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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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Medical and Biotech [MESH] Definitions

A method for analyzing and mapping differences in the copy number of specific genes or other large sequences between two sets of chromosomal DNA. It is used to look for large sequence changes such as deletions, duplications, or amplifications within the genomic DNA of an individual (with a tumor for example) or family members or population or between species.

MOLECULAR BIOLOGY techniques used in the diagnosis of disease. Included are such techniques as IN SITU HYBRIDIZATION of chromosomes for CYTOGENETIC ANALYSIS; OLIGONUCLEOTIDE ARRAY SEQUENCE ANALYSIS of gene expression patterns in disease states; identification of pathogenic organisms by analysis of species specific DNA sequences; and detection of mutations with POLYMERASE CHAIN REACTION.

Synthetic or natural oligonucleotides used in hybridization studies in order to identify and study specific nucleic acid fragments, e.g., DNA segments near or within a specific gene locus or gene. The probe hybridizes with a specific mRNA, if present. Conventional techniques used for testing for the hybridization product include dot blot assays, Southern blot assays, and DNA:RNA hybrid-specific antibody tests. Conventional labels for the probe include the radioisotope labels 32P and 125I and the chemical label biotin.

Species- or subspecies-specific DNA (including COMPLEMENTARY DNA; conserved genes, whole chromosomes, or whole genomes) used in hybridization studies in order to identify microorganisms, to measure DNA-DNA homologies, to group subspecies, etc. The DNA probe hybridizes with a specific mRNA, if present. Conventional techniques used for testing for the hybridization product include dot blot assays, Southern blot assays, and DNA:RNA hybrid-specific antibody tests. Conventional labels for the DNA probe include the radioisotope labels 32P and 125I and the chemical label biotin. The use of DNA probes provides a specific, sensitive, rapid, and inexpensive replacement for cell culture techniques for diagnosing infections.

An antineoplastic antimetabolite that is metabolized to fluorouracil when administered by rapid injection; when administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. It has been used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract.

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