UFT/leucovorin combined with mitomycin-C in metastatic colorectal Ca.

UFT is an investigational agent that may be useful treatment for colorectal carcinoma and other cancers for which fluorinated pyrimidines are a useful treatment. The combination of continuous-infusion fluorouracil (5-FU) with leucovorin and mitomycin-C can significantly delay recurrence and may prolong life. UFT may be an attractive alternative to continuous-infusion 5-FU because three-times-daily administration of UFT results in comparable concentrations of 5-FU in the plasma. Recently, a clinical trial investigated the combination of UFT and mitomycin-C and found it demonstrated significant synergy in the treatment of advanced colorectal cancer. We describe the design of a phase II study to investigate the safety and efficacy of UFT/leucovorin combined with mitomycin-C in a larger group of previously untreated patients with metastatic colorectal cancer.