Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: 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 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 Performance status - GOG 0-2 (if received 1 prior regimen) Performance status - GOG 0-1 (if received 2 prior regimens) 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 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 Creatinine ≤ 1.5 times ULN Creatinine clearance > 60 mL/min No proteinuria Urine protein < 1+ on dipstick or < 30 mg/dL Urine protein < 1000 mg by 24-hour urine collection 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 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 No prior bevacizumab At least 3 weeks since prior immunologic agents for SCC of the cervix See Disease Characteristics Recovered from prior chemotherapy No prior non-cytotoxic chemotherapy for persistent or recurrent disease At least 1 week since prior hormonal therapy for SCC of the cervix Concurrent hormone replacement therapy allowed See Disease Characteristics Recovered from prior radiotherapy 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 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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (bevacizumab)
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.