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

NCT00101335 | Completed Phase 2

• 2 other identifiers: FCCC-02028CDR0000393574
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Precancerous Condition

Keywords

hypopharyngeal cancer; lip and oral cavity cancer; nasopharyngeal cancer; oropharyngeal cancer; tongue cancer; oral leukoplakia

Interventions

celecoxib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Precancerous Conditions; Hypopharyngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms; Tongue Neoplasms; Leukoplakia, Oral

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Diseases; Tongue Diseases; Leukoplakia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul F. Engstrom, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: November 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (1)