Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
Subject 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. Potentially completely resectable hepatic metastases without current evidence of other metastatic disease. Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to registration. (MRI of abdomen may be substituted for CT of abdomen.) Lab values within 14 days prior to registration: WBC ≥ 3.0 K/ul ANC >1.5 K/ul Platelets ≥ 100 K/ul Total bilirubin ≤ 1.5 mg/dl. Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study. KPS ≥ 60% Signed informed consent. Subject Exclusion Criteria: Prior radiation to the liver. (Prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.) Active infection, ascites, hepatic encephalopathy Prior oxaliplatin or cisplatin or HAI FUDR Female patients who are pregnant or lactating
Sites / Locations
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy
This is a Phase I study with the primary objective of defining the maximum tolerated dose of hepatic arterial floxuridine (FUDR) and dexamethasone (Dex) given via an implanted pump in combination with intravenous oxaliplatin plus systemic fluorouracil (5FU)/leucovorin (LV) in the adjuvant setting after resection of hepatic metastases from colorectal cancer. A total of eleven dose levels will be considered.