Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

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