In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.

1. brief enrollment criteria

   • histological confirmed
   • refractory to first line gemcitabine plus cisplatin
   • fit for chemotherapy

2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

   B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

3. randomization - stratified by tumor site and performance status

Inclusion Criteria:

• 20 years and older
• pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
• initially inoperable or recurrent
• ECOG 0-2
• as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
• evaluable or measurable lesion
• within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL, neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT < UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)
• patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage

Exclusion Criteria:

• other cancer history
• pregnant or lactating
• uncontrolled medical condition such as infection or cardiovascular disease
• hypersensitivity to experimental drugs
• uncontrolled CNS metastasis, psychologic problem