Phase I Open Label Trial Of Intraperitoneal Paclitaxel (Ipp) In Combination With Intravenous Cisplatin (C) And Oral Capecitabine (X) In Patients With Advanced Gastric Cancer And Peritoneal Metastases.

TPS201Background: There have been few studies investigating advanced gastric cancer with peritoneal involvement and ascites, showing poor survival in these patients. Researchers from Japan have shown that chemotherapy with IPP and Oral S-1 (tegafur/gimeracil/oteracil) is active in these patients. These results have been achieved in a different genetic pool (Japanese population) compared with Australia, using regimens that are not available here. We have designed this phase I trial to investigate the Maximum Tolerated Dose (MDT) of IPP in combination with a standard chemotherapy combination (C+X) in these patients. Methods: This is an open-label, single centre, phase I trial with 3+3 expanded cohort design. Patients will have an IP catheter placed surgically after trial enrolment. Study was approved by the relevant ethics committee. Chemotherapy: maximum of six 21-day cycles of: X (PO, 1000 mg/m2 BD days 1-14) + C (IV 80mg/m2 day 1) + IPP (day 1 and 8) with the following doses: Cohort-1: 10 mg/m2, Cohort-2...