Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers

Inclusion Criteria: * Histologically / cytologically verified, non-resectable or recurrent / metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma. * Patients must have failed no more than one prior course of chemotherapy (gemcitabine and cisplatin) with clear evidence of disease progression. * ECOG performance status 0-1. * Age \>=18 years and life expectancy \>3 months. * Adequate renal function with serum urea and serum creatinine \< 1.5 times upper limit of normal (ULN) and creatinine clearance \>= 30ml/min * Adequate haematological function: Hb \>= 100g/l, WBC \>= 3.0 x 10\*9/L, ANC \>= 2 x 10\*9/L, platelet count \>= 100 x 10\*9/L * Adequate liver function: total bilirubin \< 60 μmol/L and ALP, along with AST and/or ALT ≤ 5 x ULN * Adequate biliary drainage, with no evidence of ongoing infection (patients on maintenance antibiotics are eligible when acute sepsis has resolved). * Women of child bearing age must have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 4 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy * Men must be willing to use an adequate method of contraception during chemotherapy and until 6 months after chemotherapy * Patients must have given written informed consent * Patients must be randomised and those allocated chemotherapy must start treatment within 6 weeks of diagnosis of disease progression Exclusion …