XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy

Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy

Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.

XELOX

• Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
• Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).

Inclusion Criteria:

1. age ≥ 18
2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
3. unresectable or metastatic
4. progression after treatment with first line gemcitabine-based chemotherapy
5. ECOG performance status of 0~2
6. measurable or evaluable lesion per RECIST 1.1 criteria
7. adequate marrow, hepatic, renal and cardiac functions

Exclusion Criteria:

1. severe co-morbid illness or active infections
2. pregnant or lactating women
3. History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
4. active CNS metastases not controllable with radiotherapy or corticosteroids
5. known history of hypersensitivity to study drugs