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• W90281839 abstract "14055 Background: COX-2 is overexpressed during cancer progression in several solid tumors, including P and BT, and constitutes an attractive therapeutic target. Selective COX-2 inhibitors, such as celecoxib, have been successfully combined with fluoropyrimidine-based regimens, resulting in a lower-than-expected hematologic, GI, and skin toxicity rate. Methods: Advanced P or BT patients (pts), progressing after first-line treatment, were eligible for the study. Capecitabine was administered at 1000 mg/m 2 b.i.d. on days 1–14 q3 weeks; celecoxib was administered at 200 mg b.i.d. continuously starting on day 1. PFS was the primary endpoint. ORR, toxicity, OS, clinical benefit (CB), and QoL were secondary endpoints. Assuming that a rate of PFS >15% at 3 mos would be considered of interest in this pt population, an accrual of 28 pts was planned according to the exact single-stage phase II design described by A’Herne. Results: To date, 25 pts have been accrued (M/F: 11/14; median age: 64 yrs, range 39–75; P/BT: 18/7; PS 0–1/2–3: 19/6). All pts completed at least 1 treatment cycle (median: 3, range 1–9). Twenty-three pts are currently evaluable for response: 1 PR and 1 MR (duration: 33 and 27+ wks) were observed, both in pts with P; 5 additional pts showed SD (duration: 10+, 21, 22+, 27, and 42 wks); the remaining 16 pts had PD. All pts and 83 cycles are evaluable for toxicity. Hematological toxicity was negligible; only 4 pts experienced G3 non-hematological toxicities: diarrhea (2 pts, 2 cycles), skin toxicity (1 pt, resolved with treatment delay), asthenia (1 pt, 2 cycles), and GI bleeding (1 pt, requiring treatment interruption after cycle 1). To date, 19 pts have progressed and 15 pts have died: median PFS is 11 wks (range 3–42) and median OS is 16 wks (range 4–54). Nineteen pts had elevated CA19.9 serum levels at baseline, which decreased of > 25% during treatment in 7 pts, remained stable in 3 pts, and increased in 9 pts. The evaluation of CB and QoL is ongoing. Conclusions: CapCel is a feasible and well-tolerated, fully oral, treatment regimen for advanced P and BT patients, which shows activity, albeit modest, even in a second-line setting. Further evaluation of this therapeutic strategy is warranted. No significant financial relationships to disclose." @default.
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• W90281839 date "2006-06-20" @default.
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• W90281839 title "Pilot study of capecitabine combined with celecoxib (CapCel) as second-line treatment for advanced pancreatic (P) and biliary tree (BT) cancer" @default.
• W90281839 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.14055" @default.
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