Temozolomide in Treating Patients With Metastatic Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00006877|
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : January 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: temozolomide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||September 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006877
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Afshin Dowlati, MD||Case Comprehensive Cancer Center|