Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155883
Status:
TERMINATED
Last Update Posted:
2008-08-18
First Post:
2005-09-09
Brief Title:
Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil Leucovorin HDFL for Inoperable Advanced or Metastatic Gastric Cancer
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil Leucovorin HDFL for Inoperable Advanced or Metastatic Gastric Cancer
Status:
TERMINATED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow a accrul due to many competitive trials
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of high-dose 5-FUleucovorin chemotherapy for patients with inoperable advanced gastric cancer
Detailed Description:
Gastric cancer is one of the leading causes of cancer death in Taiwan We have previously demonstrated that weekly 24-hour infusion of high-dose 5-fluorouracil 5-FU and leucovorin is an effective and well-tolerated regimen for patients with advanced gastric cancer Our in vitro and clinical studies suggested that long 24 hours or more infusion of 5-FUleucovorin may compared with the conventional bolus regimens enhance its anti-tumor activity in gastric cancer by prolonging suppression of thymidylate synthase the target enzyme of 5-FU cytotoxicity Docetaxel a mitotic inhibitor has good single-agent activity against gastric cancer with a tumor response rate around 20 to 24 Preliminary clinical data indicate that a biweekly administration of docetaxel will reduce the incidence of neutropenia and asthenia two most bothersome side effects of tri-weekly and weekly docetaxel respectively while maintaining its anti-tumor activity This phase II trial is designed to test the efficacy and toxicity of biweekly docetaxel and 24-hour infusion of high-dose 5-FUleucovorin as first-line therapy for patients with inoperable advanced gastric cancer
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