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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00310102 |
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.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: dexamethasone Drug: floxuridine Procedure: comparative genomic hybridization Procedure: conventional surgery Procedure: cytogenetic analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy |
Estimated Enrollment: | 35 |
Study Start Date: | September 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma (i.e., peripheral cholangiocarcinoma, cholangiolar carcinoma, or cholangiocellular carcinoma)
Disease must be confined to the liver
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Perry Shen, MD | Wake Forest University |
Study ID Numbers: | CDR0000466324, CCCWFU-55104, CCCWFU-BG04-320, MSKCC-02120A |
Study First Received: | March 29, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00310102 |
Health Authority: | United States: Federal Government |
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary cholangiocellular carcinoma |
Dexamethasone Cholangiocarcinoma Liver Diseases Digestive System Neoplasms Floxuridine Carcinoma, Hepatocellular Liver neoplasms |
Recurrence Carcinoma Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Dexamethasone acetate Hepatocellular carcinoma |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |