Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed locally advanced squamous cell carcinoma of the head and neck
• * Stage III or IV disease
• * No distant metastatic disease
• Measurable disease (according to RECIST)
• No salivary gland and paranasal sinus squamous cell carcinoma
• No known brain metastases or direct cerebral invasion by tumor
• * Intracranial extension (without cerebral involvement) may be allowed
• PATIENT CHARACTERISTICS:
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy \> 12 weeks
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥10 g/dL
• Total bilirubin normal
• Alkaline phosphatase AND AST and ALT meeting the following criteria:
• * Alkaline phosphatase normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
• * Alkaline phosphatase ≤ 2.5 times ULN AND AST and ALT ≤ 2.5 times ULN
• * Alkaline phosphatase ≤ 5 times ULN AND AST and ALT normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• No clinically significant heart disease including any of the following:
• * NYHA class III or IV heart disease
• * Significant arrhythmias requiring medication
• * Symptomatic coronary artery disease
• * Myocardial infarction within the previous six months
• * Second- or third-degree heart block or bundle-branch block
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride or docetaxel, including other drugs formulated with polysorbate 80
• No pre-existing peripheral neuropathy ≥ grade 2
• No uncontrolled concurrent illness including, but not limited to, any of the following:
• * Ongoing or active infection
• * Symptomatic congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia
• * Psychiatric illness/social situations that would preclude compliance with study requirements
• No HIV positivity
• No other prior malignancy except for any of the following:
• * Squamous cell or basal cell carcinoma of the skin
• * Carcinoma in situ of the cervix
• * Cancer that was treated more than 5 years ago and the patient has remained disease-free
• Not poorly compliant
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy, radiotherapy, or investigational antitumor drug
• No other concurrent investigational agents