Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer

Inclusion criteria

• Either bronchioloalveolar cell carcinoma or a variant thereof after review
• Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or recurrent/medically inoperable disease
• Measurable or evaluable indicator lesions
• No prior or one chemotherapy regimen for NSCLC
• Three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area
• Karnofsky performance status > or = to 80% OR ECOG performance status ≤ or = to 1
• Life expectancy > or = to 8 weeks
• Adequate hematologic, renal and/or hepatic function: WBC > or = to 3,000/ul, hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin < or = to 1.0 mg/dl, AST < than or = to 2.5 X UNL, creatinine < or = to 1.5 mg/dl or Clcr > or = to 55ml/min.
• Effective contraception

Exclusion criteria

• Prior exposure to OSI-774 or other treatments targeting the HER family axis (e.g.-trastuzumab, ZD1839, C225, etc.)
• Two or more prior chemotherapy regimens
• Concurrent active cancer
• Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids)
• Pregnant or lactating women
• Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
• Prior systemic cytotoxic chemotherapy for other malignant disease
• Significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent MI, unstable angina, active infection, uncontrolled hypertension).