Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055978
Status:
COMPLETED
Last Update Posted:
2011-06-20
First Post:
2003-03-06
Brief Title:
Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
Status:
COMPLETED
Status Verified Date:
2011-06
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 Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer
Determine the safety and side effects of this drug in these patients
Determine the quality of life of patients treated with this drug
Determine the role of COX-2-specific inhibitors eg celecoxib on antitumor immunity within the lung microenvironment of these patients
Determine the effects of COX-2 inhibition on angiogenesis in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to presence of preinvasive lesions yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral placebo twice daily for 6 months
Arm II Patients receive oral celecoxib twice daily for 6 months Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed every 6 months during treatment and then annually for up to 4 years
Patients are followed annually for up to 4 years
PROJECTED ACCRUAL A total of 180 patients 90 per treatment arm will be accrued for this study
Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer
Determine the safety and side effects of this drug in these patients
Determine the quality of life of patients treated with this drug
Determine the role of COX-2-specific inhibitors eg celecoxib on antitumor immunity within the lung microenvironment of these patients
Determine the effects of COX-2 inhibition on angiogenesis in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to presence of preinvasive lesions yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral placebo twice daily for 6 months
Arm II Patients receive oral celecoxib twice daily for 6 months Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed every 6 months during treatment and then annually for up to 4 years
Patients are followed annually for up to 4 years
PROJECTED ACCRUAL A total of 180 patients 90 per treatment arm 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 |
|---|---|---|---|
| UCLA-0108074 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016042 |
| U01CA096134 | NIH | None | None |
| P30CA016042 | NIH | None | None |