Study on Using Hepatic Arterial Infusion with Floxuridine and Dexamethasone Combined with Chemotherapy for Colorectal Cancer Spread to the Liver

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal adenocarcinoma metastatic to the liver

  • Previously treated or untreated disease
  • No clinical or radiographic evidence of extrahepatic disease

• Primary tumor may be present at study registration provided it is not obstructing the intestinal lumen or is significantly bleeding

  • If present, the primary tumor will be resected at the time of pump placement

• Must have inoperable liver metastases confirmed by 2-3 hepatobiliary surgeons and the assigned radiologist

  • Liver metastases < 70% of the liver parenchyma

  • Inoperable liver metastases is defined by one of the following:

    • More than 6 metastases in a single lobe with one lesion ≥ 5 cm
    • At least 6 metastases distributed diffusely in both lobes of the liver
    • When a margin-negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava
    • Requires a resection that leaves < 2 hepatic segments (not including the caudate lobe) behind with adequate arterial or portal inflow, venous outflow, and biliary drainage

• No ascites or hepatic encephalopathy

• No history of primary CNS tumors

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• WBC ≥ 3,000/mm^3

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• INR < 1.5

• Hemoglobin ≥ 9 g/dL

• Creatinine ≤ 1.5 mg/dL

• Total bilirubin ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Physically able to tolerate major partial hepatectomy

• No active infection

• No concurrent active malignancies, except potentially resectable primary colorectal tumor

• No bleeding diathesis or coagulopathy

• No history of serious systemic disease, including any of the following:

  • Myocardial infarction within the past 6 months

  • Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)

  • Unstable angina

  • New York Heart Association class II-IV congestive heart failure

  • Unstable symptomatic arrhythmia requiring medication

    • Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed

  • Peripheral vascular disease ≥ grade 2

• No serious or nonhealing active wound, ulcer, or bone fracture

• No history of seizures not well controlled with standard medical therapy

• No stroke or transient ischemic attack within the past 6 months

• No concurrent obstruction of the gastrointestinal or genitourinary tract

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior radiotherapy to the pelvis
• Prior chemotherapy allowed
• No prior radiotherapy, hepatic thermal ablation, or resection (other than biopsy) to the liver
• No prior floxuridine
• No prior hepatic arterial infusion
• No concurrent chronic aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
• No other concurrent investigational agents