Trials / Completed
CompletedNCT00504192
A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Soonchunhyang University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine and Oxaliplatin | gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2008-03-01
- Completion
- 2009-03-01
- First posted
- 2007-07-19
- Last updated
- 2014-05-20
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00504192. Inclusion in this directory is not an endorsement.