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

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