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

Inclusion Criteria

• •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)