Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155558
Status:
COMPLETED
Last Update Posted:
2007-07-25
First Post:
2005-09-09
Brief Title:
A Phase I Trial of HDFL48 in Recurrent or Metastatic Colorectal Cancers
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Phase I Trial of HDFL48Weekly 48-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin in Recurrent or Metastatic Colorectal Cancers
Status:
COMPLETED
Status Verified Date:
2000-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-FULV 48-hour infusion
Detailed Description:
Colorectal cancer is one of the major in TaiwanIt caused 3128 deaths in 1999 and represented the No3 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 44and a median survival time of 16 months using a weekly-times-six schedule of infusional 5-FU 2600mgm2 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
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 44and a median survival time of 16 months using a weekly-times-six schedule of infusional 5-FU 2600mgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None