Erlotinib Hydrochloride and Surgery in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of Squamous Cell Carcinoma (SCC) of the Head and Neck: maxillary sinuses, oral cavity, oropharynx, hypopharynx, larynx, skin
• Assessed to be candidates for surgical treatment and have an already established date for surgery with a window of opportunity of at least 15 days
• Patients with SCC tumors will be eligible for this protocol only if they have additional biopsy tissue already saved in our Tumor Tissue Core Laboratory for research purpose or if they agree to have additional biopsies of tumor with adjacent normal tissue available for molecular studies
• Patients will only be eligible for this trial if they have tumor measurable on the CT scan or magnetic resonance imaging (MRI)
• No prior radiotherapy or chemotherapy for this tumor
• No chemotherapy, biologic therapy or hormonotherapy within the last one year
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) > 1,500/ul
• Platelet count > 100,000/ul
• Total bilirubin < 1.5
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 2 times the upper limit of normal
• Written informed consent must be obtained from all subjects prior to beginning therapy (subjects should have the ability to understand and be willing to sign a written informed consent document)

Exclusion Criteria:

• Patients with nasopharyngeal carcinoma
• Patients receiving any other investigational agents
• Patients who received prior treatment with EGFR inhibitors
• Subjects with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction [within prior 3 months], uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction)
• Subject with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan
• Patients with clinically significant ophthalmologic abnormalities
• Pregnant women are excluded; breastfeeding should be discontinued; men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control; subjects who are women of childbearing potential and sexually active males must be willing to use effective contraception while on study
• Human immunodeficiency virus (HIV)-positive subjects are excluded from the study