NCT01631539

Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC

Chemoembolisation With Irinotecan Loaded DC Bead (DEBIRI) in Combination With Cetuximab and 5FU/LV in the First Line Treatment of Patients With KRAS Wildtype Metastatic Colorectal Cancer (mCRC)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.

Detailed description

20 patients will be included. The duration of the trial will be approximately 24 months. Every 8 weeks there will be a tumour lesion assessment.

Conditions

• Liver Metastases
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	DC Bead™	chemoembolization with DC Bead™ loaded with Irinotecan
DRUG	Cetuximab	400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
DRUG	5 FU	every 2 weeks IV
DRUG	Irinotecan	every 4 weeks chemoembolization

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-06-29
• Last updated: 2014-12-04