Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101335
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2005-01-07
Brief Title:
Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase IIb Cancer Prevention Trial of Celecoxib a Selective COX-2 Inhibitor in Oral Leukoplakia
Status:
COMPLETED
Status Verified Date:
2013-07
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 is the use of certain drugs to keep cancer from forming growing or coming back The use of celecoxib may prevent or treat head and neck cancer
PURPOSE This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in patients with oral leukoplakia
PURPOSE This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in patients with oral leukoplakia
Detailed Description:
OBJECTIVES
Primary
Compare the clinical efficacy of celecoxib vs placebo in terms of inducing regression of oral leukoplakia lesions in patients with hyperplastic or dysplastic oral leukoplakia
Secondary
Determine the effect of this drug in modulating multiple intermediate biomarkers eg COX-2 PPARĪ³ or PPARĪ“ in normal and hyperplastic or dysplastic oral epithelia of these patients
Determine the safety of this drug in these patients
Determine the cost-effectiveness of this drug as a chemopreventative agent in these patients
OUTLINE This is a randomized double-blind placebo-controlled cross-over study Patients are stratified according to the pathology of the leukoplakia lesion dysplasia vs hyperplasia Patients are randomized to 1 of 2 arms
Arm I Patients receive oral celecoxib twice daily for 3 months
Arm II Patients receive oral placebo twice daily for 3 months All patients undergo biopsy Patients then cross-over to the opposite treatment arm for 3 months
In both arms treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 27-60 patients 18-40 for study drug 9-20 for placebo before cross-over will be accrued for this study
Primary
Compare the clinical efficacy of celecoxib vs placebo in terms of inducing regression of oral leukoplakia lesions in patients with hyperplastic or dysplastic oral leukoplakia
Secondary
Determine the effect of this drug in modulating multiple intermediate biomarkers eg COX-2 PPARĪ³ or PPARĪ“ in normal and hyperplastic or dysplastic oral epithelia of these patients
Determine the safety of this drug in these patients
Determine the cost-effectiveness of this drug as a chemopreventative agent in these patients
OUTLINE This is a randomized double-blind placebo-controlled cross-over study Patients are stratified according to the pathology of the leukoplakia lesion dysplasia vs hyperplasia Patients are randomized to 1 of 2 arms
Arm I Patients receive oral celecoxib twice daily for 3 months
Arm II Patients receive oral placebo twice daily for 3 months All patients undergo biopsy Patients then cross-over to the opposite treatment arm for 3 months
In both arms treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 27-60 patients 18-40 for study drug 9-20 for placebo before cross-over 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 |
|---|---|---|---|
| CDR0000393574 | REGISTRY | PDQ Physician Data Query | None |