Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.

Inclusion Criteria: Histologically confirmed metastatic or recurrent gastric cancer with prior treatment for advanced disease. Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to the beginning of study therapy At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques(Except for Phase I setting). Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent Patients with performance status(ECOG) 0 to 2 Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥ 100 x 109/L) Serum cleatinine ≤ 1.5mg/dl Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.0 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases) Normal ECG Life expectancy ≥ 3 months Patients who have given written informed consent to participate in this study Exclusion Criteria: Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting) Serious, uncontrolled, concurrent infection(s) or illness(es) Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia) Patients with Liver cirrhosis Patients with fresh hemorrhage from the gastrointestinal tract Patients with poorly controlled diabetes or are treated by continuous use of insulin Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment Patients with diarrhea (watery stool) Patients with infection, intestinal palsy or intestinal occlusion Patients with brain metastasis Patients with Gilbert syndrome Patients who have experienced serious drug allergy in the past Patients who are pregnant and lactating or hope to become pregnant during the study period Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment Patients with neuropathy ≥ grade 2 Others, patients judged by the investigator or subinvestigator to be inappropriate as subject