Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Liver Metastases
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Colon
Eligibility Criteria
Inclusion Criteria: Histologically confirmed colorectal adenocarcinoma metastatic to the liver No extrahepatic metastases Prior complete surgical resection of hepatic metastases (at least 1 lesion) within the past 21-56 days Negative surgical margins unless surrounding normal liver tissue was ablated during surgery Radiofrequency ablation may be used as adjunct to surgical resection but not as primary treatment No prior operative ultrasound during resection of hepatic metastases Prior complete surgical resection of carcinoma of colon or rectum (must appear completely resectable in case of synchronous lesions) Performance status - ECOG 0-1 Absolute neutrophil count at least 1,200/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis) Creatinine no greater than ULN Creatinine clearance greater than 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Adequate oral nutrition (at least 1,500 calories/day) Able to withstand major operative procedure No dehydration No severe anorexia No frequent nausea or vomiting No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis No concurrent immunotherapy No concurrent colony-stimulating factors during the first course of study therapy No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan One prior 5-FU-based regimen as neoadjuvant treatment for rectal cancer is allowed No prior hepatic artery infusion therapy with 5-FU or floxuridine No prior systemic chemotherapy for metastatic disease No other concurrent chemotherapy No concurrent radiotherapy See Disease Characteristics No prior or concurrent sorivudine or brivudine
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy)
Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity. After completion of the fourth course, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity.