A Phase I Trial of HDFL48 in Recurrent or Metastatic Colorectal Cancers

Phase 1

Completed

• Conditions: Recurrent or Metastatic Colorectal Cancer
• Interventions: Drug: 5-Fluorouracil, Leucovorin

• Registration Number: NCT00155558
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To determine the maximum tolerated dose and dose limiting toxicity of 5-FU and leucovorin with novel 48-hour infusion schedule, and to collect toxicity profile at different dose level of 5-FU/LV 48-hour infusion.

Detailed Description

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.

Study Timeline

• Status Verified: 2000-11
• Study Start: 2001-03
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Study Completion: 2005-12
• Last Update Submitted: 2007-07-23
• Last Update Posted: 2007-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 entry)
• Active infection exists
• Extensive liver disease or liver cirrhosis
• Patients who refuse Port-A catheter implantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	5-Fluorouracil, Leucovorin	-

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose and dose limiting toxicity	2000~2005

Secondary Outcome Measures

Name	Time	Method
response	2000~2005

Trial Locations

Locations (1)

Department of Oncology, National Taiwan University hospital; 🇨🇳 Taipei, Taiwan