Phase II trial of ftorafur with mitomycin C versus ftorafur with methyl-CCNU in untreated colorectal cancer.
In an attempt to substitute ftorafur for burdensome 5-fluorouracil (5-FU) infusions, 52 previously untreated patients were randomized to receive ftorafur with either mitomycin C or methyl-CCNU. Ftorafur was administered monthly as a 2-hour infusion daily x 5 days. Mitomycin C and methyl-CCNU were repeated every 8 weeks. A response rate of 27% (seven responses among 26 patients) was demonstrated on the mitomycin C arm compared to a response rate of 15% (four responses among 26 patients) on the methyl-CCNU arm (P = 0.25). There was no significant difference in the median survival between treatment arms. Central nervous system toxicity occurred in greater than 30% of the patients and appeared to be the limiting factor with ftorafur administration. Alternate schedules of ftorafur should be explored since there appears to be little advantage of a daily ftorafur schedule over conventional 5-FU infusions.
D000230:Adenocarcinoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003110:Colonic Neoplasms / Q000188:drug therapy*; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008937:Mitomycins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009607:Nitrosourea Compounds / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000188:drug therapy*; D012673:Semustine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D008937:Mitomycins; D009607:Nitrosourea Compounds; D012673:Semustine; D005641:Tegafur; D005472:Fluorouracil