Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• * Metastatic or unresectable disease
• Measurable disease
• * At least 1 lesion at least 2.0 cm
• * Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy
• No meningeal carcinomatosis
• No untreated brain metastases
• * Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy
• No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy)
• PATIENT CHARACTERISTICS:
• Age
• 65 and over
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 10.0 g/dL
• Hepatic
• Bilirubin no greater than 2.0 mg/dL
• No uncontrolled hepatic disease
• Renal
• Creatinine no greater than 2 times upper limit of normal
• No uncontrolled renal disease
• Cardiovascular
• No uncontrolled cardiac disease
• Pulmonary
• No clinically active interstitial lung disease
• * Asymptomatic, chronic stable radiographic changes allowed
• No uncontrolled respiratory disease
• Other
• Fertile patients must use effective contraception
• Able and willing to complete questionnaires alone or with assistance
• No known hypersensitivity to gefitinib or any of its excipients
• No active infection within the past 2 weeks
• No other prior malignancy within the past 5 years except basal cell skin cancer
• No grade 2 or greater peripheral neuropathy (CTC v2.0)
• No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)
• No dysphagia or inability to swallow intact capsules
• No significant medical condition that would preclude study treatment or follow-up
• No severe or uncontrolled systemic disease
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• See Disease Characteristics
• No prior chemotherapy for metastatic NSCLC
• Endocrine therapy
• Concurrent steroids allowed provided the dose is not changed
• Radiotherapy
• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered
• No prior radiotherapy to more than 25% of marrow-containing skeleton
• No concurrent radiotherapy (including palliative)
• Surgery
• See Disease Characteristics
• At least 3 weeks since prior major surgery
• No surgery within 7 days after study participation
• Other
• More than 30 days since prior non-FDA approved investigational drugs
• No concurrent oral retinoids
• No concurrent CYP3A4-inducing agents, including the following:
• * Carbamazepine
• * Oxcarbazepine
• * Modafinil
• * Ethosuximide
• * Griseofulvin
• * Nafcillin
• * Phenobarbital
• * Phenylbutazone
• * Phenytoin
• * Primidone
• * Rifampin
• * Hypericum perforatum (St. John's wort)
• * Barbiturates
• * Sulfinpyrazone
• No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)
• No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration
• No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin