Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00101335|
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : July 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Precancerous Condition||Drug: celecoxib||Phase 2|
- 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.
- Determine the effect of this drug in modulating multiple intermediate biomarkers (e.g., COX-2, PPARγ, or PPARδ) 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 Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101335
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Paul F. Engstrom, MD||Fox Chase Cancer Center|