Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-29 @ 12:18 AM
Study NCT ID:
NCT00101335
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2005-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Sponsor:
Fox Chase Cancer Center
Organization:
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 (e.g., 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 (e.g., 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:
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000393574 | REGISTRY | PDQ (Physician Data Query) | View |