A Phase I Trial of HDFL48(Weekly 48-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin) in Recurrent or Metastatic Colorectal Cancers
Colorectal cancer is one of the major in Taiwan.It caused 3128 deaths in 1999, and
represented the No.3 cancer killer in both male and female population of Taiwan.
Recently, evidence has accumulated that weekly, 24-hour infusion of high-dose 5-FU may
improve the response rate and survival time compared with 5-FU bolus regiment. In a
randomized multicenter trial of metastatic colorectal cancer, Kohne et al reported an
overall response rate of 44%and a median survival time of 16 months using a weekly-times-six
schedule of infusional 5-FU (2600mg/m2 24-hours infusion). In another randomized study for
advanced colorectal cancer, de Gramont et al reported a significantly better outcome in
patients treated by a similar schedule which combined "bolus plus infusional" 5-FU compared
to "bolus" 5-FU. These results suggest that 24-or 48-hour infusion of high-dose 5-FU is more
effective than the conventional bolus schedules.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine the maximum tolerated dose and dose limiting toxicity
Kun-Huei Yeh, M.D., Ph.D.
Department of Oncology, National Taiwan University hospital
Taiwan: Department of Health