Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:26 PM
Study NCT ID:
NCT00088959
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2004-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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:
False
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?: