The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy.
History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Patients with resectable or ablatable lung metastasis are eligible.
Physically able to tolerate major partial hepatectomy.
The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement.
Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen).
Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration).
Patient may not have received prior treatment with FUDR.
Active infection, ascites, hepatic encephalopathy.
Active concurrent malignancies, except a patient's potentially resectable colorectal primary.
Single group
Floxuridine (FUDR)
DrugFloxuridine will be administered at a recommended dose of 0.12 mg/kg/day and adjusted as per participants weight and lab results.
Proportion of participants that undergo liver resection following treatment with FUDR
To assess the rate of conversion to liver resection in patients with initially inoperable hepatic-metastases due to colorectal cancer after treatment with hepatic artery infusion pump therapy and standard of care systemic therapy.
Time to disease progression in all participants
To evaluate time to progression (TTP).
Time prior to disease progression in all participants
To evaluate disease-free survival (DFS).
Time to intrahepatic disease progression in all participants
To evaluate time to disease progression in liver.
Time to death in all participants
Overall survival
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