NCT00463073

Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas

A Phase II Trial With Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas and Progression After Radiation Therapy and Temozolamide

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas. In addition, 40-50 % of GBM have EGFR amplification/mutation making the EGFR an additional target. By combing cetuximab, with irinotecan and bevacizumab, one would expect further response, than irinotecan and bevacizumab alone. In addition, recurrent gliomas have an extremely poor prognosis, so innovative therapies are needed.

Conditions

• Malignant Gliomas

Interventions

Type	Name	Description
DRUG	Cetuximab
DRUG	Bevacizumab
DRUG	Irinotecan

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-04-20
• Last updated: 2008-12-11

Locations

3 sites across 1 country: Denmark