Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006877
Status:
COMPLETED
Last Update Posted:
2014-01-08
First Post:
2000-12-06
Brief Title:
Temozolomide in Treating Patients With Metastatic Non-small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study Of Temozolomide In The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2001-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have metastatic non-small cell lung cancer
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1876 | None | None | None |
| CWRU-SCH-1500 | None | None | None |
| CWRU-050002 | None | None | None |
| SPRI-P00349 | None | None | None |