Feasibility Pilot of Hepatic Arterial Infusion (HAI) Chemotherapy in a Rural Catchment Area, Using the Codman Tapered Vascular Catheter with the Synchromed II Pump, for Patients with Unresectable Colorectal Cancer Liver Metastases (CLM) or Unresectable

BACKGROUND: Complete resection offers the best chance of long-term survival of CLM and ICC, compared to systemic chemotherapy, which is rarely curative. HAI can downstage unresectable status via delivery of high-dose chemotherapy directly to liver metastases. Substantial data indicates that up to half of initially unresectable CLM become resectable, and similar trends in response rates are emerging in unresectable ICC. In April 2018, Cod man discontinued manufacture of the standard device used for HAI. As a workaround, a novel device combination of Medtronic Synchromed II pump with the Codman vascular catheter has been used off-label. Safety and feasibility of this combination is unknown, which limits HAI use that ultimately may attenuate survival rates from CLM and ICC. OBJECTIVES/HYPOTHESES: There is currently no available FDA-approved device for HAI. We aim to establish the safety of a novel combination of separately approved devices for HAI administration in unresectable CLM and ICC. We hypothesize this device combination is both safe and feasible within our primarily rural catchment area. To facilitate scientific study, we will also conduct pharmacokinetics on HAI administration concurrent with modern systemic chemotherapy. We will examine associations of toxicity with polymorphisms in the 5-FU metabolism genes and blood metabolite levels. We hypothesize that higher blood levels will be associated with certain polymorphisms, which may predict higher toxicity and possibly response.