Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

Inclusion Criteria

• •Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes
• •* Histologic WHO types I-IIb/III
• •Stage IIB-IVB disease
• •* No T1-2, N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes
• •No distant metastases
• •Zubrod performance status 0-1
• •WBC ? 4,000/mm?
• •Hemoglobin ? 9.0 g/dL
• •Platelet count ? 100,000/mm?
• •Absolute neutrophil count ? 1,500/mm?
• •INR ? 1.5
• •aPTT ? 1.5 times upper limit of normal (ULN)
• •Alkaline phosphatase ? 1.5 times ULN
• •ALT and AST ? 1.5 times ULN
• •Bilirubin ? 1.5 times ULN
• •Creatinine ? 1.5 mg/dL OR creatinine clearance ? 55 mL/min
• •Urine protein:creatinine (UPC) ratio \< 1.0
• •* If UPC \> 0.5, 24-hour urine protein must be \< 1,000 mg
• •Hearing loss primarily sensorineural in nature and requiring a hearing aid or intervention that interferes in a clinically significant way with activities of daily living allowed
• •Conductive hearing loss from tumor-related otitis media is allowed
• •No severe, active comorbidity, including any of the following:
• •* Ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy within the past 6 months
• •* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• •* Esophageal varices, nonhealing wound, nonhealing ulcer, or bone fracture within the past 6 months
• •* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
• •* Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the past 12 months
• •* Major medical or psychiatric illness that, in the opinion of the study investigator, would preclude study compliance
• •* Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics
• •* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• •* History of significant weight loss (\> 15% from baseline)
• •* History of arterial thromboembolic events
• •* Acquired immune deficiency syndrome
• •* Transmural myocardial infarction
• •* Cerebrovascular accident
• •* Transient ischemic attack
• •* Any other cardiac condition that, in the opinion of the investigator, would preclude study compliance
• •No gross hemoptysis or hematemesis, defined as bright red blood of ? 1 teaspoon per coughing episode, within the last 4 weeks (incidental blood mixed with phlegm allowed)
• •No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
• •Nutritional and physical condition considered suitable for study treatment
• •No significant traumatic injury within the past 4 weeks
• •No history of allergic reaction to the study drugs
• •No baseline blood pressure \> 150/100 mm Hg
• •No peripheral neuropathy ? grade 2
• •Not pregnant or nursing
• •Negative serum pregnancy test
• •Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
• •At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid (\> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function
• •No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
• •* More than 15 days since prior biopsies
• •More than 1 week since prior fine-needle aspirations or placement of percutaneous gastrostomy tube
• •More than 4 weeks since prior major surgical procedures
• •No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• •No prior bevacizumab or other vascular endothelial growth factor-targeting agents
• •No prior systemic chemotherapy for the study cancer
• •* Prior chemotherapy for a different cancer allowed
• •No concurrent hematologic growth factors (e.g. filgrastim \[G-CSF\], darbepoetin alfa, epoetin alfa) during study chemoradiotherapy
• •No concurrent prophylactic growth factors for neutropenia during study adjuvant therapy
• •No concurrent prophylactic amifostine or pilocarpine
• •No other concurrent experimental therapeutic cancer treatments