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