drugset / Trial / NCT00463203

Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy

NCT00463203 ↗

Phase 2 Completed 54 enrolled Rigshospitalet, Denmark
Non-randomizedSingle-groupOpen-labelTreatment

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. Recent data form a small study of 32 patients from Duke University have achieved a response rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but this regimen may also have activity in more rare primary malignant brain tumors. The investigators therefore plan to include other primary malignant brain tumors in this study, and the clinical activity will be correlated with biomarkers and PET results of metabolic activity and blood flow. This may result in information that can be used to individualize therapy in the future.

Timeline

Start
2007-03
Primary completion
2011-03
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg —
Subject Irinotecan Small molecule 125 mg/m2 —
Subject Irinotecan Small molecule 340 mg/m2 —

Indications