14059 Background: There is currently no standard treatment for gastric carcinoma patients (pts) who failed initial chemotherapy. Since performance status of these pts deteriorates rapidly, moderate and dose-fractionated single agent regimens have been preferred in Japan in the second line setting. Weekly paclitaxel, one of commonly used regimens in this setting, was explored for the first time in a formal phase II study. Methods: Pts with histologically confirmed gastric carcinoma who had unresectable or recurrent disease with ≥1 measurable lesions per RECIST were eligible. Other eligibility criteria included confirmed progressive disease (PD) per RECIST during a front line chemotherapy, PS ≤2, adequate liver, kidney, and marrow functions, no active gastrointestinal bleeding, and written informed consent. Patients received 80 mg/m2 of paclitaxel weekly for 3 successive weeks with one week of rest. The cycle was repeated until objective disease progression or drug intolerance. Results: 35 pts were enrolled: 29 men and 6 women, age 62 (48∼74), 6 unresectable and 29 recurrent cancers, 13 with poorly differentiated phenotype and 20 with differentiated type, 22 PS0, 8 PS1, and 6 PS2. All front line treatments involved oral fluoropyrimidines and had been S-1 in 29, S-1/CDDP in 5, S-1/CPT-11 in one, and UFT in one patient. One pt declined to continue the treatment due to a Grade 2 taste disturbance after a single dose of paclitaxel, and 34 other pts were evaluable for response. Partial response was observed in 6 pts (response rate 17.6%). Median time to progression was 97 days and median survival time was 214 days (467 days among 22 PS0 patients). The incidence of ≥Grade 3 adverse events were as follows: neutropenia in 7 pts, leucopenia in 5, anemia in 4, anorexia in 4, neurological disorder, nausea, diarrhea, asthenia, and dyspnea in one. Conclusions: Activity of weekly paclitaxel was modest for pts with fluoropyrimidine-refractory gastric carcinoma, but median survival time was satisfactory, with a mild toxicity profile. Further phase II study under less strict eligibility criteria (e.g. inclusion of patients with elevated tumor markers or subjective evidence of clinical deterioration during the front line therapy as the sole indication of disease progression) is underway. No significant financial relationships to disclose.