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.

1. Inclusion Criteria:

   • 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),

2. Exclusion Criteria:

   • other active concomitant malignancies
   • HER2(human epidermal growth factor receptor 2) positive (Immunohistochemistry 3+ or 2+ with in situ hybridization positive)
   • no investigational anticancer therapy within 30 days prior to the first dose of study treatment
   • recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease
   • uncontrolled acute or chronic disease
   • uncontrolled infection or inflammation
   • uncontrolled psychiatric disorder or central neurologic disease
   • not fully recovered from previous surgery
   • prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months
   • intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome
   • fertile males and females who are unwilling to use effective contraceptive methods.
   • pregnancy, breast feeding or intention to become pregnant
   • interstitial pneumonia or pulmonary fibrosis
   • peripheral neuropathy with functional impairment
   • hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or Cremophor EL.
   • concomitant therapy with any substrate or inhibitor of Cytochrome P450 2C8 or 3A4
   • concomitant therapy with sorivudine or brivudine
   • Dihydropyrimidine dehydrogenase (DPD) deficiency.
   • current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium