• Progression-free survival at 6 months [ Designated as safety issue: No ]
  
• Frequency and severity of adverse effects as assessed by CTC [ Designated as safety issue: Yes ]
  

• Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
  
• Frequency of clinical response (partial and complete response) as assessed by RECIST criteria [ Designated as safety issue: No ]
  
• Prognostic factors, including initial performance status and age [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix.
• Determine the nature and degree of toxicity of this drug in these patients.
• Estimate the distribution of PFS and overall survival for patients treated with this drug.
• Determine the frequency of clinical response (partial and complete) in patients treated with this drug.
• Determine the role of age and initial performance status as prognostic factors in patients treated with this drug.
• Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks 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 19-51 patients will be accrued for this study within 11-38 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix

• Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix

  • Chemotherapy administered as a radio-sensitizer does not count as 1 regimen
• Documented disease progression

• At least 1 unidimensionally measurable lesion*

  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Tumors within a previously irradiated field are considered nontarget lesions unless documented evidence of progressive disease or biopsy-confirmed persistent disease at least 90 days after completion of radiotherapy
• No tumor involving major blood vessels
• No history or physical evidence of CNS disease, including primary or metastatic brain tumor
• Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2 (if received 1 prior regimen)
• GOG 0-1 (if 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 other active bleeding or pathologic condition that would confer a high risk of bleeding

Hepatic:

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• INR ≤ 1.5 (or 2-3 for patients on a 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

  • Urine protein < 1+ on dipstick or < 30 mg/dL OR
  • Urine protein < 1000 mg by 24-hour urine collection

Cardiovascular:

• No clinically significant cardiovascular disease
• No uncontrolled hypertension
• No myocardial infarction or unstable angina within the past 6 months
• No New York Heart Association grade II-IV congestive heart failure
• No serious cardiac arrhythmia requiring medication
• No grade II or greater peripheral vascular disease
• No history of stroke within the past 5 years

Other:

• No greater than grade 1 sensory or motor neuropathy
• No active infection requiring parenteral antibiotics
• No serious nonhealing wound, ulcer, or bone fracture
• No history or physical evidence of seizures not controlled with standard medical therapy
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
• No significant traumatic injury within the past 4 weeks
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior bevacizumab
• At least 3 weeks since prior immunologic agents for SCC of the cervix

Chemotherapy:

• See Disease Characteristics
• Recovered from prior chemotherapy
• No prior non-cytotoxic chemotherapy for persistent or recurrent disease

Endocrine therapy:

• At least 1 week since prior hormonal therapy for SCC of the cervix
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• Recovered from prior radiotherapy

Surgery:

• Recovered from recent prior surgery
• At least 4 weeks since prior major surgical procedure or open biopsy
• At least 1 week since prior placement of vascular access device or core biopsy
• No concurrent major surgical procedure

Other:

• At least 3 weeks since other prior therapy for SCC of the cervix
• No prior anticancer therapy that would preclude study therapy
• No concurrent anticoagulants other than those required to maintain the patency of indwelling IV catheters
• No concurrent chronic daily aspirin greater than 325 mg/day or other nonsteroidal anti-inflammatory medications that are known to inhibit platelet function at doses used for chronic inflammatory diseases