Cox-2 Inhibition in Radiation-induced Oral Mucositis

Key Inclusion Criteria:

• Patients who will be receiving at least 5000 centigray (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 Non-steroidal anti-inflammatory drugs (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.