Expired Study
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Philadelphia, Pennsylvania 19111


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.


Study summary:

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.


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


Study is Available At:


Original ID:

FCCC-02028


NCT ID:

NCT00101335


Secondary ID:

CDR0000393574


Study Acronym:


Brief Title:

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


Official Title:

A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fox Chase Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Double-Blind, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Paul F. Engstrom, MD
Principal Investigator
Fox Chase Cancer Center

Study Dates

Start Date:November 2003
Completion Date:January 2005
Completion Type:Actual
Primary Completion Date:January 2005
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 9, 2013
First Received Date:January 7, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:celecoxib

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fox Chase Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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