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

Recurrent or Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00155558
• Other study ID #: 159I13
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: July 23, 2007
• Start date: March 2001
• Est. completion date: December 2005

Study information

• Verified date: November 2000
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Recurrent or Metastatic Colorectal Cancer

Intervention

Drug:
• 5-Fluorouracil, Leucovorin

Locations

Country	Name	City	State
Taiwan	Department of Oncology, National Taiwan University hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose and dose limiting toxicity		2000~2005
Secondary	response		2000~2005