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

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary squamous cell cancer of the head and neck that is incurable by surgery or radiotherapy * Stratum I: * Failed surgery and/or radiotherapy and received no prior systemic chemotherapy for recurrent disease OR * Recurrent disease at least 6 months after prior multimodal primary therapy including neoadjuvant or concurrent chemotherapy OR * Metastatic disease at initial diagnosis and received no prior chemotherapy * Stratum II: * No more than 1 prior chemotherapy regimen for recurrent disease OR * Recurrent disease within 6 months after prior primary therapy that included chemotherapy * Measurable disease * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Clear clinical evidence of progression or biopsy-proven residual cancer required if only site of measurable disease is in a previously irradiated field * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal (no greater than 1.5 times upper limit of normal \[ULN\] if liver metastases present) * AST/ALT no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No prior allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior therapy with agents that target epidermal growth factor receptors Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * No concurrent tamoxifen Radiotherapy: * Prior radiotherapy as primary or secondary treatment allowed * At least 4 weeks since prior radiotherapy and recovered Surgery: * Prior surgery as primary or secondary treatment allowed * At least 4 weeks since prior major surgery Other: * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV * No concurrent 3A4 inhibitors (e.g., ketoconazole, erythromycin, verapamil) * No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone, chloroquine)