Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia

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: NCT00052611
Recruitment Status : Unknown
Verified January 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing head and neck cancer in patients who have oral leukoplakia or head and neck dysplasia.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.

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

Detailed Description:


  • Determine the response rate, in terms of prostaglandin E2 expression, in patients with oral leukoplakia and/or dysplasia treated with celecoxib.
  • Determine the change in other biomarkers including COX-2, Ak+, Ki-67, BCL2, BAX, VEGF, and CD31, in patients treated with this drug.
  • Determine the efficacy of this drug, in terms of reducing the size of oral leukoplakia lesions and presence of dysplasia, in these patients.
  • Correlate change in biomarker expression with response of oral leukoplakia lesions and/or dysplasia in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a repeat biopsy. Patients with a positive response receive celecoxib for an additional 9 months.

Patients are followed every 3-6 months for 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study
Study Start Date : June 2002

Information from the National Library of Medicine

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


  • Oral leukoplakia on clinical examination AND/OR
  • More than one prior squamous cell carcinoma (SCC) of the head and neck and dysplasia on biopsy within the past 6 months
  • Carcinoma in situ or new leukoplakia eligible provided treatment for a prior carcinoma was completed more than 9 months ago



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 months


  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • No bleeding diathesis


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Transaminases less than 1.5 times ULN
  • PT/PTT less than 1.5 times ULN
  • No acute or chronic liver disease


  • Creatinine less than 1.5 times ULN
  • Urine protein less than 2+
  • No acute or chronic renal insufficiency


  • No New York Heart Association class II congestive heart failure
  • No prior myocardial infarction
  • No angina
  • No known coronary artery disease


  • No advanced chronic obstructive pulmonary disease requiring home oxygen use


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No infection within the past 2 weeks
  • No concurrent infection
  • No concurrent tobacco use (e.g., cigarette, cigar, pipe, or chewing tobacco)

    • At least 1 month since prior use
  • No active alcohol abuse
  • No history of gastrointestinal ulcer
  • No history of anaphylactoid reaction to aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
  • No concurrent active malignancy except non-melanoma skin cancer
  • No contraindication to nasopharyngoscopy and biopsy


Biologic therapy

  • No concurrent biologic therapy


  • No concurrent chemotherapy

Endocrine therapy

  • More than 3 months since prior absorbed steroids, including inhaled and nasal steroids (3 times a week for at least 2 consecutive weeks)

    • Prior mometasone allowed


  • No concurrent radiotherapy


  • Prior surgery for SCC of the head and neck allowed provided patient has been cancer free for at least 9 months


  • More than 3 months since prior full-dose aspirin, COX-2 inhibitors, or NSAIDs (at least 3 times a week for at least 2 weeks)
  • More than 3 months since prior retinoids or selenium
  • No concurrent lithium or fluconazole
  • No concurrent diuretics for congestive heart failure
  • No concurrent angiotensin-converting enzyme inhibitors
  • Concurrent aspirin allowed if dosage no greater than 81 mg per day

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): NCT00052611

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Lori J. Wirth, MD Dana-Farber Cancer Institute Identifier: NCT00052611     History of Changes
Other Study ID Numbers: CDR0000258562
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: January 2005

Keywords provided by National Cancer Institute (NCI):
lip and oral cavity cancer
paranasal sinus and nasal cavity cancer
hypopharyngeal cancer
laryngeal cancer
oropharyngeal cancer
nasopharyngeal cancer
salivary gland cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents