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A Phase I Trial of HDFL48(Weekly 48-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin) in Recurrent or Metastatic Colorectal Cancers

Phase 1
18 Years
Not Enrolling
Recurrent or Metastatic Colorectal Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

- Pathologically confirmed recurrent or metastatic colorectal adenocarcinoma

- Patients are indicated for 5-FU (1st-line after recurrence/metastasis), OR have
failed 5-FU ,treatment with other schedules

- At least one bi-dimensionally measurable lesion(s)

- Previous C/T, R/T >= 4 weeks

- KPS > 50%

- Age >= 18 years

- Fasting TG > 70 mg/dL (within 7 days)

- WBC >= 3,000/uL or ANC >= 1,500/uL

- Plt >= 75,000/uL

- Cre<= 1.5 mg/dL

- Proteinuria < 1+

- Normal T-bil

- AST/ ALT <= 3.5-fold of ULN

Exclusion Criteria:

- Concomitant anticancer therapy or radiotherapy

- CNS metastasis

- Pregnant women

- Patients who have second malignancy

- Symptomatic heart disease (significant arrhythmia, CHF or MI within 3 months of

- Active infection exists

- Extensive liver disease or liver cirrhosis

- Patients who refuse Port-A catheter implantation

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine the maximum tolerated dose and dose limiting toxicity

Outcome Time Frame:


Principal Investigator

Kun-Huei Yeh, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, National Taiwan University hospital


Taiwan: Department of Health

Study ID:




Start Date:

March 2001

Completion Date:

December 2005

Related Keywords:

  • Recurrent or Metastatic Colorectal Cancer
  • Colorectal Cancer, Maximum tolerated dose
  • Colorectal Neoplasms