Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia - Full Text View

Sponsors and Collaborators:	Fox Chase Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00101335

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/Nonmalignant Condition	Drug: celecoxib	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

September 2004

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Paul F. Engstrom, MD

Fox Chase Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000393574, FCCC-02028
Study First Received:	January 7, 2005
Last Updated:	October 12, 2008
ClinicalTrials.gov Identifier:	NCT00101335
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Mouth Diseases
Leukoplakia, Oral
Celecoxib
Precancerous Conditions
Mouth Neoplasms
Lip and oral cavity cancer

Oral leukoplakia
Nasopharyngeal carcinoma
Head and Neck Neoplasms
Oral cancer
Leukoplakia
Hypopharyngeal cancer
Stomatognathic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009