RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib followed by surgery and/or radiation therapy may be an effective treatment for squamous cell skin cancer.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery and/or radiation therapy for locally advanced or recurrent squamous cell skin cancer.

OBJECTIVES:

Primary

• Determine the early (during induction therapy) progression rate in patients with locally advanced or recurrent squamous cell carcinoma of the skin treated with induction therapy comprising gefitinib followed by surgery and/or radiotherapy and gefitinib.
• Determine the feasibility of these regimens in these patients.
• Determine the toxic effects of these regimens in these patients.

Secondary

• Determine the clinical response in patients treated with these regimens.
• Determine the frequency and timing of local and distant failures in patients treated with these regimens.

OUTLINE: Patients are stratified according to initial tumor resectability (yes vs no).

• Induction therapy: Patients receive oral gefitinib once daily on days 1-30. Treatment repeats every 30 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of induction therapy, patients are evaluated for clinical response. Patients with stable or responding disease proceed with protocol therapy according to initial tumor resectability as outlined below. Patients with disease progression at any time during induction therapy stop gefitinib and proceed directly to surgery or radiotherapy according to initial tumor resectability as outlined below.
• Stratum 1 (initially resectable tumor): Patients undergo surgical resection of the primary tumor. Patients with lymph node metastases also undergo lymphadenectomy. Within 3-6 weeks after surgery, patients undergo radiotherapy once daily 5 days a week for approximately 7 weeks. Approximately 2 weeks after the completion of radiotherapy, patients with stable or responding disease receive oral gefitinib once daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with progressive disease after surgery and radiotherapy are removed from the study.
• Stratum 2 (initially unresectable tumor): Patients undergo radiotherapy once daily 5 days a week and receive oral gefitinib once daily for approximately 7 weeks. After completion of radiotherapy, patients are evaluated for tumor resectability. Patients with resectable tumor stop gefitinib and undergo surgical resection of the primary tumor. Patients with lymph node metastases also undergo lymphadenectomy. After recovery from surgery, patients with responding or stable disease receive oral gefitinib once daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with unresectable tumor after radiotherapy who continue to have responding or stable disease continue oral gefitinib once daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with progressive disease after radiotherapy and surgery (if indicated) are removed from the study.

After completion of study treatment, patients are followed every 1-2 months for 1 year, every 3 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 23-63 patients (approximately 12-32 per stratum) will be accrued for this study within 2 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the skin
• Locally advanced or recurrent disease
• Measurable disease
• Tumor ≥ 2 cm OR there is muscle, bone, lymph node, or perineural involvement
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• WBC ≥ 3,000/mm^3

Hepatic

• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No psychiatric illness or social situation that would preclude study compliance
• No ongoing or active infection
• No history of allergic reactions to compounds of similar chemical or biological composition to gefitinib
• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy to the proposed radiation field

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy
• No prior radiotherapy to the proposed radiation field

Surgery

• Prior surgical intervention with residual or recurrent disease allowed

Other

• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent CYP3A4 inducing agents, including any of the following:
• Carbamazepine
• Ethosuximide
• Griseofulvin
• Modafinil
• Nafcillin
• Oxcarbazepine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Rifampin
• Rifabutin
• Hypericum perforatum (St. John''''s wort)
• Sulfinpyrazone