Status:
COMPLETED
Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Unresectable, Metastatic Biliary Tract Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary tract carcinoma.
Detailed Description
This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.
Eligibility Criteria
Inclusion
- age ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract
- unresectable or metastatic
- ECOG performance status of 0\~2
- measurable or evaluable lesion per RECIST criteria
- adequate marrow, hepatic, renal and cardiac functions
- no prior chemotherapy or molecularly targeted therapy for the advanced biliary carcinoma (prior adjuvant chemotherapy will be allowed if administered ≥ 6 months from the study entry)
- provision of a signed written informed consent
Exclusion
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
- known history of hypersensitivity to study drugs
- prior exposure to EGFR tyrosine kinase inhibitor
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT01149122
Start Date
January 1 2009
End Date
June 1 2012
Last Update
May 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Seoul, South Korea