Stereotactic Radiosurgery and Erlotinib in Treating Patients With Non-Small Cell Lung Cancer and Brain Metastases

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:
• •* Fewer than 5 intraparenchymal brain metastases by gadolinium-enhanced MRI meeting the following criteria:
• •* Maximum diameter ≤ 4.0 cm
• •* If multiple lesions are present and one lesion is \> 3.0 cm, the remaining lesions must be ≤ 3.0 cm in maximum diameter
• •* No metastases within 3 mm of the optic nerve or optic chiasm such that some portion of the optic nerve or chiasm would receive \> 9 Gy from radiosurgery
• •* No metastases in the brainstem, midbrain, pons, or medulla
• •No prior complete resection of a single brain metastasis or of all known brain metastases
• •* Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter
• •No clinical or radiographic evidence of unstable systemic progression (other than the study lesion\[s\]) within the past month
• •* Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease
• •Isolated brain metastases with stable systemic disease allowed
• •No leptomeningeal metastases by MRI and/or positive cerebrospinal fluid cytology
• •PATIENT CHARACTERISTICS:
• •Karnofsky performance status 60-100%
• •Life expectancy ≥ 3 months
• •ANC \> 1,000/mm³
• •Platelet count \> 100,000/mm³
• •Hemoglobin \> 10 g/dL
• •PT and PTT normal
• •AST \< 2 times upper limit of normal (ULN)
• •Alkaline phosphatase \< 2 times ULN
• •Total bilirubin \< 2 times ULN
• •Lactic dehydrogenase \< 2 times ULN
• •Serum creatinine \< 1.5 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy
• •Neurologic function status 0-2
• •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride
• •No contraindication to MRI (e.g., cardiac pacemaker)
• •No absolute contraindication to lumbar puncture
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Prior systemic therapy allowed
• •No prior cranial radiotherapy
• •* Prior radiotherapy to noncranial sites allowed
• •More than 1 week since prior intrathecal chemotherapy or prior treatment of leptomeningeal carcinoma
• •No concurrent systemic therapy
• •* Prior or current erlotinib hydrochloride for treatment of systemic disease allowed provided systemic disease has not progressed while on erlotinib hydrochloride
• •No concurrent enzyme-inducing anticonvulsant
• •* If patients are on an enzyme-inducing anticonvulsant (e.g., phenytoin, carbamazepine, or phenobarbital), the agent must be converted to a nonenzyme-inducing anticonvulsant before or at the start of erlotinib hydrochloride treatment
• •No concurrent CYP3A4 inhibitors or inducers (e.g., Hypericum perforatum \[St. John wort\] or ketoconazole)
• •No other concurrent investigational therapy