Clinical trial · Interventional
Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SQUAMOUS CELL CARCINOMA | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: celecoxib
Primary outcomes (1)
- measure
- • To determine feasibility of measuring molecular changes (COX-2 mRNA, eicosanoid profiles, Ki67, p-EGFR) in head and neck squamous cell carcinoma induced by short-term celecoxib treatment.
- timeFrame
- 6 years
Secondary outcomes (1)
- measure
- To evaluate feasibility of measuring effect of short-term celecoxib treatment on blood & urinary concentrations of angiogenesis markers/on blood concentrations of IGF-1 & IGFBP-3/on urinary concentration of PGE-M.
- timeFrame
- 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available