This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
Patient must be >= 18 years of age
Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).
Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes).
NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.
None
Parallel
Bevacizumab
Biological/VaccineGiven IV
Capecitabine
DrugGiven PO
Cetuximab
Biological/VaccineGiven IV
Computed Tomography
Procedure/SurgeryUndergo SPECT/CT and/or CT
Floxuridine
DrugGiven via HAI pump
Fluorouracil
DrugGiven IV
Implantation
Procedure/SurgeryUndergo surgery to place the HAI pump
Intrahepatic Infusion Procedure
Procedure/SurgeryUndergo HAI
Irinotecan
DrugGiven IV
Leucovorin
DrugGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Oxaliplatin
DrugGiven IV
Panitumumab
Biological/VaccineGiven IV
Single Photon Emission Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Overall survival (OS)
Patients still living will be censored at the date last known alive. OS will be evaluated using the Kaplan-Meier method, and arms will be compared via a stratified log rank test.
Progression free survival (PFS)
Patients still living without disease progression will be censored at the date of last disease assessment. Disease progression will be based on findings from surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months after randomization, defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be analyzed similarly to OS, but with and without stratification for sensitivity.
Hepatic PFS
Patients still living without hepatic disease progression will be censored at the date of last disease assessment. Hepatic disease progression will be based on findings from surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months after randomization, defined by RECIST 1.1.
Extrahepatic-PFS
Patients still living without extrahepatic disease progression will be censored at the date of last disease assessment. Extrahepatic disease progression will be based on findings from surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months after randomization, defined by RECIST 1.1.
Objective response rate
Will assess hepatic disease burden specifically. Defined as the proportion of patients achieving complete or partial response by RECIST 1.1. Response will be based on surveillance cross-sectional imaging of the chest/abdomen/pelvis every 3 months (+/- 2 weeks) from randomization. Arms will be compared via a Pearson chi-square test. All rates will be reported with exact binomial 95% confidence intervals.
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