A phase II study of leucovorin, 5-FU and docetaxel combination chemotherapy in patients with inoperable or postoperative relapsed gastric cancer.

Objective: To estimate the effect and toxicity of bimonthly low-dose leucovorin (LV) and fluorouracil (5-FU) bolus plus continuous infusion(LV5FU2) with docetaxel combination chemotherapy in patients with inoperable or postoperative relapsed gastric cancer.

Methods: Total 27 patients are enrolled in this study. LV 20 mg/m(2) (bolus), 5FU 400 mg/m(2) (bolus), 5-FU 600 mg/m(2) (24-hour continuous infusion) on day 1, 2, 15, and 16, docetaxel 60 mg/m(2) (1-hour infusion) on day 15 every 4 weeks.

Results: Total of 141 cycles were administered and response rate were 36.8% with 2 complete response (10.5%) and 5 partial response (26.3%) in 19 evaluable patients. The median response duration is 8.1 months (95% CI, 4.0 approximately 12.1). The median progression-free survival time is 6.7 months (95% CI, 5.0 approximately 8.5) and the median overall survival time is 11.9 months (95% CI, 4.8 approximately 19.1). The grade 3-4 toxicity of neutropenia (24.8%) and anemia (11.3%), neutropenic fever (2.8%) is observed. The grade 1 toxicity of injection site reaction is observed all patients and the grade 1-2 toxicity of alopecia is observed 60%.

Conclusions: LV5FU2 with docetaxel combination chemotherapy is effective and tolerable in patients with inoperable or postoperative relapsed gastric cancer.