Clinical trial NCT01926236 (phase 3, status: completed)
Conditions: biliary tract cancer, gallbladder cancer, cholangiocarcinoma, ampullary cancer
ICD codes: C24.9, C24.8, C23, D37.6, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: l-folinic acid, 5 fu, oxaliplatin
SMILES: NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, FC1=CNC(=O)NC1=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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 criteria:

          -  Incomplete recovery from previous therapy or unresolved biliary tree obstruction
             (includes ongoing neuropathy of grade >1 from cisplatin)

          -  Any evidence of severe or uncontrolled systemic diseases which, in the view of the
             investigator, makes it undesirable for the patient to participate in the trial

          -  Evidence of significant clinical disorder or laboratory finding which, in the opinion
             of the investigator makes it undesirable for the patient to participate in the trial

          -  Any patient with a medical or psychiatric condition that impairs their ability to give
             informed consent

          -  Any other serious uncontrolled medical conditions

          -  Clinical evidence of metastatic disease to brain

          -  Any pregnant or lactating woman

          -  Clinically significant cardiovascular disease. [i.e. active; or <12 months since e.g.
             cerebrovascular accident, myocardial infarction, unstable angina, New York Heart
             Association (NYHA) grade II or greater congestive heart failure, serious cardiac
             arrhythmia requiring medication, uncontrolled hypertension].

             **Hypertension grading of ≥ 3 is an exclusion criteria (CTCAE v4.03). However,
             patients who have controlled hypertension with medication and/or diet may be included
             at the investigator's discretion. (This should be noted in the medical history section
             of the CRF).

          -  Patients must not have a history of other malignant diseases within the last 5 years
             (other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the
             uterine cervix).