drugset / Trial / NCT01060423

TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer

NCT01060423 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer. Secondary objectives are safety and tolerability of hepatic chemoembolization and the question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and emesis.

Timeline

Start
2010-02
Primary completion
2012-12
Completion
2015-05

Outcome

Outcome not reported

Stopped: “Terminated due to poor subject enrolment”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Irinotecan Small molecule 180 mg/m2 —
Background Cetuximab Monoclonal antibody 250 mg/m2 Intravenous

Indications