This trial is active, not recruiting.

Condition head and neck cancer
Treatment celecoxib
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date June 2002
Trial identifier NCT00052611, CDR0000258562, DFCI-02024, DFCI-2002-P-00150/2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Masking open label
Primary purpose prevention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).