Phase II trial of docetaxel (D) and high-dose celecoxib (C) in patients (Pts) with hormone resistant prostate cancer (HRPC)

4616 Background: COX-2 is an inducible enzyme, which converts arachidonic acid to prostaglandins. COX-2 is over expressed in 89.3% of our pts with prostate cancer and is an independent predictor of survival (Cogswell et al; Proc ASCO 2003, #1675). Both D and C are angiogenesis inhibitors and induce apoptosis; their combination could be synergistic. In an ongoing pilot trial we determined the effects on PSA, Overall Response(OR), toxicity, and survival. Methods: Eighteen (18) pts with HRPC progressing by rising PSA and radiographic manifestations were treated with D 30mg/m2 IV over 30min,weekly for 3 wks and C 400mg po bid daily of each 4wk cycle. All pts were assessed by PSA and radiological tests every 2 cycles. Dose modifications for hematologic, hepatic and renal toxicity were made. Detailed renal function tests were assessed by a nephrologist. The RECIST criteria and PSA decline by ≥50% were used. Sample size was determined by Simon's Optimal Two-Stage design. Results: The median age was 73.5 years(55...