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Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Treating Patients With Primary Liver Cancer That Cannot Be Removed By Surgery

2014-07-23 21:45:23 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine together with dexamethasone directly into the arteries around the tumor may kill more tumor cells.

PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works in treating patients with primary liver cancer that cannot be removed by surgery.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

dexamethasone, floxuridine, comparative genomic hybridization, cytogenetic analysis, conventional surgery

Location

Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10021

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:45:23-0400

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