Clinical Trial: Irinotecan-Eluting Beads in Treating Patients With Refractory Metastatic Colon or Rectal Cancer That Has Spread to the Liver
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase I Study of Drug-Eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-Only or Liver-Predominant Disease
Brief 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 Summary:
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.
Sponsor: Fox Chase Cancer Center
Current Primary Outcome: Maximum tolerated dose of irinotecan-eluting beads, determined by dose limiting toxicities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 3 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Response rate, classified using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 [ Time Frame: 8 weeks following administration of irinotecan-eluting beads ]
- Duration of overall response [ Time Frame: From the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years ]
- Time to progression [ Time Frame: From start of treatment to progression in the treated lobe, assessed up to 2 years ]
Original Secondary Outcome: Same as current
Information By: Fox Chase Cancer Center
Dates:
Date Received: April 8, 2014
Date Started: January 2016
Date Completion: April 2019
Last Updated: April 12, 2017
Last Verified: April 2017
