Dose climbing trial of lobaplatin combined with 5-FU/CF in patients with advanced gastric or colorectal cancer

Objective To evaluate the tolerability and toxic reaction of the combination of fluorouracil,leucovorin and different dose lobaplatin for patients with advanced gastric or colorectal cancer and investigate the safe dose of lobaplatin in the combined chemotherapy.Methods From low dose group to high dose group,each one had 3 patients at least.Primary group received 25mg/m2of lobaplatin which was administrated at d1 of chemotherapy.The dose of lobaplatin would increase gradually until MTD or 50mg/m2.Results Eighteen patients were enrolled in the clinical research that included 6 groups.The highest dose of loba platin was 50mg/m2,and we did not obtain MTD.The major toxicities were anemia and neutropenia,other related toxicities included nausea,vomiting and diarrhea.No grade Ⅲ-Ⅳ toxicity was observed.Conclusion The combination of lobaplatin,leucovorin and fluorouracil shows a favorable toxicity profile in patients with advanced gastric or colorectal cancer.The combination regimen of 45mg/m2 lobaplatin,leucovorin and fluorouracil was recommended in further clinical study.