Temozolomide in Treating Patients With Metastatic Non-small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have metastatic non-small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study Of Temozolomide In The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer|
|Study Start Date:||July 2000|
|Study Completion Date:||September 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
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.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Afshin Dowlati, MD||Case Comprehensive Cancer Center|