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

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)