgery or open biopsy and recovered
- At least 7 days since prior core biopsy or placement of vascular access device
- No anticipated need for major surgical procedure during study participation
- At least 3 weeks since other prior therapy directed at malignancy
- No prior anticancer therapy that would preclude study entry