Radiation Therapy Combined With Either Gefitinib or Temozolomide in Pats With NSCLC and Brain Metastases

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed non-small cell lung cancer AND newly diagnosed brain metastases meeting 1 of the following criteria:
• * Multiple brain metastases
• * Single brain metastasis not amenable to potentially curative treatment
• No advanced extracranial disease severely compromising vital functions and performance
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• WHO 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Hemoglobin \> 10 g/dL
• Absolute neutrophil count \> 1,500/mm\^3
• Platelet count \> 100,000/mm\^3
• Hepatic
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of documented bone metastases)
• No unstable or uncompensated hepatic disease that would preclude study participation
• Renal
• Creatinine clearance ≥ 40 mL/min
• No unstable or uncompensated renal disease that would preclude study participation
• Cardiovascular
• No myocardial infarction within the past 3 months
• No unstable or uncompensated cardiac disease that would preclude study participation
• Pulmonary
• No clinically active interstitial lung disease
• * Patients with chronic stable radiographic changes who are asymptomatic eligible
• No other unstable or uncompensated respiratory disease that would preclude study participation
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after completion of study treatment
• No nausea, vomiting, inability to swallow whole tablets/capsules, or malabsorption syndrome that would preclude oral medication ingestion or absorption
• No psychiatric disorder that would preclude giving informed consent or study compliance
• No active infection
• No uncontrolled diabetes mellitus
• No other medical condition that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• No prior temozolomide
• Endocrine therapy
• Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 4 days before study entry
• Radiotherapy
• No prior brain irradiation
• Surgery
• Not specified
• Other
• No prior gefitinib or erlotinib
• More than 30 days since prior investigational clinical trial participation
• No other concurrent experimental drugs
• No other concurrent anticancer therapy
• No concurrent treatment with any of the following:
• * Phenytoin
• * Carbamazepine
• * Rifampin
• * Barbiturates
• * Hypericum perforatum (St. John's wort)
• * Other enzyme-inducing anti-epileptic drugs or tuberculostatic treatments
• * Any drug that contraindicates administration with study drugs