Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to better understand how to use celecoxib, a popular drug widely used for arthritis, for head and neck cancer patients. Some doctors believe that celecoxib may have helpful effects when used for head and neck cancer. Celecoxib has been shown to prevent some cancers in animals. It has also been used to make standard chemotherapy and radiation work better in both animals and humans. However, all of the previous studies focused on tumors outside the head and neck region. To better understand how to use celecoxib for head and neck cancer patients, doctors at MSKCC are studying the effects of the drug on certain chemicals in the body that are thought to be important for cancer treatment.

This study aims to measure how celecoxib affects those chemicals, which can be found in the tumor, blood, and urine of patients with head and neck cancer. Although celecoxib is already used to treat arthritis, this study will be the first to test the drug in head and neck cancer patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Untreated squamous cell carcinoma of the oral cavity or oropharynx.

• Older than 18 years of age.

• Understand and sign informed consent.

Exclusion Criteria:

• Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.

• Breast-feeding, pregnancy or of childbearing potential (including at least two years post menopause) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.

• History of esophageal, gastric or duodenal ulceration within 6 weeks of enrollment.

• History of acute or chronic renal disorder (blood creatinine level > 1.5 mg/dL).

• History of acute or chronic hepatic disorder or a significant bleeding disorder.

• History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease,rheumatoid arthritis or pancreatitis).

• History of myocardial infarction, angina, or coronary artery disease within the past 6 months, or active cardiac disease.

• The subject is of New York Heart Association (NYHA) Class 3 or 4 cardiac status.

• Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.

• NSAID (including celecoxib) or aspirin (> 81 mg/day) use within 1 week of enrollment.

• History of hypersensitivity to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides.

• Currently taking fluconazole or lithium.

• Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.

• Principal Investigator deems subject to be at high risk for non-compliance.