OBJECTIVES:

• Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.
• Determine the nature and degree of toxicity of this drug in these patients.
• Determine the progression-free and overall survival of patients treated with this drug.
• Determine the frequency of clinical response in patients treated with this drug.
• Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.
• Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 55-62 patients will be accrued for this study within 2.2-2.5 years.

DISEASE CHARACTERISTICS:

• 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)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2 (patients who have received 1 prior regimen)
• GOG 0-1 (patients who have received 2 prior regimens)

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• No known bleeding disorder or coagulopathy
• No active bleeding

Hepatic:

• 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

Renal:

• Creatinine ≤ 1.5 times ULN OR
• 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

Cardiovascular:

• 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

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior immunologic therapy directed at malignancy
• No prior bevacizumab
• No other concurrent immunotherapy directed at malignancy

Chemotherapy:

• See Disease Characteristics
• 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

Endocrine therapy:

• At least 1 week since prior hormonal therapy directed at malignancy
• No concurrent hormonal therapy directed at malignancy
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• Recovered from prior radiotherapy
• No concurrent radiotherapy directed at malignancy

Surgery:

• See Disease Characteristics
• 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

Other:

• At least 3 weeks since other prior therapy directed at malignancy
• No prior anticancer therapy that would preclude study entry