NCT02110953

Irinotecan-Eluting Beads in Treating Patients With Refractory Metastatic Colon or Rectal Cancer That Has Spread to the Liver

Phase I Study of Drug-Eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-Only or Liver-Predominant Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Metastases
• Mucinous Adenocarcinoma of the Colon
• Mucinous Adenocarcinoma of the Rectum
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Signet Ring Adenocarcinoma of the Colon
• Signet Ring Adenocarcinoma of the Rectum
• Stage IVA Colon Cancer
• Stage IVA Rectal Cancer
• Stage IVB Colon Cancer
• Stage IVB Rectal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	irinotecan-eluting beads	Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization
PROCEDURE	hepatic artery embolization	Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization

Timeline

• Start date: 2016-01-29
• Primary completion: 2017-04-04
• Completion: 2017-08-16
• First posted: 2014-04-10
• Last updated: 2018-02-26

Locations

1 site across 1 country: United States