Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)
• •* Stage IIIB (malignant pleural or pericardial effusion) disease
• •* Stage IV disease
• •* Recurrent and/or medically inoperable disease
• •Measurable or evaluable indicator lesions
• •No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)
• •PATIENT CHARACTERISTICS:
• •ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
• •Life expectancy ≥ 8 weeks
• •WBC ≥ 3,000/mm³
• •Hemoglobin ≥ 9.0 g/dL
• •Platelet count ≥ 100,000/mm³
• •Bilirubin ≤ 1.0 mg/dL
• •AST ≤ 2 times upper limit of normal
• •Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No significant medical history or unstable medical condition, including any of the following:
• •* Unstable systemic disease
• •* Congestive heart failure
• •* Recent myocardial infarction
• •* Unstable angina
• •* Active infection
• •* Uncontrolled hypertension
• •No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
• •At least 3 weeks since prior chemotherapy
• •No more than 1 prior chemotherapy regimen for NSCLC
• •No prior systemic cytotoxic chemotherapy for other malignant diseases
• •No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab \[Herceptin®\], or gefitinib)
• •No concurrent radiotherapy or chemotherapy