A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy
Condition: Hepatic Cancer
MeSH terms: Liver Neoplasms
Intervention: FLOXURIDINE
Intervention description: [0.16* mg/kg/day X 30 ml] / pump flow rate
* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles.
Intervention MeSH terms: Floxuridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FUDR; FLOXORUIDINE; DEXAMETHASONE; Hepatic; Cancer; 02-120

Summary:

      This phase II study aims to evaluate regional chemotherapy in patients with unresectable
      primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and
      peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary
      Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR.
      The protocol includes radiological and biological correlative studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a liver mass that is radiographically consistent with HCC and a serum
             alpha fetoprotein (AFP) > 500 ng/dl do not require biopsy confirmation of the
             diagnosis.

          -  Patients with HCC or ICC undergoing exploration for a possible curative resection but
             found to have unresectable disease confined to the liver will be eligible, provided
             that no intraoperative findings would exclude them and prior informed consent has been
             obtained (see below).

          -  There must be <70% liver involvement by cancer, and the disease must be considered
             unresectable.

          -  Patients who have failed ablative therapy will be eligible.

          -  Patients must have a KPS > 60% and be considered candidates for general anesthesia and
             hepatic artery pump placement.

          -  Patients with chronic hepatitis and/or cirrhosis are eligible

          -  Serum albumin must be >2.5 g/dl and total serum bilirubin must be <1.8 mg/dl based on
             preoperative laboratory values within 14 days of registration.

          -  WBC must be >3500 cells/mm3 and platelet count must be >100,000/mm3 based on
             preoperative laboratory values within 14 days of registration.

          -  The international normalized ratio (INR) must be less than 1.5 in patients not on
             coumadin therapy, based on preoperative laboratory values within 14 days of
             registration.

          -  Age >_ 18 years.

          -  Female patients cannot be pregnant or lactating.

          -  Patients must be able to understand and sign informed consent.

        Exclusion Criteria:

          -  Patients who have received prior treatment with FUDR

          -  Patients who have had prior external beam radiation therapy to the liver.

          -  Patients who have a diagnosis of sclerosing cholangitis.

          -  Patients who have a diagnosis of Gilbert's disease.

          -  Patients who have clinical ascites

          -  Patients with hepatic encephalopathy

          -  Patients who have radiographic evidence of esophageal varices or history of variceal
             hemorrhage.

          -  Patients with occlusion of the main portal vein nor of the right and left portal
             branches Patients that have concurrent malignancies (except localized basal cell or
             squamous cell skin cancers). Patient with active infection. Female patients who are
             pregnant or lactating.