Ignite Creation Date:
2024-05-05 @ 10:44 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01171755
Status:
TERMINATED
Last Update Posted:
2014-05-21
First Post:
2010-07-27
Brief Title:
Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Phase II Study of Gemcitabine and TS-1 in Patients With Previously Untreated Metastatic or Recurrent Biliary Tract Cancer
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The objective response rate by more than two people are confirmed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GetBil
Brief Summary:
In current study we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy in advanced BTC
Detailed Description:
At present surgery is the only curative treatment option for biliary tract cancer BTC However less than 25 of patients are resectable at presentation with high relapse rates after surgery Because of the low incidence and heterogeneity of BTC clinical trials are difficult to conduct in these patients hampering the evaluation of optimal chemotherapy regimens Owing to the lack of randomized phase III studies there is no standard regimen for palliative chemotherapy of GBC and CC But the exploration of an optimal regimen for standard first-line chemotherapy for BTC is imperative in order to improve survival in these patients
Gemcitabine has demonstrated antitumor activity as monotherapy in phase II trials in BTC patients with response rates ranging from 22 to 36 2001 Proc Am Soc Clin Oncol 20A626 2001 J Clin Oncol 19204089-4091 2001 Ann Oncol 122183-186
As with most gastrointestinal tumors 5-fluorouracil 5-FU is the most studied drug as a single agent or a combination in different dosages and schedules with response rates of 10-20 and with median survival of 7-9 months in BTC 2005 Cancer 103111-118 2001 Clin Cancer Res 73375-3380
The combination of gemcitabine and fluoropyrimidine in biliary cancers is worthy of further evaluation The toxicity profiles of these agents are known to be non-overlapping and combinations have been well tolerated Oral fluoropyrimidines are considered to be an alternative to conventional protracted 5-FU infusion as far as they provide comparable efficacy and compliance
S-1 is oral fluoropyrimidine preparation developed by Taiho Pharmaceutical Co Ltd Tokyo Japan that combines tegafur with two 5-FU modulators 5-chloro-2 4-dihydroxypyridine CDHP and potassium oxonate Oxo in a molar ratio of 1041 Tegafur a prodrug of 5-FU is converted to 5-FU mainly in liver and tumor cells CDHP a reversible inhibitor of dihydropyrimidine dehydrogenase suppresses the degradation of 5-FU thereby maintaining high concentrations of 5-FU in plasma and tumor cells CDHP also decreases cardiotoxic and neurotoxic effects by reducing the production of F-b-alanine FBAL the main catabolite of 5-FU Several phase II trials showed that TS-1 monotherapy or combination with CDDP paclitaxel or irinotecan was effective palliative treatment option for advanced gastric cancer and colorectal cancer
In current study we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy in advanced BTC
Gemcitabine has demonstrated antitumor activity as monotherapy in phase II trials in BTC patients with response rates ranging from 22 to 36 2001 Proc Am Soc Clin Oncol 20A626 2001 J Clin Oncol 19204089-4091 2001 Ann Oncol 122183-186
As with most gastrointestinal tumors 5-fluorouracil 5-FU is the most studied drug as a single agent or a combination in different dosages and schedules with response rates of 10-20 and with median survival of 7-9 months in BTC 2005 Cancer 103111-118 2001 Clin Cancer Res 73375-3380
The combination of gemcitabine and fluoropyrimidine in biliary cancers is worthy of further evaluation The toxicity profiles of these agents are known to be non-overlapping and combinations have been well tolerated Oral fluoropyrimidines are considered to be an alternative to conventional protracted 5-FU infusion as far as they provide comparable efficacy and compliance
S-1 is oral fluoropyrimidine preparation developed by Taiho Pharmaceutical Co Ltd Tokyo Japan that combines tegafur with two 5-FU modulators 5-chloro-2 4-dihydroxypyridine CDHP and potassium oxonate Oxo in a molar ratio of 1041 Tegafur a prodrug of 5-FU is converted to 5-FU mainly in liver and tumor cells CDHP a reversible inhibitor of dihydropyrimidine dehydrogenase suppresses the degradation of 5-FU thereby maintaining high concentrations of 5-FU in plasma and tumor cells CDHP also decreases cardiotoxic and neurotoxic effects by reducing the production of F-b-alanine FBAL the main catabolite of 5-FU Several phase II trials showed that TS-1 monotherapy or combination with CDDP paclitaxel or irinotecan was effective palliative treatment option for advanced gastric cancer and colorectal cancer
In current study we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy in advanced BTC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 82-02-3410-0914 | None | None | None |