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

Inclusion Criteria

• •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