Erlotinib in Treating Patients With Metastatic and/or Recurrent Head and Neck Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck
• Metastatic and/or locally recurrent disease
• No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations, as well as tumors of the parotid gland
• WHO Type I squamous cell carcinoma of the nasopharynx are allowed
• Incurable with surgery or radiotherapy
• Measurable disease, defined as ≥ 1 target lesion ≥ 20 mm OR ≥ 10 mm on spiral CT scan
• If the only site of measurable disease is in a previously irradiated area, the patient must have documented progressive disease by tomography or biopsy-proven residual carcinoma
• No symptomatic brain metastases that are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life-threatening, or have required radiotherapy within the last 14 days

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Predicted life expectancy ≥ 12 weeks
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and/or ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must practice effective contraceptive measures
• No other prior malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• No active or uncontrolled infection or other serious illnesses or medical conditions
• No history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than two prior chemotherapy regimens for locally recurrent and/or metastatic disease
• Prior induction chemotherapy or chemoradiotherapy with curative intent for local disease allowed provided patient has received no more than two prior chemotherapy regimens for recurrent disease
• Prior therapy must have been completed a minimum of 14 days prior to study AND patient has recovered
• No prior molecular-directed therapies, such as tyrosine kinase inhibitors and/or monoclonal antibodies
• At least 14 days must have elapsed between the end of radiotherapy and study registration and recovered
• At least 14 days since prior surgery AND wound healing has occurred
• At least 7 days since prior herbal extracts and tinctures with CYP3A inhibitory activity, including any of the following:
• Hydrastis canadensis (goldenseal)
• Uncaria tomentosa (cat's claw)
• Echinacea angustifolia roots
• Trifolium pratense (wild cherry)
• Matricaria chamomilla (chamomile)
• Glycyrrhiza glabra (licorice)
• Dillapiol
• Naringenin
• No other concurrent anticancer therapy or other investigational agents
• No concurrent administration of any of the following:
• Phenytoin
• Carbamazepine
• Rifampicin
• Barbiturates
• Hypericum perforatum (St. John's wort)
• CYP3A inhibitors (e.g., itraconazole)