Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073866
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2003-12-10
Brief Title:
Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase III Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor Combining celecoxib with combination chemotherapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer
PURPOSE This phase III trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer
Determine the toxic effects of this regimen in these patients
Determine the response rate of patients treated with this regimen
Determine the progression-free and overall survival of patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Correlate angiogenesis markers intratumoral microvessel density and vascular endothelial growth factor VEGF expression and serum VEGF and cyclooxygenase-2 expression with response and survival in patients treated with this regimen
Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study of docetaxel and irinotecan
Phase I Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8 Patients also receive oral celecoxib twice daily beginning on day 2 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the recommended phase II dose
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 3-70 patients 3-36 for phase I and 16-34 for phase II will be accrued for this study
Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer
Determine the toxic effects of this regimen in these patients
Determine the response rate of patients treated with this regimen
Determine the progression-free and overall survival of patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Correlate angiogenesis markers intratumoral microvessel density and vascular endothelial growth factor VEGF expression and serum VEGF and cyclooxygenase-2 expression with response and survival in patients treated with this regimen
Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study of docetaxel and irinotecan
Phase I Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8 Patients also receive oral celecoxib twice daily beginning on day 2 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the recommended phase II dose
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 3-70 patients 3-36 for phase I and 16-34 for phase II 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 |
|---|---|---|---|
| PHARMACIA-NU-01L2 | None | None | None |
| NU-01L2 | None | None | None |