A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically* or cytologically confirmed colorectal adenocarcinoma

- No other cellular type (e.g., sarcoma, lymphoma, or carcinoid) NOTE: *If the
primary colorectal tumor and the hepatic lesions have been identified at the
same time and it is not possible to biopsy the colorectal lesion, the patient
will be eligible without histologic confirmation of the colorectal primary
cancer as long as other radiographic studies or scans document the
characteristics of a colorectal cancer

- Synchronous or metachronous metastatic disease confined to the liver

- No more than 6 hepatic metastatic lesions that can potentially be resected or
ablated

- For patients presenting with synchronous lesion(s) in the colon and/or rectum,
the primary tumors must, in the opinion of the investigator, appear to be
completely resectable

- Must be able to undergo surgery and/or ablation within 28 days following
randomization

- No evidence of extrahepatic metastases

- No prior colorectal metastases

- No recurrent colorectal cancer concurrent with hepatic metastases

PATIENT CHARACTERISTICS:

- Life expectancy ≥ 5 years, excluding their colorectal cancer

- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

- No other malignancy within the past 5 years except carcinoma in situ of the cervix,
melanoma in situ, basal cell or squamous cell skin cancer, or carcinoma of the colon
or rectum

- Absolute granulocyte count ≥ 1,200/mm^3

- Platelet count ≥ 100,000/mm^3

- PT/international normalized ratio (INR) ≤ 1.5 unless patient is on therapeutic doses
of anticoagulant medication

- Total bilirubin ≤ upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 ULN

- aspartate aminotransferase (AST) ≤ 2.5 times ULN

- Calculated creatinine clearance > 50 mL/min

- Not pregnant or lactating

- Negative pregnancy test

- Patients with child bearing potential must agree to use adequate contraception

- Able to swallow oral medication

- No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis)

- No grade 3 or 4 anorexia or nausea

- No vomiting ≥ grade 2

- No clinically significant peripheral neuropathy defined as ≥ grade 2 neurosensory or
neuromotor toxicity

- No psychiatric or addictive disorders or other condition that, in the opinion of the
investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

- Prior adjuvant fluorouracil alone or in combination with levamisole, leucovorin
calcium, irinotecan hydrochloride, or oxaliplatin allowed if these regimens were
completed > 6 months ago

- No prior resection/ablation, hepatic arterial infusion therapy, or any systemic
chemotherapy for metastatic disease

- Prior excisional biopsy allowed

- No prior radiotherapy to the liver

- No concurrent bevacizumab in patients who have had pump/catheter placement receiving
hepatic arterial infusion of floxuridine

- Patients who meet specific situations outlined in the protocol and who have not
had pump placement may receive bevacizumab at the physician's discretion

- No concurrent halogenated antiviral agents such as sorivudine or brivudine in
patients receiving fluorouracil, floxuridine, or capecitabine

- No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) as primary
prophylaxis for neutropenia

- Following neutropenic events, these drugs may be used at the physician's
discretion during subsequent cycles

- No other concurrent cancer therapy

- No other concurrent investigational agents