Phase II Study of Stereotactic Radiosurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-Small Cell Lung Cancer
- Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib
hydrochloride on cognitive function in patients with non-small cell lung cancer and
- 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
- 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
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
Molly Gabel, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration