A Phase II Study of Irinotecan, Oxaliplatin, Plus TS-1 in Untreated Metastatic Gastric Cancer

Inclusion criteria

• Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Disease status must be that of measurable disease as defined by RECIST criteria:Measurable lesions: Lesions that can be accurately measured in at least one dimension by any of the following: - CT of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT- Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
• No prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant therapy is allowed if at least 12 months have elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study. However, prior oxaliplatin and/or irinotecan as adjuvant therapy are not allowed.
• Adequate major organ function including the following: Hematopoietic function: ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin 1.5 mg/dl, AST/ALT levels 2.5 x UNL ( 5 x UNL if liver metastases are present)Renal function: serum creatinine UNL
• Patients should sign a written informed consent before study entry

Exclusion criteria

• Prior history of peripheral neuropathy
• Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
• Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
• Psychiatric disorder that would preclude compliance
• Pregnant, nursing women or patients with reproductive potential without contraception
• Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine