Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504192
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2007-07-18
Brief Title:
A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2009-05
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:
The role of systemic chemotherapy in advanced biliary tract cancer BTC is known to be very limited although various single-agent or combination therapies had been tested However there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several studies A GERCOR study showed the promising result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced BTC Therefore this phase II trial was planned to investigate efficacy and toxicity of combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with inoperable BTC in Korea
Detailed Description:
Treatment scheme
Gemcitabine 1000 mgm2d IV D1 as a 10mgm2min Oxaliplatin 85 mgm2d IV D2 as a 2 hours infusion
Each cycle is repeated every 2 weeks
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity Subjects will be treated for at least 4 cycles unless there is documented disease progression unacceptable adverse events or withdrawal of consent
Gemcitabine 1000 mgm2d IV D1 as a 10mgm2min Oxaliplatin 85 mgm2d IV D2 as a 2 hours infusion
Each cycle is repeated every 2 weeks
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity Subjects will be treated for at least 4 cycles unless there is documented disease progression unacceptable adverse events or withdrawal of consent
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