Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Pathologically confirmed non-small cell lung cancer (NSCLC)
• •* No squamous cell histology
• •Stage IIIB (with pleural effusion) or stage IV disease
• •Must meet ≥ 1 of the following criteria:
• •* Female
• •* Adenocarcinoma tumor histology
• •* No history of smoking, defined as smoking \< 100 cigarettes (5 standard packs of cigarettes) in a lifetime, \< 20 oz of pipe tobacco in a lifetime, OR \< 100 cigars in a lifetime
• •* Asian/Pacific Rim ethnicity, defined as Japanese, Chinese, Korean, or other Asian/Pacific Rim ethnicity
• •Must have activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene
• •Measurable disease
• •No symptomatic or newly diagnosed CNS metastases that have not been definitively treated with radiotherapy and/or surgery
• •* History of CNS metastases or cord compression allowed if definitively treated and clinically stable
• •PATIENT CHARACTERISTICS:
• •See Disease Characteristics
• •ECOG performance status 0-2
• •Life expectancy ≥ 12 weeks
• •Absolute neutrophil count ≥ 2,000/mm³
• •Platelet count ≥ 100,000/mm³
• •Bilirubin ≤ 1.25 times upper limit of normal (ULN)
• •ALT and AST ≤ 2.5 times ULN (5 times ULN if liver has tumor involvement)
• •Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No known severe hypersensitivity to gefitinib or any other component of gefitinib tablets
• •No evidence of clinically active interstitial lung disease
• •* Patients with chronic, stable radiographic changes who are asymptomatic are eligible
• •No other concurrent malignancy or malignancy diagnosed within the past 5 years except for basal cell carcinoma of the skin or cervical cancer in situ
• •No concurrent severe or uncontrolled systemic disorder
• •No evidence of any other significant clinical disorder or laboratory finding that, in the opinion of the investigator, would preclude study participation
• •Able to tolerate protocol treatment, in the opinion of the investigator
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •No prior systemic chemotherapy, biological therapy, immunotherapy, or hormonal therapy for NSCLC, including adjuvant and neoadjuvant treatment
• •No prior radiotherapy to the target lesion
• •* Prior radiotherapy to bony disease or CNS disease allowed
• •At least 2 weeks since prior radiotherapy and recovered
• •More than 30 days since prior non-FDA approved or investigational agents
• •No prior EGFR antagonists
• •At least 2 weeks since prior and no concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort)
• •No concurrent chemotherapy, immunotherapy, hormonal therapy, nonpalliative radiotherapy, surgery for cancer, or other experimental medications
• •No other concurrent specific antitumor therapy