Adding the specific COX-2 inhibitor celecoxib to docetaxel plus carboplatin in first line for stage IC-IV epithelial ovarian cancer: A randomized phase II study

5545 Background: Inhibition of COX-2 reduces the growth rate of tumors in vitro and COX-2 is over-expressed in ovarian cancer, so a COX-2 inhibitor might be beneficial. Methods: After debulking surgery patients (pts) with advanced epithelial ovarian cancer (FIGO IC-IV) received docetaxel 75 mg/m2 and carboplatin AUC=5 (CT) for 6–9 cycles q 3-wks and were randomized to celecoxib 400 mg BID (COX) for max three years or to control (CTR), stratified for residual tumor present in 58% vs 54%. Response rates and progression-free survival were based on CA-125 levels according to Rustin. Primary endpoints were biochemical CR (bCR)and safety, secondary progression free- (PFS) and overall survival (OS). Results: 183 of 201 pts enrolled were analyzed and baseline characteristics were well balanced between COX (n = 91) and control (CTR) arms (n = 93). Safety: Docetaxel and carboplatin was given full dose in 89% vs 84% pts and creatinine clearance remained stable vs baseline in both arms (96% vs 97% at Cycle 6). Toxici...