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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Doxorubicin eluting beads
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Safety
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Time frame: 1 month
Safety
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Time frame: 6 months
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.
Time frame: 1 month
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Time frame: 1 month
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
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Time frame: 6 months
Efficacy - Overall Survival
Presented are the counts of patients that have survived up to 1 year.
Time frame: 1 Year
Efficacy - Overall Survival
Presented are the counts of patients that have survived up to 2 years.
Time frame: 2 Years