Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072072
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2003-11-04
Brief Title:
Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of A COX-2 Inhibitor Celecoxib In Combination With An EGFR Inhibitor OSI-774 In Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2006-01
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 Celecoxib may stop the growth of cancer by stopping blood flow to the tumor Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Combining celecoxib with erlotinib may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer
Determine the toxicity profile of this regimen in these patients
Secondary
Determine the clinical activity of this regimen in terms of reduction in tumor burden in these patients
Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen
OUTLINE This is a nonrandomized dose-escalation study of celecoxib
Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28 Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may continue treatment beyond 2 courses at the investigators discretion
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose MTD and biologically active dose BAD are determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 21-27 patients will be accrued for this study
Primary
Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer
Determine the toxicity profile of this regimen in these patients
Secondary
Determine the clinical activity of this regimen in terms of reduction in tumor burden in these patients
Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen
OUTLINE This is a nonrandomized dose-escalation study of celecoxib
Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28 Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may continue treatment beyond 2 courses at the investigators discretion
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose MTD and biologically active dose BAD are determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 21-27 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0306083 | None | None | None |