Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Inclusion criteria

・ Eligibility criteria

• Histological diagnosis of gastric adenocarcinoma.
• Measurable or assessable lesions.
• Age: 18 ~ 75 years.
• Performance Status (ECOG): 0 ~ 2.
• No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
• No history of treatment with CPT-11 or S-1.
• No history of radiotherapy to the abdomen.
• Oral intake of S-1 is possible.
• Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
• Predicted survival for >3 months.
• Able to give written informed consent

Exclusion criteria

• Severe pleural effusion or ascites.
• Metastasis to the central nervous system (CNS).
• Active gastrointestinal bleeding.
• Active infection.
• Diarrhea (watery stools).
• Uncontrolled ischemic heart disease.
• Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
• Active multiple cancer.
• Severe mental disorder.
• Pregnancy, possible pregnancy, or breast-feeding.
• Flucytosine treatment
• Gilbert's syndrome.
• Judged to be ineligible for this protocol by the attending physician.