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

Inclusion Criteria

• •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