Erlotinib Hydrochloride and Radiation Therapy in Treating Patients With Stage III-IV Squamous Cell Cancer of the Head and Neck

PRIMARY OBJECTIVES:I. To determine the time to progression of the combination of the EGFR
inhibitor erlotinib and radiation therapy. SECONDARY OBJECTIVES:I. To determine objective
response rate, locoregional control rate, duration of response, patterns of failure, overall
survival, toxicities and quality of life outcomes of the combination of erlotinib and
concurrent radiation therapy.II. To determine the pharmacokinetic profile of erlotinib.
Additional analyses of the pharmacokinetic data on patients receiving daily erlotinib
treatment via their feeding tube will be conducted. III. To determine the effect of
treatment and dose of treatment on biologic correlates in tumor tissue and/or surrounding
mucosa, EGFR expression and phosphorylation status, serum markers of angiogenic activity
VEGF, sVEGFR-2, sKIT, ICAM, PDGF, fluorescence in situ hybridization (FISH) for ERBB2 for
gene amplification, DNA-sequencing of EGFR and ERBB2 genes from DNA extracted from
pretreatment biopsy material for mutation screening, gene expression profiling on
pre-treatment biopsy material to identify predictors of response to treatment, apoptosis
(TUNEL assay), Ki67 (nuclear proliferation antigen)IV. To determine the utility of the
comprehensive geriatric assessment, in predicting tolerance to treatment in patients >= 65
years included in this trial. OUTLINE: Patients receive erlotinib hydrochloride orally or
via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of
radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once
daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease
progression or unacceptable toxicity.After completion of study treatment, patients are
followed up at 6 months, every 3 months for 2 years, and then every 6 months for 2 years.