Bevacizumab and Irinotecan or Bevacizumab and Temozolomide With Concomitant Radiotherapy for Primary Glioblastoma Multiforme (GBM)

Phase 2

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Bevacizumab and Temozolomide and radiotherapy; Drug: bevacizumab and Irinotecan and radiotherapy

• Registration Number: NCT00817284
• Lead Sponsor: Ulrik Lassen

Brief Summary

Significant activity (radiographic response rates of approximately 60%) has recently been demonstrated in phase II studies in patients with relapsed GBM from the combined use of Irinotecan (CPT-11) and bevacizumab. The 6-month progression-free survival rate is 30% and median survival duration is 9 months. The current first line therapy of GBM patients following initial surgical resection/debulking is the concomitant use of cerebral radiotherapy and the orally available alkylating agent temozolomide, followed by temozolomide for 6 months post-radiotherapy.

Considering the significant activity of the combination of Bevacizumab + irinotecan in patients with recurrent GBM, and considering the activity of temozolomide in GBM, it is proposed that the combination of Bevacizumab + Temozolomide may also be an active regimen. Bevacizumab + Temozolomide display non-overlapping toxicity clinically and thus their combined use without significant dose-reductions seems rational.

The toxicity from the combined use of the two drugs prior to radiotherapy, as well as the toxicity when administered together with radiotherapy, is evaluated.

This study will try to identity whether Bevacizumab and Irinitecan or Bevacizumab and Temozolomide should be the experimental arm in future phase III comparison with standard care with concomitant Temozolomide and radiotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-29
• Last Update Posted: 2011-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	Bevacizumab and Temozolomide and radiotherapy	Bevacizumab and Temozolomide and concomitant radiotherapy
arm I	bevacizumab and Irinotecan and radiotherapy	Bevacizumab + Irinotecan and concomitant radiotherapy

Primary Outcome Measures

Name	Time	Method
Objective response rate according to McDonald criteria	6 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	6 months

Trial Locations

Locations (3)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense Hospital; 🇩🇰 Odense, Denmark

Århus Hospital; 🇩🇰 Århus, Denmark