PH II STUDY/ PREOPERATIVE CELECOXIB/ PACLITAXEL/ CARBOPLATIN LUNG CANCER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The aim of this randomized double blind phase II study is to determine whether the addition of celecoxib (400mg bid) to a preoperative regimen of paclitaxel and carboplatin enhances the pathological response rate in patients for Stage IIIA non small-cell lung cancer. The primary endpoint will be the determination of the CPR rate (defined as complete eradication of tumor or minimal residual microscopic disease) following 3 cycles of neoadjuvant chemotherapy. The secondary endpoints are to determine the clinical response rates, treatment related toxicities, time to progression (TTP), disease free survival (DFS) and overall survival (OS) in patients treated with placebo versus celecoxib.