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

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