A Phase II Study Of Temozolomide In The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the efficacy of temozolomide in terms of complete and partial
response rates in patients with metastatic non-small cell lung cancer. II. Determine the
safety of this regimen in these patients. III. Determine the time to progression and overall
survival in patients treated with this regimen. IV. Determine the quality of life and
changes in disease-related symptoms in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive oral temozolomide daily on days 1-7
and 15-21. Treatment continues every 4 weeks for a maximum of 6 months in the absence of
disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every
4 weeks during study, and then every 8 weeks after study. Patients are followed for 1 month
and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-60 patients will be accrued for this study.
Primary Purpose: Treatment
Afshin Dowlati, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|