A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer

Exclusion Criteria

• •Investigational agents within 28 days prior to Day 1 of study
• •Chemotherapy within 4 weeks prior to Day 1 of study
• •Nitrosoureas, mitomycin-C within 6 weeks prior to Day 1 of study.
• •Prior treatment with sorafenib, gemcitabine or oxaliplatin
• •Prior history of peripheral neuropathy \> Grade 1 (e.g., diabetic neuropathy)
• •Pregnant or breast-feeding female
• •Patients with a history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to sorafenib, oxaliplatin or gemcitabine
• •Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
• •Cardiac disease: Congestive heart failure \> class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
• •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• •Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• •Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• •Known human immunodeficiency virus (HIV) infection and Hepatitis B and Hepatitis C.
• •Active clinically serious infection \> CTCAE Grade 2.
• •Arterial thrombotic/embolic events like myocardial infarct and cerebrovascular accident including transient ischemic attacks within the past 6 months.
• •Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
• •Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
• •Serious non-healing wound, ulcer, or bone fracture.
• •Evidence or history of bleeding diathesis or coagulopathy
• •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• •Use of St. John's Wort or rifampin (rifampicin).
• •Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities