NCT00932438

Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.

Detailed description

This is a multicentre, open labeled, prospective, randomized, controlled phase I/II study designed to assess the clinical performance of chemoembolization with Low Compression Bead (LC Bead), loaded with irinotecan in combination with intravenous chemotherapy and bevacizumab versus intravenous chemotherapy in combination with bevacizumab in the treatment of unresectable liver metastases in patients with colorectal cancer.

Conditions

• Colon Cancer With Metastases to the Liver

Interventions

Type	Name	Description
DEVICE	LC beads loaded with Irinotecan	Chemoembolization using LC beads loaded with 100mg Irinotecan
DRUG	Oxaliplatin	Oxaliplatin 85 mg/sqm, IV infusion every two weeks
DRUG	Leucovorin	Leucovorin 200 mg/sqm, IV infusion every two weeks
DRUG	5-Fluorouracil	5-Fluorouracil 2400 mg/sqm, IV infusion every 2 week
DRUG	Bevacizumab	Bevacizumab 5 mg/kg given at the discretion of the treating physician

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-07-03
• Last updated: 2021-06-11
• Results posted: 2021-05-07

Locations

10 sites across 2 countries: United States, Argentina