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