Hepatic Arterial Infusion Using Codman Catheter/Synchromed Pump for the Treatment of Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma

Inclusion Criteria

• Histologically confirmed unresectable colorectal adenocarcinoma metastatic to the liver with no definitive clinical or radiographic evidence of extrahepatic disease. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. Up to 5 lung metastases are allowable, provided they are stable (or responding) in number and size for a minimum of 2-months of systemic chemotherapy and are amenable to stereotactic body radiation therapy (SBRT). OR Histologically confirmed unresectable intrahepatic cholangiocarcinoma, with presence of less than 70% liver involvement. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection and there is no distant metastatic disease * The definition of resection is complex and consensus about resectability is typically made by a multi-disciplinary tumor board comprising hepatobiliary surgeons and radiology. Generally, a minimum of two contiguous liver segments are required in the future liver remnant, although substantially more liver volume may be required in the setting of pre-existing liver disease or extensive preoperative chemotherapy-related hepatocellular injury
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Absolute neutrophil count >= 1,500/mcL (=< 14 days prior to study enrollment)
• Total bilirubin =< 1.5 mg/dL (=< 14 days prior to study enrollment)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 5 x institutional upper limit of normal (ULN) (=< 14 days prior to study enrollment)
• Platelets >= 100,000/mcL (=< 14 days prior to study enrollment)
• Creatinine < 1.5 mg/dL (=< 14 days prior to study enrollment)
• Hemoglobin (HGB) >= 9 g/dL (=< 14 days prior to study enrollment)
• International normalized ratio (INR) =< 1.5
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Prior chemotherapy is acceptable if last dose given >= 3 weeks prior to study enrollment
• Any investigational agent is acceptable if last dose administered >= 3 months before study enrollment
• Received a positive candidacy rating for hepatic arterial infusion pump (HAIP) chemotherapy as assessed by treating investigators via the modified Stanford Integrated Psychosocial Assessment for Transplant (mSIPAT) * Ratings indicating positive candidacy for HAIP chemotherapy are as follows: ** Patients with mSIPAT rating of “Excellent Candidate” are eligible ** Patients with mSIPAT rating of “Good Candidate” are eligible
• Eligibility status of patients rated “Minimally Acceptable Candidate for HAIP Chemotherapy” on the mSIPAT will be at the discretion of the treating investigators. Treating investigator confirmed eligibility of any patient who received a rating of “Minimally Acceptable Candidate” on the mSIPAT

Exclusion Criteria

• Presence of distant non-liver metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. For the colorectal carcinoma only: Up to 5 lung metastases are allowable, provided they are stable (or responding) in number and size for a minimum of 2-months of systemic chemotherapy and are amenable to SBRT
• Prior radiation to the liver, including external beam, SBRT, yttrium-90 (Y90). Prior radiation therapy to the pelvis is acceptable
• Active infection, hepatic encephalopathy
• Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis) are exclusions. Note that surgically-related ascites does not exclude the patient
• 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 prior to surgery)
• If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
• Patients with history or known presence of primary central nervous system (CNS) tumors, seizures not well-controlled with standard medical therapy. Patients with a history of stroke within 3 months or with substantial residual deficit, based on investigator discretion
• Serious or non-healing active wound, ulcer, or bone fracture
• Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen)
• Rating of “Poor/High Risk Candidate” on the modified Stanford Integrated Psychosocial Assessment of Transplant (mSIPAT) as assessed by treating investigator
• Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples include: active substance abuse, active severe ethanol (ETOH) abuse, etc.
• Inability to reliably commit to traveling to Lexington, Kentucky (KY) every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather