NCT00096265 - Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

Inclusion Criteria: - Histologically confirmed non-small cell lung cancer - One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria: - Well circumscribed tumor(s) - Maximum diameter ≤ 4.0 cm - If multiple lesions are present and one lesion is at the maximum diameter, the other lesions must not exceed 3.0 cm in maximum diameter - No metastases within 10 mm of the optic apparatus such that a portion of the optic nerve or chiasm would be included in the high-dose stereotactic radiosurgery boost field - No metastases in the brainstem, midbrain, pons, or medulla - No prior complete resection of all known brain metastases - Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter - No clinical or radiographic evidence of progression (other than study lesion[s]) within the past month - Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease - Stable extracranial metastases allowed - No known or pre-existing liver metastases - No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation - Synchronous brain metastases at initial diagnosis allowed - Performance status - Zubrod 0-1 - Hemoglobin ≥ 8 g/dL - Absolute neutrophil count ≥ 1,000/mm^3 - Platelet count ≥ 100,000/mm^3 - AST < 2 times upper limit of normal (ULN) - Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases - Total bilirubin normal - Lactic dehydrogenase < 2 times ULN - Creatinine < 1.5 times ULN - No clinically active interstitial lung disease - Chronic stable asymptomatic radiographic changes allowed - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Neurologic function status 0-2 - No other major medical illness or psychiatric impairment that would preclude study participation - No history of allergic reaction attributed to compounds of similar chemical or biologic composition to erlotinib or temozolomide - No concurrent immunotherapy - No concurrent biologic therapy, excluding growth factors and epoetin alfa - No prior temozolomide or erlotinib - No other concurrent chemotherapy during study radiotherapy - Other concurrent chemotherapy allowed after study radiotherapy, except for the following: - Temozolomide or erlotinib (arm I only) - Erlotinib (arm II only) - Temozolomide (arm III only) - No prior cranial radiotherapy - No concurrent intensity-modulated radiotherapy - Concurrent radiotherapy to painful bone lesions allowed - No concurrent radiotherapy to more than 15% of bone marrow - No other concurrent therapy for brain metastases unless a recurrence is detected - More than 30 days since prior investigational drugs - No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following (for patients randomized to receive erlotinib): - Phenytoin - Carbamazepine - Rifampin - Phenobarbital - Primidone - Oxcarbazepine - No other concurrent investigational drugs - No concurrent Hypericum perforatum (St. John's wort) - No drugs that alter gastric pH (e.g., proton pump inhibitors or H2 antagonists) within 4 hours after erlotinib administration (arm III patients only)