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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Antitumor activity in terms of response rate
Perry Shen, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|