Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005037
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2000-04-06
Brief Title:
Temozolomide in Treating Patients With Stage IIIB Stage IV or Recurrent Non-small Cell Lung Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Temozolomide in the Treatment of Advanced Non-Small Cell Lung Carcinoma Phase II Evaluation in Previously Treated and Chemo-Naive Patients
Status:
COMPLETED
Status Verified Date:
2014-05
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 stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate to temozolomide in previously treated closed to accrual 801 and chemotherapy-naive patients with advanced non-small cell lung cancer II Determine the freedom from progression median and 1-year and 2-year survival rates in these patients on this regimen
OUTLINE Patients are stratified by prior chemotherapy yes closed to accrual 801 vs no Patients receive oral temozolomide daily for 42 days Treatment repeats every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity Patients are followed every 2 months
PROJECTED ACCRUAL Up to 66 patients 33 per stratum previously treated stratum closed to accrual 801 will be accrued for this study within 2 years
OUTLINE Patients are stratified by prior chemotherapy yes closed to accrual 801 vs no Patients receive oral temozolomide daily for 42 days Treatment repeats every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity Patients are followed every 2 months
PROJECTED ACCRUAL Up to 66 patients 33 per stratum previously treated stratum closed to accrual 801 will be accrued for this study within 2 years
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-G00-1712 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-99032 | None | None | None |