Phase 2
N=182
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
Glioblastoma Multiforme
Bottom Line
View on ClinicalTrials.gov: NCT00967330 ↗Enrolled (actual)
182
Serious AEs
75.9%
Results posted
Nov 2015
Primary outcome: Primary: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months — 79.31; 42.59 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab [Avastin] (Drug); irinotecan (Drug); temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months |
79.31; 42.59 | <0.0001 sig |
| SECONDARY Progression-Free Survival (PFS) |
9.74; 5.99 | 0.0012 sig |
| SECONDARY Overall Survival (OS) |
16.64; 17.30 | 0.8283 |
| SECONDARY Percentage of Participants Who Discontinued |
0; 1.9; 0.9; 0; 0.9; 0 | — |
| SECONDARY Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR) |
11; 2; 11; 1; 3; 1 | 0.34745 |
| SECONDARY Percentage of Participants With Response on FLAIR Imaging |
72.4; 72.2; 17.2; 16.7; 16.4; 20.4 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30) |
-8.3513; -6.2511; -0.7635; -2.2339; 2.2774; 2.2547 | 0.4975 |
| SECONDARY Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30) |
-5.2779; -8.5478; -2.0869; -3.202; 5.4416; 6.5429 | 0.3613 |
| SECONDARY Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30) |
-0.01771; -0.2110; -0.00264; -0.03219; -0.05763; 0.08530 | 0.0817 |
| SECONDARY Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30) |
-3.3399; -5.4909 | 0.2078 |
| SECONDARY Percentage of Participants Who Received Corticosteroid for Glioblastoma |
80.0; 78.7 | — |
| SECONDARY Time to Treatment Failure |
NA; NA | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00967330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.