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Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study


- Determine the response rate, in terms of prostaglandin E2 expression, in patients with
oral leukoplakia and/or dysplasia treated with celecoxib.

- Determine the change in other biomarkers including COX-2, Ak+, Ki-67, BCL2, BAX, VEGF,
and CD31, in patients treated with this drug.

- Determine the efficacy of this drug, in terms of reducing the size of oral leukoplakia
lesions and presence of dysplasia, in these patients.

- Correlate change in biomarker expression with response of oral leukoplakia lesions
and/or dysplasia in patients treated with this drug.

- Determine the toxic effects of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a
repeat biopsy. Patients with a positive response receive celecoxib for an additional 9

Patients are followed every 3-6 months for 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.

Inclusion Criteria


- Oral leukoplakia on clinical examination AND/OR

- More than one prior squamous cell carcinoma (SCC) of the head and neck and dysplasia
on biopsy within the past 6 months

- Carcinoma in situ or new leukoplakia eligible provided treatment for a prior
carcinoma was completed more than 9 months ago



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 months


- Platelet count at least 100,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

- No bleeding diathesis


- Bilirubin less than 1.5 times upper limit of normal (ULN)

- Transaminases less than 1.5 times ULN

- PT/PTT less than 1.5 times ULN

- No acute or chronic liver disease


- Creatinine less than 1.5 times ULN

- Urine protein less than 2+

- No acute or chronic renal insufficiency


- No New York Heart Association class II congestive heart failure

- No prior myocardial infarction

- No angina

- No known coronary artery disease


- No advanced chronic obstructive pulmonary disease requiring home oxygen use


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No infection within the past 2 weeks

- No concurrent infection

- No concurrent tobacco use (e.g., cigarette, cigar, pipe, or chewing tobacco)

- At least 1 month since prior use

- No active alcohol abuse

- No history of gastrointestinal ulcer

- No history of anaphylactoid reaction to aspirin, nonsteroidal anti-inflammatory drugs
(NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors

- No concurrent active malignancy except non-melanoma skin cancer

- No contraindication to nasopharyngoscopy and biopsy


Biologic therapy

- No concurrent biologic therapy


- No concurrent chemotherapy

Endocrine therapy

- More than 3 months since prior absorbed steroids, including inhaled and nasal
steroids (3 times a week for at least 2 consecutive weeks)

- Prior mometasone allowed


- No concurrent radiotherapy


- Prior surgery for SCC of the head and neck allowed provided patient has been cancer
free for at least 9 months


- More than 3 months since prior full-dose aspirin, COX-2 inhibitors, or NSAIDs (at
least 3 times a week for at least 2 weeks)

- More than 3 months since prior retinoids or selenium

- No concurrent lithium or fluconazole

- No concurrent diuretics for congestive heart failure

- No concurrent angiotensin-converting enzyme inhibitors

- Concurrent aspirin allowed if dosage no greater than 81 mg per day

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Prevention

Principal Investigator

Lori J. Wirth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • lip and oral cavity cancer
  • paranasal sinus and nasal cavity cancer
  • hypopharyngeal cancer
  • laryngeal cancer
  • oropharyngeal cancer
  • nasopharyngeal cancer
  • salivary gland cancer
  • Head and Neck Neoplasms
  • Leukoplakia, Oral



Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115