Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022711
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2001-08-10
Brief Title:
Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Study of Temozolomide SCH 52365 in the Treatment of Patients With Relapsed Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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 relapsed or progressive small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have relapsed or progressive small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of temozolomide in terms of response rate and safety in patients with relapsed or progressive small cell lung cancer
Determine the time to progression and overall survival in patients treated with this drug
Assess quality of life of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to response to prior chemotherapy chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy
Patients receive oral temozolomide once daily on days 1-7 and 15-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to each course of chemotherapy at 30 days after study completion and then every 8 weeks thereafter
Patients are followed at 30 days and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 37-79 patients 14-33 chemosensitive and 23-46 chemoresistant will be accrued for this study
Determine the efficacy of temozolomide in terms of response rate and safety in patients with relapsed or progressive small cell lung cancer
Determine the time to progression and overall survival in patients treated with this drug
Assess quality of life of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to response to prior chemotherapy chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy
Patients receive oral temozolomide once daily on days 1-7 and 15-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to each course of chemotherapy at 30 days after study completion and then every 8 weeks thereafter
Patients are followed at 30 days and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 37-79 patients 14-33 chemosensitive and 23-46 chemoresistant 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-G01-2005 | OTHER | NCI | None |