A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
Treatment scheme
:Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d 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.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma
Dae Sik Hong, professor
Principal Investigator
Soonchunhyang University Bucheon Hospital
South Korea: Institutional Review Board
SCH-GO-BTC1
NCT00504192
September 2006
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