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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00101335
First received: January 7, 2005
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Head and Neck Cancer
Precancerous Condition
Drug: celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Study Start Date: November 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 1 year

Hematopoietic

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

Hepatic

  • AST or ALT normal
  • Bilirubin normal

Renal

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

Cardiovascular

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

Gastrointestinal

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101335

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Paul F. Engstrom, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00101335     History of Changes
Other Study ID Numbers: FCCC-02028, CDR0000393574
Study First Received: January 7, 2005
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

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:
Head and Neck Neoplasms
Leukoplakia
Leukoplakia, Oral
Precancerous Conditions
Neoplasms by Site
Neoplasms
Pathological Conditions, Anatomical
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 23, 2014