Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer

Single-center, open-label, prospective, single-arm, phase I-II study

About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)

Inclusion criteria

• Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
• Peritoneal seeding proven by histology or cytology
• Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded)
• Age 18 to 70 years old
• Eastern Cooperative Oncology Group performance status <_ 2
• Estimated life expectancy of more than 3 months
• Adequate bone marrow function (WBCs>3,000/µL and absolute neutrophil count (ANC) >1,500/µL and platelets>100,000/µL),
• Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance _> 60ml/min
• Adequate hepatic function: bilirubin < 1.5 x UNL, AST/ALT levels < 2.5 x UNL, alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)
• Written informed consent

Exclusion criteria

• Contraindication to any drug contained in the chemotherapy regimen
• Other tumor type than adenocarcinoma
• Presence or history of CNS metastasis
• Gastric outlet or bowel obstruction
• Evidence of serious gastrointestinal bleeding
• Peripheral neuropathy > grade 2
• History of significant neurologic or psychiatric disorders
• History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Other serious illness or medical conditions