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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Precancerous Condition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Paul F. Engstrom, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000393574

NCT ID:

NCT00101335

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Precancerous Condition
  • hypopharyngeal cancer
  • lip and oral cavity cancer
  • nasopharyngeal cancer
  • oropharyngeal cancer
  • tongue cancer
  • oral leukoplakia
  • Head and Neck Neoplasms
  • Leukoplakia
  • Leukoplakia, Oral
  • Precancerous Conditions

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111