Radiosensitization With A Cox2 Inhibitor With Chemoradiation For Head And Neck Cancer.

5582 Background: Cyclo-oxygenase 2 (COX2) inhibitors have shown promise as radio- and chemosensitizers. We conducted a phase IB/II study to evaluate the toxicity and efficacy of celecoxib, a selective COX2 inhibitor, administered concurrently with carboplatin, paclitaxel, and radiation for locally advanced or recurrent head and neck cancer. Methods: Patients with stage III/IV or recurrent squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx were eligible. Primary endpoints were toxicity, local control and survival. Patients were treated with weekly carboplatin (AUC = 2.0), paclitaxel (30 mg/m2) and concurrent radiation (70 Gy). Celecoxib (400 mg bid) was started 1 week prior to the initiation of radiotherapy and was given for a total of 2 years. In 12/04, the study closed due to concerns of cardiotoxicity with COX-2 inhibitors. Celecoxib was discontinued in all patients. The study restarted in 5/06 with the modification that celecoxib would be given only during radiation. Results...