Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery

Criteria the registry did not label

• DISEASE CHARACTERISTICS:
• Histologically confirmed hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC)
  • Peripheral, cholangiolar, or cholangiocellular types
  • Mixed HCC/ICC disease allowed
  • Unresectable disease
  • Less than 70% liver involvement
• Radiographically bidimensionally measurable disease, defined as lesion ≥ 2 cm in the greatest diameter
• May have failed prior systemic chemotherapy or ablative therapy
• No radiographic evidence of esophageal varices
• No history of variceal hemorrhage
• No occlusion of the main portal vein or the right and left portal branches
• No clinical ascites
• Patients ineligible for first-line MSKCC protocols for HCC are eligible for this study provided there is no clinical or radiographic evidence of extrahepatic disease
• No metastatic disease, including CNS metastases
  • PATIENT CHARACTERISTICS:
• Life expectancy ≥ 12 weeks
• Karnofsky performance status 60-100%
• Considered a candidate for general anesthesia and hepatic artery pump placement
• Platelet count \> 100,000/mm³
• Albumin \> 2.5 g/dL
• Bilirubin \< 1.8 mg/dL
• WBC \> 3,500/mm³
• PTT \< 1.5 times upper limit of normal
• INR \< 1.5 OR in-range INR (usually 2.0-3.0) for patients on a stable dose of therapeutic warfarin
• Urine protein \< 1+ by dipstick or urine analysis OR urine protein:creatinine ratio \< 1.0
  • If proteinuria ≥ 2+ at baseline, patient must have \< 1 g protein/24-hour collection
• No concurrent disease or illness that would preclude study participation, including any of the following:
  • Hepatic encephalopathy
  • Sclerosing cholangitis
  • Gilbert's disease
  • Active infection
• No known CNS disease
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab
• No psychiatric illness or social situation that would preclude study compliance
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No serious or nonhealing active wound, ulcer, or bone fracture
• No bleeding diathesis or coagulopathy
• No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 100 mm Hg on antihypertensive medications
  • New York Heart Association class II-IV congestive heart failure
  • Vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Myocardial infarction within the past 6 months
  • Symptomatic peripheral vascular disease
  • Unstable angina within the past 6 months
  • History of hypertensive crisis
  • Transient ischemic attack
  • Stroke
• No other concurrent malignancy except localized basal cell or squamous cell skin cancer
• Chronic hepatitis and/or cirrhosis allowed provided it is Child-Pugh class A disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• More than 4 weeks since prior and no other concurrent experimental therapy except on a Genentech-sponsored bevacizumab cancer study
• More than 4 weeks since prior major surgical procedure or open biopsy
• More than 1 week since prior minor surgical procedure (e.g., core biopsy), excluding placement of a vascular access device
• No prior external-beam radiation therapy to the liver
• No prior floxuridine
• No chronic daily treatment with nonsteroidal anti-inflammatory medications known to inhibit platelet function
• No chronic daily treatment with aspirin (\> 325 mg/day)
• No concurrent or recent use of a thrombolytic agent
• No concurrent major surgery