Safety Study of Radiotherapy and Concurrent Erlotinib (Tarceva®) for Brain Metastases From a Non-Small Cell Lung Cancer

Inclusion Criteria

• •Histological or cytological confirmation of non-small cell lung cancer (NSCLC)
• •Diagnosis of brain metastases on a contrast-enhanced CT scan or Gadolinium-enhanced MRI
• •Patients who are not candidates for surgery or stereotactic radiosurgery
• •RPA Class 1 or 2 (Karnofsky performance status \> 70)
• •Age \> 18 years
• •No previous radiotherapy, surgery or chemotherapy for brain metastases
• •Patients must be able to take oral medication.
• •Patients should not have any unstable systemic disease except lung cancer (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
• •Granulocyte count \> 1.5 x 109/L and platelet count \> 100 x 109/L OK
• •Serum bilirubin must be \< 1.5 upper limit of normal (ULN).
• •AST and/or ALT \< 2 x ULN (or \< 5 x ULN if clearly attributable to liver metastasis)
• •Serum creatinine \< 1.5 ULN or creatinine clearance \> 60 ml/min
• •Patients with reproductive potential must use effective contraception. For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy.
• •Able to comply with study and follow-up procedures
• •Written informed consent.