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A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

Phase 2
18 Years
Not Enrolling
Liver Cancer

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Trial Information

A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy



- Assess the efficacy of continuous hepatic arterial infusion comprising floxuridine and
dexamethasone in patients with unresectable primary hepatocellular carcinoma or
intrahepatic cholangiocarcinoma.

- Assess the tolerability of this therapy, stratified by degree of underlying hepatic
parenchymal disease, as determined on liver biopsy, in these patients.


- Evaluate changes in tumor perfusion during treatment by dynamic MRI in patients treated
with this regimen.

- Correlate changes in tumor perfusion with radiographic tumor response in patients
treated with this regimen.

- Investigate molecular genetic changes associated with these tumors using comparative
genomic hybridization and cDNA array from tumor and liver biopsy specimens obtained at
the time of surgery.

OUTLINE: This is a multicenter study.

Patients undergo surgery comprising abdominal exploration, liver biopsy, and hepatic artery
pump placement. Patients then receive hepatic arterial infusion comprising floxuridine and
dexamethasone continuously on days 1-14. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.

Tissue biopsies obtained at the time of pump placement are examined for molecular genetic
abnormalities by cDNA array and comparative genomic hybridization studies.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma
(i.e., peripheral cholangiocarcinoma, cholangiolar carcinoma, or cholangiocellular

- Patients suspected of having mixed tumors allowed

- Patients with a liver mass that is radiographically consistent with
hepatocellular carcinoma and a serum alpha fetoprotein (AFP) > 500 ng/dL do not
require biopsy confirmation

- Disease must be confined to the liver

- Less than 70% liver involvement by cancer

- Radiographically measurable disease

- Unresectable disease

- No clinical or radiographic evidence of extrahepatic disease

- Patients who have failed prior ablative therapy allowed

- No clinical ascites


- Karnofsky performance status 60-100%

- Albumin > 2.5 g/dL

- WBC > 3,500/mm³

- Platelet count > 100,000/mm³

- Bilirubin < 1.8 mg/dL

- INR < 1.5 in patients not on warfarin therapy

- Patients must be considered candidates for general anesthesia and hepatic artery pump

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Patients with chronic hepatitis and/or cirrhosis allowed if Child-Pugh class A

- No sclerosing cholangitis

- No Gilbert's disease

- No hepatic encephalopathy

- No radiographic evidence of esophageal varices or history of variceal hemorrhage

- No occlusion of the main portal vein or the right and left portal branches

- No active infection

- No other malignancy except localized basal cell or squamous cell skin cancer


- See Disease Characteristics

- No prior floxuridine

- No prior external beam radiation therapy to the liver

- Prior exploratory surgery resulting in diagnosis of unresectable disease allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity in terms of response rate

Safety Issue:


Principal Investigator

Perry Shen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary cholangiocellular carcinoma
  • Liver Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021