Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
First received: January 7, 2005
Last updated: July 9, 2013
Last verified: July 2013

January 7, 2005
July 9, 2013
November 2003
January 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00101335 on ClinicalTrials.gov Archive Site
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Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia

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.



  • 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.

Phase 2
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
  • Head and Neck Cancer
  • Precancerous Condition
Drug: celecoxib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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January 2005
January 2005   (final data collection date for primary outcome measure)


  • Diagnosis of oral leukoplakia with hyperplasia or dysplasia

    • Documented by baseline biopsy of oral lesions suspicious for leukoplakia
    • For patients using dentures over the past 6 months, only lesions located on the ventral-lateral tongue or floor of the mouth are allowed
    • No leukoplakia/hyperplasia secondary to mechanical irritation
  • No carcinoma in situ of the oral cavity



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 1 year


  • Hemoglobin ≥ 10 g/dL (women) OR ≥ 11 g/dL (men)


  • AST or ALT normal
  • Bilirubin normal


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No myocardial infarction within the past 12 months
  • No known active ischemic cardiac disease by stress test or echocardiogram


  • No history of gastrointestinal hemorrhage
  • No known gastrointestinal ulcers within the past 2 years unless there is documentation of healed lesions by upper endoscopy
  • No active or suspected peptic ulcer disease
  • Negative stool guaiac test


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study treatment
  • No use of snuff or chewing tobacco within the past 2 months
  • No active invasive malignancy within the past 3 years except nonmelanoma skin cancer or in situ carcinomas
  • No clinical evidence of chronic infectious disease
  • No clinical evidence of connective tissue disease
  • No known hypersensitivity (asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs
  • No known hypersensitivity to sulfonamides


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • At least 6 months since prior chronic or frequent use of systemic glucocorticoids
  • No concurrent chronic or frequent use of systemic glucocorticoids


  • Not specified


  • Not specified


  • No prior chronic or frequent (> 100 mg per day aspirin equivalent) use of nonsteroidal anti-inflammatory drugs (NSAIDs) for 7 of the past 14 days
  • At least 3 months since prior experimental therapy
  • No concurrent chronic or frequent use of NSAIDs

    • Cardioprotective doses of aspirin ≤ 100 mg daily are allowed
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
FCCC-02028, CDR0000393574
Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Paul F. Engstrom, MD Fox Chase Cancer Center
Fox Chase Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP