Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088959
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2004-08-04
Brief Title:
Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Erlotinib and Celecoxib in Former Smokers With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-04
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:
This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating former smokers with stage IIIB stage IV recurrent or progressive non-small cell lung cancer Celecoxib and erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVE
I To estimate the clinical toxicity and tolerability of erlotinib combined with celecoxib in patients with advanced non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To estimate the tumor response rate of erlotinib combined with celecoxib in patients with advanced NSCLC
II To estimate the dose of celecoxib that results in maximal induction of apoptosis maximal inhibition of prostaglandin E2 PGE2 in bronchoalveolar BAL fluid and maximal inhibition of bronchial cell proliferation when combined with erlotinib
III To estimate the effect of erlotinib and the combination of erlotinib and celecoxib on bronchial expression of COX-2
IV To estimate the effect of erlotinib and the combination of erlotinib and celecoxib on autophosphorylation of epidermal growth factor receptor EGFR in skin and endobronchial biopsies
V To estimate the degree of correlation of autophosphorylation of EGFR in skin and endobronchial samples
TERTIARY OBJECTIVES
I To estimate the effect of the combination of erlotinib and COX-2 inhibitor celecoxib on the frequency of fractional allelic loss FAL in endobronchial biopsies metaplasia and dysplasia in endobronchial biopsies and endobronchial proliferation
OUTLINE This is an open-label dose-escalation study of celecoxib
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of celecoxib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 6 additional patients are treated at the MTD
Patients are followed at 4 weeks
I To estimate the clinical toxicity and tolerability of erlotinib combined with celecoxib in patients with advanced non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To estimate the tumor response rate of erlotinib combined with celecoxib in patients with advanced NSCLC
II To estimate the dose of celecoxib that results in maximal induction of apoptosis maximal inhibition of prostaglandin E2 PGE2 in bronchoalveolar BAL fluid and maximal inhibition of bronchial cell proliferation when combined with erlotinib
III To estimate the effect of erlotinib and the combination of erlotinib and celecoxib on bronchial expression of COX-2
IV To estimate the effect of erlotinib and the combination of erlotinib and celecoxib on autophosphorylation of epidermal growth factor receptor EGFR in skin and endobronchial biopsies
V To estimate the degree of correlation of autophosphorylation of EGFR in skin and endobronchial samples
TERTIARY OBJECTIVES
I To estimate the effect of the combination of erlotinib and COX-2 inhibitor celecoxib on the frequency of fractional allelic loss FAL in endobronchial biopsies metaplasia and dysplasia in endobronchial biopsies and endobronchial proliferation
OUTLINE This is an open-label dose-escalation study of celecoxib
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of celecoxib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 6 additional patients are treated at the MTD
Patients are followed at 4 weeks
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 |
|---|---|---|---|
| U01CA096123 | NIH | None | httpsreporternihgovquickSearchU01CA096123 |
| 4939-04-6R2 | None | None | None |
| DUMC-4939-03-6R0 | None | None | None |
| VAMC-DURHAM-00813 | None | None | None |
| DUMC-GCRC-911 | None | None | None |
| CDR0000377689 | None | None | None |
| DUMC-4939-04-6R2 | None | None | None |