Downstaging of Unresectable Intrahepatic or Hilar Cholangiocellular Carcinoma by Selective Intra-arterial Floxuridine and Systemic Cisplatin and Gemcitabine. A Dose Finding Single Center Phase IIa Study

Fecha de inicio: 1 de abril de 2012

Inclusion criteria: Histologically or cytologically proven cholangiocellular carcinoma including gallbladder cancer. Non-resectable cholangiocellular carcinoma as judged within an interdisciplinary tumor-board including senior hepatobiliary surgeons. Non- resectability is based on insufficient remnant liver volume. Patient is not a candidate for liver transplantation WHO Performance Score 0 or 1 No extrahepatic tumor, as evaluated by PET/CT scan of the chest and the abdomen/pelvis with the exception of potentially resectable small lung nodules or hilar lymph node involvement. The assessment is done within 21 days before registration. Adequate liver function or kidney function tests, including any of the following: Bilirubin < 2 x ULN Aspartate-Aminotransferase (AST) < 5 x ULN Alanine-Aminotransferase (ALT) < 5 x ULN Alkaline phosphatase < 5 x ULN Estimated creatinine clearance > 60 ml/min (using the Cockcroft formula) Adequate hematological values: Hemoglobin > 80 G/L Leucocytes > 3.00 G/L, Neutrophils > 1.00 G/Ll Platelets > 100 G/L Signed written informed consent Patient age >/= 18 years Presentation of the case at the interdisciplinary tumor-board attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during the 12 months thereafter. A negative pregnancy test before inclusion into the trial is required for women < 50 years. Men who agree not to father a child during participation in the trial or during the 12 months thereafter. Patient compliance and geographic proximity allow proper staging and follow- up. Exclusion criteria: Anatomic variant in arteriogram which prevents selective delivery of the chemotherapy to the liver Life expectancy < 3 months Severe medical or psychiatric co-morbidity prohibiting the planned treatment or the giving of informed consent Any man or woman of childbearing age in case of inadequate contraception Pregnancy or breastfeeding woman Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs. Treatment in clinical trial within 30 days prior to trial entry. Active heart disease defined as congestive heart failure > NYHA class 2 Past or current history (within the last 2 years prior to treatment start) of other malignancies except basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix Inability or unwillingness to comply with the study protocol