Clinical trial NCT03069950 (phase 2, status: withdrawn)
Conditions: colorectal adenocarcinoma metastatic to the liver
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: floxuridine (fudr), irinotecan (cpt-11), fluorouracil, panitumumab, dexamethasone, leucovorin
SMILES: OC[C@H]1O[C@H](C[C@@H]1O)N1C=C(F)C(=O)NC1=O, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    lack of accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  History of histologically confirmed colorectal adenocarcinoma metastatic to the liver
             with no clinical or radiographic evidence of extrahepatic disease. Confirmation of
             diagnosis must be performed by the enrolling institution.

          -  Patients must have a primary L sided colorectal cancer, (at or distal to the splenic
             flexure)

          -  Confirmed RAS/RAF wild type tumor. Paraffin-embedded tumor tissue obtained from the
             primary tumor or metastasis

          -  Have received prior treatment for metastatic disease with oxaliplatin-based regimen
             and either

               -  Had disease progression OR

               -  Had stable disease OR

               -  Discontinued oxaliplatin due to neuropathy

          -  Patients must meet the following criteria for unresectability as determined by two
             hepatobiliary surgeons and one radiologist:

               -  When a margin negative resection would require resection of all three hepatic
                  veins, both portal veins, or the retrohepatic vena cava.

               -  Requiring a resection that leaves less than 2 hepatic segments (not including the
                  caudate lobe) behind with adequate arterial/portal inflow, venous outflow and
                  biliary drainage. **

                  **A patient is considered resectable if the procedure includes a minor wedge or
                  thermo-ablation encompassing 10% or less of the volume of the remaining 2
                  segments.

               -  Patient"s liver metastases must comprise <70% of the liver parenchyma. All
                  patients must be clinically fit to undergo surgery as determined by the
                  pre-operative evaluation

          -  Lab values within 14 days prior to enrollment/randomization:

               -  WBC ≥ 3.0 K/uL

               -  ANC > 1.5 K/uL

               -  Platelets ≥ 100,000/uL

          -  Renal function (≤ 10 days prior to enrollment/randomization) °Creatinine ≤ 1.5 mg/dL
             or creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method as
             follows:

        Cockcroft-Gault method as follows:

          -  Male creatinine clearance = (140 -age in years) x (weight in Kg) / (serum Cr in mg/dl
             x 72)

          -  Female creatinine clearance = (140 - age in years) x (weight in Kg) x 0.85 / (serum Cr
             in mg/dl x 72) (use of creatinine clearance per protocol based on chemotherapy
             regimen)

               -  Hepatic function, as follows: (≤ 10 days prior to enrollment/randomization)

          -  Total Bilirubin ≤ 1.5 mg/dl

               -  Calcium ≥ lower limit of normal (≤ 48 hours prior to enrollment/randomization)

               -  KPS ≥ 60% (ECOG (or Karnofsky) performance status (preferably 0 or 1/≥ 60% for
                  Karnofsky))

        Exclusion Criteria:

          -  Patients < 18 years of age

          -  Patients who have received more than one chemotherapy regimen for metastatic disease

          -  Patients who are chemotherapy naïve

          -  Prior radiation to the liver (Prior radiation therapy to the pelvis is acceptable if
             completed at least 4 weeks prior to registration)

          -  Active infection

             °Active infection includes patients with positive blood cultures

          -  Prior treatment with HAI FUDR

          -  Prior TACE

          -  Female patients who are pregnant or lactating - or planning to become pregnant within
             6 months after the end of the treatment (female patients of child-bearing potential
             must have negative pregnancy test ≤ 72 hours before enrollment and randomization, and
             must have a negative pregnancy test ≤ 72 hours prior to treatment start)

          -  If a patient has any serious medical problems which may preclude receiving this type
             of treatment

          -  Patients with history or known presence of primary CNS tumors, seizures not
             well-controlled with standard medical therapy, or history of stroke will also be
             excluded.

          -  Serious or non-healing active wound, ulcer, or bone fracture

          -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
             evidence of interstitial lung disease on baseline chest CT scan

          -  Patients who have a diagnosis of Gilbert"s disease

          -  History of other malignancy, except:

               1. Malignancy treated with curative intent and with no known active disease present
                  for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by
                  the treating physician

               2. Adequately treated non-melanomatous skin cancer or lentigo maligna without
                  evidence of disease

               3. Adequately treated cervical carcinoma in situ without evidence of disease