Phase I,II Study of First Line Intraperitoneal Paclitaxel With Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis
IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis. Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.
⁃ ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
• pathologically proven primary gastric adenocarcinoma
• peritoneal metastasis confirmed by laparoscopy or diagnostic imaging
• written informed consent
• adequate function of important organs (within 14 days before registration)
‣ Absolute neutrophil count ≥1.5 x 10\^9/L, Platelet \>=100,000/mm3, Hemoglobin \>=8.0g/dL, Total bilirubin \<= ≤ 2.0mg/dl or ULN(Upper Limit of Normal) x 1.5, AST(aspartate aminotransferase) \<=100IU/L(International Unit/Liter), ALT(alanine transaminase) \<=100IU/L, Creatinine clearance ≥ 50mL/min (milliliter/minute),