drugset / Trial / NCT01060423
TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | — |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |