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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. Identifier: NCT00101335
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : July 11, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Precancerous Condition Drug: celecoxib Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00101335

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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Paul F. Engstrom, MD Fox Chase Cancer Center

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Responsible Party: Fox Chase Cancer Center Identifier: NCT00101335     History of Changes
Other Study ID Numbers: FCCC-02028
CDR0000393574 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 10, 2005    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Fox Chase Cancer Center:
hypopharyngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer
oropharyngeal cancer
tongue cancer
oral leukoplakia
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Precancerous Conditions
Leukoplakia, Oral
Neoplasms by Site
Pathological Conditions, Anatomical
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action