Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058006
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2003-04-07
Brief Title:
Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
Status:
COMPLETED
Status Verified Date:
2012-06
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 is the use of certain drugs to try to prevent the development or recurrence of cancer The use of celecoxib may be an effective way to prevent the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung cancer
PURPOSE This randomized phase II trial is studying celecoxib to see how well it works compared to that of a placebo in preventing disease recurrence in patients with stage I or stage II head and neck cancer or stage I non-small cell lung cancer
PURPOSE This randomized phase II trial is studying celecoxib to see how well it works compared to that of a placebo in preventing disease recurrence in patients with stage I or stage II head and neck cancer or stage I non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the rate of new malignancies recurrences and second primary tumors in patients with early-stage head and neck cancer or non-small cell lung cancer treated with celecoxib vs placebo
Compare the event-free and overall survival of patients treated with this drug vs placebo
Determine the toxic effects associated with long-term use of celecoxib in these patients
Correlate cyclooxygenase-2 and transforming growth factor TGF-beta expression and CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of patients treated with this drug vs placebo
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to smoking history active smokers including those who quit within 1 year of diagnosis vs former smokers vs non-smokers tumor type lung cancer vs head and neck cancer and stage I vs II for head and neck cancer or T1 vs T2 for lung cancer Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 24 months in the absence of disease recurrence or unacceptable toxicity
Patients are followed every 6 months for 5 years or until disease recurrence
PROJECTED ACCRUAL A total of 121 patients approximately 60 per treatment arm will be accrued for this study
Compare the rate of new malignancies recurrences and second primary tumors in patients with early-stage head and neck cancer or non-small cell lung cancer treated with celecoxib vs placebo
Compare the event-free and overall survival of patients treated with this drug vs placebo
Determine the toxic effects associated with long-term use of celecoxib in these patients
Correlate cyclooxygenase-2 and transforming growth factor TGF-beta expression and CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of patients treated with this drug vs placebo
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to smoking history active smokers including those who quit within 1 year of diagnosis vs former smokers vs non-smokers tumor type lung cancer vs head and neck cancer and stage I vs II for head and neck cancer or T1 vs T2 for lung cancer Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 24 months in the absence of disease recurrence or unacceptable toxicity
Patients are followed every 6 months for 5 years or until disease recurrence
PROJECTED ACCRUAL A total of 121 patients approximately 60 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 |
|---|---|---|---|
| PHARMACIA-NU-02V2 | None | None | None |
| NU-02V2 | None | None | None |