A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma

Roche

Status and phase: Completed; Phase 2

Conditions: Glioblastoma Multiforme

Treatments: Drug: irinotecan; Drug: temozolomide; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00967330

ML21965

2009-010390-21

Details and patient eligibility

About

This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Enrollment: 182 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-70 years of age;
• glioblastoma, confirmed histologically;
• no previous chemotherapy or radiotherapy for glioblastoma;
• non-methylated MGMT promoter in the tumor.

Exclusion criteria

• prior systemic treatment for glioblastoma multiforme;
• prior treatment with Avastin;
• significant cardiovascular disease;
• other active malignant disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: irinotecan

2

Active Comparator group

Treatment:

Drug: temozolomide