Clinical trial NCT02124369 (phase 2, status: terminated)
Conditions: pancreatic adenocarcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: abraxane, gemcitabine
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with borderline unresectable advanced pancreatic adenocarcinoma, defined as
             Category 2 by central radiological review.

          -  Aged 18 years or over at the time of signing the informed consent form.

          -  Documented histological or cytological diagnosis of pancreatic ductal adenocarcinoma.

          -  ECOG performance status 0-1.

          -  Life expectancy of at least 12 weeks.

          -  Willing and able to comply with scheduled visits, treatment plans, laboratory tests
             and other study procedures.

          -  Adequate haematological function defined by:

          -  Absolute neutrophil count (ANC) ≥1,500 cells/mm3 (1.5 x 109/L).

          -  Haemoglobin ≥8.0 g/dL (80 g/L) (may be increased to this level with transfusion as
             long as there is no evidence of active bleeding).

          -  Platelets ≥100x 109/L

          -  Adequate renal function defined by serum creatinine≤1.5 x ULN or calculated creatinine
             clearance by Cockcroft-Gault of ≥50 ml/min.

          -  Adequate hepatic function defined by:

          -  Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 x upper
             limit of normal (ULN)

          -  Total bilirubin ≤1.5 x ULN

          -  Patients may have endoscopic or radiologic stenting to treat biliary obstruction. If
             so, bilirubin must return to ≤1.5 x ULN prior to enrolment.

          -  Received no prior therapy for their disease.

          -  Measurable disease by RECIST 1.1 criteria. Tumour assessments and measurements must be
             done within 28 days before the patient receives the first dose of ABX/GEM.

          -  All Women of Child Bearing Potential (WoCBP) and all sexually active male patients
             must agree to use effective contraception methods throughout the study and for 6
             months after the final dose of trial drug.

        Exclusion Criteria:

          -  Patients with metastatic PDAC, or disease which is amenable to resection with curative
             intent. These include tumours which are defined as Category 1 or 3 by central
             radiological review.

          -  Other invasive malignancies diagnosed within the last 5 years, with the exceptions of
             adequately treated localized cured prostate cancer, in situ carcinoma of the cervix
             uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have
             undergone potentially curative therapy for a prior malignancy, have no evidence of
             that disease for three years or more and are deemed at negligible risk for recurrence,
             are eligible for the trial.

          -  Known allergy or hypersensitivity to ABX or GEM.

          -  Routine use of oral anti-oxidant supplements: beta-carotene, selenium, lutein,
             zeaxanthin, lycopene, pycnogenol, fernblock, omega-3S, vitamin C, vitamin E,
             astaxanthin. If recent use, a washout period of 5 half-lives is required.

          -  Patients with pre-existent ischemic heart disease particularly those under active
             treatment for coronary disease, will be excluded from Sonuvue dynamic contrast
             enhanced ultrasound investigation due to sporadic reports of cardiac ischemia in this
             population. They will be eligible for the rest of the study, as long as their cardiac
             status does not preclude surgery.

          -  Significant acute or chronic medical or psychiatric condition, disease or laboratory
             abnormality which in the judgment of the Investigator would place the patient at undue
             risk or interfere with the study. Examples include, but are not limited to:

          -  Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep
             vein thrombosis) requiring anticoagulation who are not appropriately anti-coagulated
             or have had a NCI CTCAE (version 4.0) Grade 2 or greater bleeding episode in the 4
             weeks before Day 1.

          -  Patients taking warfarin, unless it is possible for the patient to be switched to a
             low molecular weight heparin for the duration of the study

          -  Patients with a significant history of stroke, unstable angina, myocardial infarction,
             or ventricular arrhythmia requiring medication or mechanical control within the last 6
             months.

          -  Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute
             hepatitis B, or hepatitis C.

          -  Known infection with HIV.

          -  Women, who are pregnant, plan to become pregnant or are lactating (during the study or
             for up to 6 months after the last dose).