Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201305
Status:
COMPLETED
Last Update Posted:
2009-04-01
First Post:
2005-09-13
Brief Title:
Gemcitabine Plus High-Dose 5-FuLeucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
Prospective Phase II Randomized Trial-Weekly Gemcitabine Plus High-Dose 5-Fluorouracil Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FUleucovorin infusion HDFL for patients with advanced or metastatic carcinoma of the biliary tract The primary endpoint is patients response and the secondary endpoints are chemotherapy-related toxicity time to disease progression and overall survival
Detailed Description:
5-FU has been the mainstay of chemotherapeutic agents for gastrointestinal malignancies The use of weekly 24-hour infusion of HDFL produces high clinical response in a variety of cancers including colorectal gastric and breast cancers with minimal chemotherapy-related toxicity Gemcitabine is a synthesized deoxycytidine analogue that is metabolized to dFdCTP in tumor cells and results in inhibition of DNA synthesis and depletion of normal cellular nucleotide pool It has been shown to be active in the treatment of pancreatic cancer and non-small cell lung cancer Since the biliary tract and the pancreas share a common embryonic origin and cancers from both sites are characterized by resistance to most chemotherapeutic agents we postulate that gemcitabine may also be effective for cancer of the biliary tract In our institution we have devised a regimen of weekly gemcitabine and 24-hour infusion of HDFL for patients with advanced or metastatic pancreatic adenocarcinoma In 18 evaluable patients 2 achieved a partial response and 3 minor response The median duration of response was 4 months and the treatment-related toxicity was acceptable
The eligibility criteria are patients with advanced or metastatic carcinoma of the biliary tract who are not candidates for curative surgical treatment good performance status no prior chemotherapy clinical measurable tumor good organ function and good compliance Each cycle of chemotherapy consists of 4 weeks On days 1 8 and 15 gemcitabine will be given by 30-minute intravenous infusion and 5-FU and leucovorin by 24-hour continuous intravenous infusion The dose of gemcitabine will be 1000 mgm2 The doses of 5-FU will be 2000 mgm2 and leucovorin 300 mgm2 Treatment will continue until disease progresses or prohibitive toxicity develops For patients with complete response CR chemotherapy will continue for 3 additional courses after the documentation of CR Estimated time for patient accrual is 3 years
The eligibility criteria are patients with advanced or metastatic carcinoma of the biliary tract who are not candidates for curative surgical treatment good performance status no prior chemotherapy clinical measurable tumor good organ function and good compliance Each cycle of chemotherapy consists of 4 weeks On days 1 8 and 15 gemcitabine will be given by 30-minute intravenous infusion and 5-FU and leucovorin by 24-hour continuous intravenous infusion The dose of gemcitabine will be 1000 mgm2 The doses of 5-FU will be 2000 mgm2 and leucovorin 300 mgm2 Treatment will continue until disease progresses or prohibitive toxicity develops For patients with complete response CR chemotherapy will continue for 3 additional courses after the documentation of CR Estimated time for patient accrual is 3 years
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