Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Exclusion Criteria

• •Prior chemotherapy or radiation therapy for HNSCC
• •Prior treatment with bevacizumab or other agents specifically targeting VEGF
• •Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.
• •Patients with nasopharyngeal carcinoma
• •Patients who will receive amifostine as part of the radiation treatment plan
• •Patients with skin breakdown/ulceration (CTCAE version 3.0, grade 2 or higher).
• •Patients with hearing loss requiring hearing aid or intervention (i.e. interfering in a clinical significant way with activities of daily living).
• •Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living).
• •History of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI) within the last 3 years.
• •Urine protein: creatinine (UPC) ratio ≥ 1.0 at screening. A random urine sample is collected. Total protein (mg/dL) and spot creatinine (mg/dL) are ordered for this sample. The UPC ratio is calculated from the results of these tests.
• •International normalized ratio (INR) \> 1.5 or activated partial thromboplastin time (aPTT) \> 1.5 X upper limits of normal (UNL),
• •Current use of warfarin, current use of heparin or low-molecular weight heparin, chronic daily treatment with aspirin (\> 325 mg/day) or nonsteroidal antiinflammatory medications known to inhibit platelet function. Treatment with dipyramidole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and or cilostazol (Pletal) is not allowed.
• •Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon of more) within 1 month prior to Day 1 protocol treatment will be excluded from this trial. Patients with incidental blood mixed with phlegm are not excluded.
• •Anatomic lesion that increases the risk of serious hemorrhage, such as encasement or invasion of major blood vessels by primary tumor and/or by involved lymph nodes
• •Blood pressure of \> 150/100 mmHg
• •New York Heart Association (NYHA) Grade II or greater congestive heart failure.
• •Clinically significant peripheral vascular disease
• •History of bleeding diathesis or hemorrhagic disorder, or coagulopathy.
• •Major surgical procedure or significant traumatic injury within 28 days prior to treatment with bevacizumab
• •Core biopsy within 15 days prior to treatment with bevacizumab.
• •Minor surgical procedures such as fine needle aspirations or placement of percutaneous gastrostomy tube (PEG) less than 7 days prior to treatment with bevacizumab
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior enrollment.
• •Inability to comply with study and/or follow-up procedures
• •Women who are pregnant or lactating