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.
This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks
GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd
Samsung Medical Center
Seoul, South Korea
Progression Free Survival
Time frame: every 6 weeks
Safety profile
Time frame: 24 months
Response rate
Time frame: 24 months
Duration of response
Time frame: 24 months
Time to progression
Time frame: 24 months
Overall survival
Time frame: 24 months
Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses
Time frame: 24 months
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