Finding studies
Finding studies
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Lead
University of Medicine and Dentistry of New Jersey
With
OBJECTIVES: Primary * Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib hydrochloride on cognitive function in patients with non-small cell lung cancer and brain metastases. Secondary * Determine the feasibility and safety of this regimen, in terms of tumor response, time to tumor progression in brain, survival, physical functioning, and quality of life, in these patients. * Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation in these patients. OUTLINE: This is a multicenter study. Patients undergo stereotactic radiosurgery on day -7. Patients receive oral temozolomide once daily on days 1-5 and oral erlotinib hydrochloride once daily on days 1-23. Treatment with temozolomide and erlotinib hydrochloride repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo cognitive function evaluation as measured by Mini-Mental Status Exam administration and scoring; quality of life assessment as measured by Functional Assessment of Cancer Therapy subscale; and physical functioning assessment as measured by Katz index of activities of daily living and Karnofsky performance status at baseline and then every 8 weeks during study treatment. Tumor tissue is examined by O6-methylguanine-DNA methyltransferase (MGMT gene) promotor methylation. After completion of study therapy, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
