Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer

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 at MSKCC.

• Patient's liver metastases must be deemed unresectable and comprise <70% of the liver parenchyma.
• A patient may have had prior chemotherapy or be previously untreated.
• Patient may not have received prior treatment with FUDR or >2 doses of Oxaliplatin.
• KPS > or = to 60%.
• WBC > or = to 3,000 cells/mm3 and platelet count > or = to 100,000 cells/mm3 within 14 days of registration.
• Creatinine < or = to 1.5 mg/dl within 14 days of registration.
• Total serum bilirubin < or = 2.0 mg/dl within 14 days of registration.

Exclusion criteria

• No active concurrent malignancies: except a patient's potentially resectable colorectal primary.
• Patient must not have obstruction of GI or GU tract.
• Patient must not have current, symptomatic peripheral sensory neuropathy.
• No prior radiation to liver.
• No active infection, ascites, or hepatic encephalopathy.
• Age ≥ 18 years.
• Female patients cannot be pregnant or lactating.
• Signed informed consent.