NCT00385398

QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.
DRUG	temozolomide	Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.
RADIATION	stereotactic radiosurgery	Stereotactic radiosurgery will be performed prior to chemotherapy.

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-10-09
• Last updated: 2013-09-02