Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
This study has been completed.
Sponsor:
Fox Chase Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00101335
First received: January 7, 2005
Last updated: March 2, 2011
Last verified: January 2005
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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 Condition |
Drug: celecoxib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | September 2004 |
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
Investigators
| Principal Investigator: | Paul F. Engstrom, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00101335 History of Changes |
| Other Study ID Numbers: | CDR0000393574, FCCC-02028 |
| Study First Received: | January 7, 2005 |
| Last Updated: | March 2, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
hypopharyngeal cancer lip and oral cavity cancer nasopharyngeal cancer |
oropharyngeal cancer tongue cancer oral leukoplakia |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Leukoplakia Leukoplakia, Oral Precancerous Conditions Neoplasms by Site Neoplasms Pathological Conditions, Anatomical Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013