Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma
- Sponsor
- Samsung Medical Center
- Study ID
- NCT01149122
- Phase
- PHASE3
- Status
- Completed
Conditions
- Unresectable, Metastatic Biliary Tract Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Gemcitabine/Oxaliplatin — DRUGGEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks
- Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) — DRUGGEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd
Study Details
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.
Key Dates
- First listed
- Jun 23, 2010
- Start date
- Jan 31, 2009
- Status verified
- Jan 2012
- Primary completion
- Jan 31, 2012
- Completion
- Jun 30, 2012
Study Design
- Enrollment
- 266 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Gemcitabine/Oxaliplatin with Erlotinib
- Active Comparator: Gemcitabine/Oxaliplatin without Erlotinib
Primary Outcome Measure
Progression Free Survival [ Time Frame: every 6 weeks ]