Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma
The selective cyclo-oxygenase 2 (COX-2) inhibitor, celecoxib (Celebrex, Pfizer Inc.), is
being investigated as an anticancer agent in chemoprevention and adjuvant therapeutic
regimens in many organ systems including the head and neck, lung, colon, breast and bladder.
The mechanisms of action are not fully defined and, to date, there are no data regarding the
shortterm molecular effects of celecoxib treatment in human tumor tissues. These data are
important for understanding the targets and effects of COX-2 inhibitors in cancer.
Specifically, this pilot study seeks to evaluate the feasibility of determining whether
celecoxib treatment inhibits COX-2 expression, alters the intratumor eicosanoid profile,
and/or suppresses markers of proliferation and growth in human tumor tissues. In addition,
this trial aims to evaluate the feasibility of reliably measuring the effects of celecoxib
treatment on biomarkers of angiogenesis, prostaglandin metabolism and select growth factors.
The study is titled: "Molecular effects of short-term celecoxib treatment on head and neck
squamous carcinoma." In this study, 10 patients identified in the Head and Neck Surgical
Oncology clinic at MSKCC with untreated squamous cell carcinoma of the oral cavity or
oropharynx will be recruited to participate. Participation will not change the standard of
cancer care that the patients receive. At the initial office evaluation the tumor will be
biopsied. Blood and urine will also be collected. Patients will then take oral celecoxib
(400 mg) twice daily starting exactly 5 days prior to staging examination under anesthesia
or definitive resection and including the morning of surgery. The tumor will then be
re-biopsied at the time of staging examination under anesthesia or surgical resection. Blood
and urine will similarly be re-collected at that time.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• 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.
Jay Boyle, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board