Liver Metastases Clinical Trial
Official title:
Phase I Study of Drug-Eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-Only or Liver-Predominant Disease
This phase I trial studies the side effects and best dose of irinotecan-eluting beads in treating patients with colon or rectal cancer that has spread to the liver and does not respond to treatment with standard therapy. Irinotecan-eluting beads are tiny beads that have been loaded with irinotecan hydrochloride, a chemotherapy drug. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. This treatment delivers the chemotherapy directly to the tumor area inside the liver instead of to the whole body as with systemic delivery of the drug. Irinotecan-eluting beads may work better that standard chemotherapy in treating patients with colon or rectal cancer that has spread to the liver.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of drug eluting irinotecan (irinotecan
hydrochloride) beads (irinotecan-eluting beads), delivered intrahepatically for the treatment
of liver only or liver-predominantly colorectal metastatic disease.
SECONDARY OBJECTIVES:
I. To determine the response rate of colorectal liver metastases treated with drug-eluting
irinotecan beads in refractory metastatic colorectal patients with liver only or liver
predominant disease.
II. To determine the time to progression of colorectal liver metastases treated with
drug-eluting irinotecan beads in refractory metastatic colorectal patients with liver only or
liver predominant disease.
III. To determine the overall survival of patients treated with drug-eluting irinotecan beads
for liver only or liver predominant metastatic disease from colorectal cancer.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for a
total of 2 treatments in the absence of disease progression or unacceptable toxicity.
Patients with bi-lobular disease and no evidence of progression in the treated lobe may
repeat treatment at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 30 days and then every 3
months for 2 years.
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