OBJECTIVES:

• Determine the feasibility of a structured pilot study that includes pharmacokinetic sampling in patients age 75 and over or age 50 and under with metastatic or unresectable head and neck cancer or non-small lung cancer treated with gefitinib.
• Compare, preliminarily, the peak concentration level, elimination half-life, and steady state level of gefitinib between patients in these two age groups.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to age (75 years and over vs 50 years and under)

Patients receive oral gefitinib on day 1 and then daily beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days and then for up to 3 years after study registration.

PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer

  • Metastatic or unresectable disease for which standard curative or palliative treatment measures do not exist or are no longer effective
• Brain metastases allowed provided the metastases have been treated and are stable

PATIENT CHARACTERISTICS:

Age

• 50 and under or 75 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• Bilirubin normal
• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)

Renal

• Creatinine normal

Cardiovascular

• No severe unstable or uncompensated cardiac disease

Pulmonary

• No severe unstable or uncompensated respiratory disease

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other concurrent severe or uncontrolled systemic disease or infection
• Able to swallow oral medication in pill form

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior epidermal growth factor receptor inhibitors
• No concurrent immunotherapy for the malignancy

Chemotherapy

• Prior chemotherapy allowed
• No concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No concurrent agents that induce CYP3A4, including the following:

  • Nafcillin
  • Rifampin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Oxcarbazepine
  • Fosphenytoin
  • Primidone
  • Hypericum perforatum (St. John's wort)
  • Rifabutin
  • Rifapentine
  • Modafinil
• No concurrent retroviral therapies for HIV-positive patients
• Recovered from prior therapy