Phase I trial of ftorafur combined with mitomycin C or methyl-CCNU in gastrointestinal cancers.

Twenty-five patients with disseminated gastrointestinal malignancies were treated in a phase I study with a combination of ftorafur and mitomycin C or florafur and methyl-CCNU. Most patients had been heavily treated previously. Gastrointestinal, central nervous system, and marrow toxicity were manageable. Tumor regression was noted in five of 25 patients. A large-scale phase II study in untreated patients with gastrointestinal malignancies appears indicated with a combination of these agents.