Clinical trial NCT02487277 (phase 2, status: terminated)
Conditions: adenocarcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: pegph20, gemcitabine, nab-paclitaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [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
Reason stopped: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Greater than or equal to 18 years old

          -  Histologically confirmed pancreatic adenocarcinoma

          -  Borderline resectable disease

          -  Performance status of Eastern Cooperative Oncology Group (ECOG) of 0-1

          -  Therapy naïve

          -  Evaluable disease with either:

          -  RECIST-defined measurable disease

          -  An elevated serum CA19-9 >100 u/ml

          -  Adequate organ function including:

          -  Bone marrow: Absolute Neutrophil Count (ANC) ≥1500/mm3, platelets ≥100,000/mm3 and
             hemoglobin ≥ 9 g/dL

          -  Hepatic: Serum total bilirubin ≤1.5 x upper limit of normal (ULN), alanine
             aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) and aspartate
             aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5 x ULN.

          -  Renal: Serum creatinine (sCr) ≤ 1.5 x ULN, or creatinine clearance (Ccr) ≥ 40 mL/min
             as calculated by the Modified Cockcroft-Gault formula.

          -  Peripheral neuropathy < grade 2

          -  Alkaline phosphatase ≤ 2 times the ULN unless bone metastasis is present in the
             absence of liver metastasis

        Exclusion Criteria:

          -  Age younger than 18 years old

          -  Locally advanced or metastatic disease

          -  Known allergy to hyaluronidase

          -  Contraindications to prophylactic dose low molecular weight heparin (LMWH) , including

          -  Patients with recent gastrointestinal bleeding

          -  History of heparin induce thrombocytopenia on LMWH

          -  Subjects with previous severe hemorrhagic events on LMWH

          -  Known contraindications to heparin including:

          -  Recent central nervous system bleed, intracranial or spinal lesion at high risk for
             bleeding

          -  Active bleeding (major): more than 2 units transfused in 24 hours

          -  Spinal anesthesia/lumbar puncture within the past month

          -  Chronic, clinically significant measurable bleeding > 48 hours

          -  Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis)

          -  Recent major operation at high risk for bleeding

          -  Underlying hemorrhagic coagulopathy High risk for falls (head trauma)

          -  Presence of metal biliary stents (plastic biliary stents are not an exclusion)

          -  Known status of HIV which is not well-controlled at the time of study eligibility

          -  Untreated Hepatitis B infection

          -  Active infection or antibiotics within 48 hours prior to study

          -  Currently active second primary malignancy or history of malignancy less than 5 years
             prior to the time of study eligibility (Patients with history of skin cancers
             excluding melanoma will be eligible for participation).

          -  Serious medical comorbidities such as New York Heart Association Class III/IV cardiac
             disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12
             months.

          -  Patients with aneurysm clips, ear implants, spinal nerve stimulators, pacemaker,
             shrapnel or any other metal in their body (contraindication for MRI scans)

          -  Known, existing uncontrolled coagulopathy. Patients who have had a venous
             thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring
             anticoagulation are eligible IF: they are appropriately anticoagulated and have not
             had a Grade 2 or greater bleeding episode in the 3 weeks before Day 1.

          -  Current use of warfarin (patients will be eligible if warfarin is discontinued and
             low-molecular weight heparin is used instead).

          -  Intolerance to dexamethasone

          -  Prior history of cerebrovascular accident or transient ischemic attack, or
             pre-existing carotid artery disease.

          -  Known pregnancy, nursing women or positive pregnancy test.

          -  Any condition that would preclude informed consent, consistent follow-up and
             compliance for the study participation.