Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

Key

Inclusion Criteria:

- Patients who will be receiving at least 5000 cGy radiation therapy to at least 2 of
14 pre-defined areas in the oral cavity.

- Women of childbearing potential must agree to use a medically accepted form of
contraception during the course of the study. Women of childbearing potential must
have a documented negative pregnancy test within fourteen days of enrollment in the
study.

- Patient's willing and able to provide written informed consent for the study.

Key Exclusion Criteria:

- Patients with known hypersensitivity to celecoxib or other COX-2 inhibitors.

- Patients who have experienced asthma, urticaria, or allergic-type reactions after
taking salicylates (e.g. aspirin) or NSAIDs.

- Patients who have demonstrated allergic-type reactions to sulfonamides.

- Patients with a history of gastric, esophageal, pyloric channel or duodenal ulcer
disease or gastrointestinal bleeding.

- Patients with a history of inflammatory bowel disease (e.g. Crohn's disease,
ulcerative colitis) or pancreatic disease.

- Patients with severe hepatic impairment.

- Patients with advanced renal disease.

- Patients with a significant bleeding disorder.

- Patients under the age of 18 or over the age of 75.

- Women who are pregnant or nursing.

- Patients with a history of thromboembolic events including myocardial infarction,
pulmonary embolism, deep venous thrombosis, transient ischemic attack and ischemic
cerebrovascular accident (stroke).

- Patients who have had coronary angioplasty, coronary artery bypass surgery or another
cardiac revascularization procedure.

- Patients with a history of a cardiac arrhythmia requiring anti-arrhythmic therapy,
angina pectoris or congestive heart failure.