Spots Global Cancer Trial Database for Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

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Trial Identification

Brief Title: Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Official Title: Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization

Study ID: NCT00293397

Conditions

Liver Cancer

Interventions

Drug-eluting beads loaded with doxorubicin hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: * Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma. OUTLINE: This is a pilot study. Patients undergo catheterization of the hepatic artery followed by chemoembolization comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the target hepatic artery. Patients may receive up to 3 chemoembolization treatments. After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months during year 2. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.