Temozolomide in the Treatment of Advanced Non-Small Cell Lung Carcinoma: Phase II Evaluation in Previously Treated and Chemo-Naive Patients
OBJECTIVES: I. Determine the objective response rate to temozolomide in previously treated
(closed to accrual 8/01) and chemotherapy-naive patients with advanced non-small cell lung
cancer. II. Determine the freedom from progression median, and 1-year and 2-year survival
rates in these patients on this regimen.
OUTLINE: Patients are stratified by prior chemotherapy (yes (closed to accrual 8/01) vs no).
Patients receive oral temozolomide daily for 42 days. Treatment repeats every 8 weeks for up
to 2 years in the absence of disease progression or unacceptable toxicity. Patients are
followed every 2 months.
PROJECTED ACCRUAL: Up to 66 patients (33 per stratum (previously treated stratum closed to
accrual 8/01)) will be accrued for this study within 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine objective response rate in both previously treated and untreated patients.
Corey J. Langer, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Waukesha Memorial Hospital||Waukesha, Wisconsin 53188|