Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:
• •* Stage IIIB (unresectable, with malignant pleural or pericardial effusion)
• •* Stage IV disease
• •* Recurrent disease
• •Measurable or evaluable indicator lesions
• •Progressive disease after receiving ≥ 1 prior chemotherapy regimen that included cisplatin or carboplatin and docetaxel
• •No uncontrolled brain or leptomeningeal metastases
• •* Must not require concurrent glucocorticoids for control of metastases
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Karnofsky 70-100% OR
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •WBC ≥ 3,000/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9.0 g/dL
• •Hepatic
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST ≤ 2.5 times ULN
• •Renal
• •Creatinine ≤ 1.5 times ULN OR
• •Creatinine clearance ≥ 60 mL/min
• •Cardiovascular
• •No congestive heart failure
• •No New York Heart Association class III or IV heart disease
• •No unstable angina
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No severe infection
• •No severe malnutrition
• •No other serious medical illness
• •No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma of the cervix
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No concurrent biologic therapy
• •No concurrent immunotherapy
• •Chemotherapy
• •See Disease Characteristics
• •No prior conventional chemotherapy for metastatic or recurrent NSCLC (phase II only)
• •At least 4 weeks since prior chemotherapy
• •No other concurrent chemotherapy
• •Endocrine therapy
• •See Disease Characteristics
• •No concurrent oral steroids for management of skin toxicity
• •Radiotherapy
• •At least 4 weeks since prior radiotherapy
• •No concurrent radiotherapy
• •Surgery
• •At least 4 weeks since prior major surgery
• •No concurrent surgery for an identifiable lesion
• •Other
• •Recovered from all prior therapy
• •No prior gefitinib, erlotinib, or other epidermal growth factor tyrosine kinase inhibitor
• •No concurrent cytotoxic therapy (e.g., methotrexate for rheumatoid arthritis)
• •No other concurrent oncolytic agents