Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer

Inclusion Criteria:

* Patients must have histologically confirmed, advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, hilum bile duct, extrahepatic bile duct and gallbladder), except ampulla vater cancer or combined hepatocholangiocarcinoma.
* presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be≥15 mm in the short axis.
* Patients must have no history of prior chemotherapy for Biliary Tract Cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
* Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease.
* Patients' baseline Eastern Cooperative Oncology Group (ECOG)performance status must be less than or equal 1.
* Patients' life expectancy must be 12 weeks or greater.
* Patients' age must be more than or equal 20 years old.
* Patients must have adequate bone marrow function, defined as white blood cell (WBC) count ≥3,500/ul, absolute neutrophil count (ANC) 1,500/ul, and platelet count ≥100,000/ul.
* Patients must have adequate liver function and adequate renal function, defined as the following: serum alanine (ALT) 3 times upper normal limit, serum total bilirubin level less than or equal 2.0 mg/dL, and creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockcroft-Gault formula).
* Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.
* Patients must agree to have indwelling venous catheter implanted.
* Women or men of reproductive potential should agree to use an effective contraceptive method.
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion Criteria:

* Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy.
* Patients with central nervous system metastasis
* Patients with active infection
* Pregnant or breast-nursing women
* Patients with active cardiopulmonary disease or history of ischemic heart disease
* Patients who have peripheral neuropathy \> Grade I of any etiology, presence of grade 2 or above ascites or pleural effusion, or ≥ grade 2 of diarrhea.
* Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
* Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment
* Patients who are under biologic treatment for their malignancy