Phase I/Ii Study Of A Combination Of Capecitabine, Cisplatin, And Intraperitonealdocetaxel (Xp Id) In Patients With Advanced Gastric Cancer With Peritoneal Metastasis

4026 Background: More than one third of patients with advanced gastric cancer (AGC) have peritoneal metastasis, and their prognosis is poor. This study was conducted to determine the recommended dose (RD) of intraperitoneal docetaxel (ID) in combination with systemic capecitabine and cisplatin (XP), and to evaluate its efficacy and safety at the RD in AGC patients with peritoneal metastasis. Methods: AGC patients with peritoneal metastasis received XP ID, which consists of 937.5 mg/m2 of capecitabine twice daily on days 1-14, 60 mg/m2 of intravenous cisplatin on day 1, and ID at 3 different dose levels (60, 80, or 100 mg/m2) on day 1, every 3 weeks. In the phase I study, the standard 3+3 method was used to determine the RD of XP ID. For the phase II study, patients received RD of XP ID until disease progression, unacceptable toxicity, or consent withdrawal. A maximum of 8 cycles of ID was provided. Results: In the phase I study, 3 patients experienced no dose limiting toxicity (DLT) at each of 60 or 80 mg...