Clinical trial · Interventional
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
NCT00101335CI-TRIAL-00011327completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.