Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas
- Sponsor
- Rigshospitalet, Denmark
- Study ID
- NCT00463073
- Phase
- PHASE2
- Status
- Completed
Conditions
- Malignant Gliomas
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cetuximab — DRUG
- Bevacizumab — DRUG
- Irinotecan — DRUG
Study Details
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.
Key Dates
- Start date
- Aug 31, 2006
- Status verified
- Dec 2008
- Primary completion
- Dec 31, 2008
- Completion
- Dec 31, 2008
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP