High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations

Inclusion Criteria: * Histologically or cytologically proven diagnosis of non-small cell lung cancer of any histologic subtype * High likelihood of gefitinib sensitivity, as evidenced by one or more of the following: previous complete or partial response to treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor, erlotinib, or gefitinib; known somatic mutation of the EGFR tyrosine kinase * Recurrent or persistent disease as manifested by carcinomatous meningitis * ECOG PS 0-3 * Age 18 years or older * Greater than 2 weeks since prior radiation therapy * Greater than 3 weeks since prior major surgery * Adequate hematologic, renal, and/or hepatic function * Coagulation parameters: international normalized ratio(INR)less than or equal to 1.5 and an activated thromboplastin time \< 50 seconds Exclusion Criteria: * Previous Grade 4 toxicity on gefitinib or erlotinib leading to dose reduction or interruption * Uncontrolled brain metastases, or brain metastases associated with mass effect that would contraindicate lumbar puncture * Any other malignancy within the past five years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin * Dysphagia * Active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption * Incomplete healing from previous oncologic or other major surgery * Any pre-existing severe or unstable medical condition * Any condition requiring concurrent and ongoing use of anticoagulation * Inability to undergo collection of CSF, either by repeated lumbar puncture or placement of an Omaya reservoir * Pregnant or breastfeeding * Concurrent intrathecal drug administration or radiotherapy * Concurrent systemic chemotherapy or investigational agent * Anticoagulant except aspirin or heparin flushes * Enzyme-inducing anti-epileptic drug * CYP3A4 inhibitors