- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101335
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul F. Engstrom, MD, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Stomatognathic Diseases
- Mouth Diseases
- Pathological Conditions, Anatomical
- Mouth Neoplasms
- Head and Neck Neoplasms
- Precancerous Conditions
- Leukoplakia
- Leukoplakia, Oral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- FCCC-02028
- CDR0000393574 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Radboud University Medical CenterUnknown
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