A Phase II Study of Bevacizumab in Combination With Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients With Locally Advanced Cervical Carcinoma

Inclusion Criteria:

- Histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cell
carcinoma of the uterine cervix, meeting 1 of the following stage criteria:

- Stage IIB-IIIB

- Stage IB-IIA disease with biopsy-proven pelvic node metastases and/or tumor size
>= 5 cm

- No positive para-aortic lymph nodes

- Zubrod performance status 0-2

- WBC >= 3,000/mm^3

- Absolute granulocyte count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- INR < 1.5

- Total bilirubin =< 1.5 mg/dL

- Serum creatinine =< 1.5 mg/dL

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- Serum calcium =< 1.3 times ULN

- Hemoglobin >= 10 g/dL (transfusion allowed)

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine
collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- None of the following illnesses or conditions:

- Medical illness preventing the use of full-dose chemotherapy

- Evidence of bleeding diathesis or coagulopathy

- Prior medical or psychiatric illness that would prevent informed consent or
limit survival to < 6 months

- History of aneurysms, cerebrovascular accident, or arteriovenous malformations

- Active gastrointestinal (GI) ulcers, GI bleeding, or active inflammatory bowel
disease

- Serious, nonhealing wound, ulcer, or current healing fracture

- History of any type of fistula or GI perforation

- Intra-abdominal abscess within the past 6 months

- No prior invasive malignancy (except nonmelanomatous skin cancer) unless disease free
for >= 3 years

- No significant traumatic injury within the past 28 days

- No clinically significant cardiovascular disease, such as the following:

- Uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication)

- Myocardial infarction within the past 12 months

- Unstable angina within the past 12 months

- New York Heart Association class II-IV congestive heart failure

- Unstable symptomatic arrhythmia requiring medication (i.e., chronic atrial
arrhythmia, atrial fibrillation, or paroxysmal supraventricular tachycardia)

- Arterial thromboembolic events, including transient ischemic attack or
clinically significant peripheral artery disease, within the past 6 months

- Arterial thromboembolic events, including transient ischemic attack or clinically
significant peripheral artery disease, within the past 6 months

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- No known HIV

- No prior organ transplant

- No prior surgery for carcinoma of the cervix other than biopsy

- No prior surgical debulking of pelvic or para-aortic nodes

- No prior pelvic radiotherapy, including transvaginal irradiation to control bleeding

- No prior systemic chemotherapy

- No major surgical procedure or open biopsy within the past 28 days or anticipation of
need for major surgical procedure during the course of the study

- No fine needle aspirations or core biopsies within the past 7 days

- No concurrent major surgical procedure

- No concurrent epoetin alfa or Hypericum perforatum (St. John's wort)

- No concurrent intensity-modulated radiotherapy

- No concurrent transvaginal irradiation to control bleeding