Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patient at increased risk for developing a new head and neck squamous cell carcinoma are invited to take part in this study.

The investigators of this trial will attempt to study the effectiveness of Celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Subjects will be ≥ 18 years.

• Subjects will have oral leukoplakia on clinical examination and/or more than one previous HNSCC with dysplasia histologically proven on random biopsy within 6 months at the time of entry.

• Patients who have had surgical treatment for a previous HNSCC, stage I-III, will be eligible for enrollment if they are cancer-free ≥ 9 months at the time of entry. Patients with CIS or new leukoplakia will be immediately eligible if they are more then 9 months from treatment of a prior carcinoma.

• Leukoplakia lesions must be ≥ 0.5 cm in at least one dimension to be considered measurable. Measurable lesions are not required for entry.

• The ECOG performance status will be ≤ 2. (See Appendix B for ECOG performance status.)

• The life expectancy will be ≥12 months.

• Subjects will have adequate organ function with a platelet count of >100,000, ANC > 1500, PT and PTT < 1.5 X ULN, creatinine <1.5, urine protein <2+, and total bilirubin and liver transaminases <1.5 X ULN.

• Premenopausal women will be required to use a reliable method of birth control throughout the course of therapy.

• Subjects will provide written, voluntary informed consent

Exclusion Criteria:

• Patients who have had surgical treatment for a previous HNSCC, stage I-III, will not be eligible for enrollment if they are cancer-free < 9 months at the time of entry.

• Subjects with contraindication to nasopharyngoscopy and biopsy will not be enrolled.

• Significant comorbidities, including known coronary artery disease, angina, history of myocardial infarction, congestive heart failure of at least grade 2 according to the New York Heart Association Criteria, advanced COPD requiring use of home oxygen, active alcohol abuse, bleeding diathesis, any history of gastrointestinal ulcer, acute or chronic renal insufficiency, or acute or chronic liver disease, will preclude enrollment in the trial.

• Enrollment in the trial will be limited to patients who are free from current tobacco use. If the patient has a history of previous tobacco use, they Must be abstinent for at least 1 month prior to enrollment and meet the criteria established by the Food and Drug Administration for assessing smoking cessation, i.e. have not taken even a puff or taste of tobacco, including cigarette, cigar, pipe, chewing tobacco or other tobacco products, in the past 4 weeks.

• Any active malignancy, except non-melanoma skin cancer, will preclude enrollment.

• Persons who have taken full-dose aspirin, NSAIDs, COX-2 inhibitors and systemicallyabsorbed steroids, including inhaled steroids and nasal steroids other than mometazone, at least 3 times per week for 2 or more consecutive weeks within 3 months of enrollment will be excluded. Persons who have taken retinoids or selenium within 3 months of enrollment, or who have a history of anaphylactoid reaction to aspirin, NSAIDs or COX- 2 inhibitors will not be enrolled.

• Persons taking ACE inhibitors will not be enrolled. Diuretics for CHF, or treatment with lithium or fluconazole will also preclude enrollment. Patients on coumadin will be required to have PT/INR monitoring BIW after starting celecoxib, until the patient is on a stable dose of coumadin for 7 days, and must have no contraindication to holding the coumadin for study biopsies.

• Pregnant, lactating women or premenopausal women with a positive f3HCG will not be enrolled in the study.