A Phase II Study Of Temozolomide (SCH 52365) In Subjects With Brain Metastasis From Nonsmall Cell Lung Cancer
- Compare the time to symptomatic neurologic progression, in terms of worsening in 1 or
more of 6 clinical categories including headaches, focal weakness, mentation and/or
communication, visual changes, coordination, and new cranial neuropathy, in patients
with brain metastases from non-small cell lung cancer treated with whole brain
radiotherapy with or without temozolomide.
- Compare the time to progression in patients treated with these regimens.
- Compare the overall response rate and overall survival in patients treated with these
- Compare changes in disease-related symptoms in patients treated with these regimens.
- Compare the effect of these regimens on steroid usage and seizure frequency in these
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior chemotherapy (yes vs no) and recursive partitioning
analysis classification (1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment
repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients also receive whole brain radiotherapy once daily 5 days
a week for 2 weeks beginning on day 1.
- Arm II: Patients receive oral placebo and radiotherapy as in arm I. Quality of life is
assessed on day 1 of each course, on day 30 after the last course, and then every 8
weeks until disease progression.
Patients are followed at 30 days and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Lauren E. Abrey, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|