Lung Cancer Clinical Trial
Official title:
Phase II Quality of Life Study of Stereotactic RadioSurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer
RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain
function (the ability to think, learn, remember, and judge) in patients with non-small cell
lung cancer and brain metastases. A study that evaluates brain function may help doctors
plan the best treatment.
PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and
erlotinib on brain function in patients with non-small cell lung cancer and brain
metastases.
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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