Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

Exclusion Criteria

• •Other malignancy within 5 years except non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder or head and neck
• •Concurrent anticancer therapy other than that of this study
• •Treatment with any anticancer drug within 28 days of day 1
• •Radiotherapy within 28 days of day 1
• •Any unresolved toxicity greater than NCI-CTCAE v 3.0 grade 2 from prior systemic anticancer therapy
• •Any prior therapy that targets the ErbB and/or VEGF pathways
• •Concurrent therapy with any NSAID
• •Known hypersensitivity characterized by acute bronchospasm, urticaria and/or rhinitis to NSAIDs, including aspirin
• •Serum creatinine \> 1.5 x ULN
• •Abnormal LFTs as outlined in protocol
• •Blood pressure \> 150/100mmHg
• •Active unstable angina, or myocardial infarction within 6 months
• •NYHA Grade II or greater congestive heart failure
• •History of stroke within 6 months
• •Clinically significant active peripheral vascular disease
• •Absolute neutrophil count \< 1000/mm3 or platelets \< 100,000/mm3
• •Evidence of bleeding diathesis or coagulopathy.
• •Tumor encasing the carotid artery, or other major vessel that in the opinion of the investigators is at risk for tumor-related hemorrhage
• •Presence of central nervous system or brain metastases
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
• •Minor surgical procedures such as fine needle aspiration or core biopsy within 5 days prior to day 1
• •Pregnant or lactating
• •History of abdominal fistula or intra-abdominal abscess within 6 months
• •History of gastrointestinal ulcer, perforation, or bleeding within 6 months
• •Serious non-healing wound or ulcer or active uncontrolled infection
• •Bone fracture within 28 days
• •Active substance abuse, defined by substance abuse of alcohol, cocaine or intravenous drug use within 6 months