RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing head and neck cancer in patients who have oral leukoplakia or head and neck dysplasia.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.

Condition	Treatment or Intervention	Phase
Head and Neck Cancer	Drug: celecoxib  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer	Phase II

Further Study Details: 

OBJECTIVES:

• 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 months.

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 months

Hematopoietic

• Platelet count at least 100,000/mm^3
• Absolute neutrophil count greater than 1,500/mm^3
• No bleeding diathesis

Hepatic

• 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

Renal

• Creatinine less than 1.5 times ULN
• Urine protein less than 2+
• No acute or chronic renal insufficiency

Cardiovascular

• No New York Heart Association class II congestive heart failure
• No prior myocardial infarction
• No angina
• No known coronary artery disease

Pulmonary

• No advanced chronic obstructive pulmonary disease requiring home oxygen use

Other

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent biologic therapy

Chemotherapy

• 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

Radiotherapy

• No concurrent radiotherapy

Surgery

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

Other

• 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

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

Study chairs or principal investigators

Lori J. Wirth, MD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000258562; DFCI-02024; DFCI-2002-P-00150/2; NCT00052611
Record last reviewed:  March 2005
Last Updated:  March 3, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052611
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08