CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Bevacizumab +3 moredrug
Likely dose
Bevacizumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01004874
NCT01004874Phase 2Completed
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Avastin in Combination With Radiation and Temozolomide Followed by Avastin, Temozolomide, and Topotecan for Glioblastoma Multiformes and Gliosarcomas

Duke University·interventional·Posted Oct 30, 2009·Updated Apr 13, 2022

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Temozolomide, and 2 other interventions for Malignant Glioma and 2 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This is a phase II study of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and topotecan in grade IV malignant glioma patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Glioma, Glioblastoma, Gliosarcoma
CountriesUnited States
CollaboratorsGenentech, Inc., GlaxoSmithKline

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2009
Enrollment StartDec 30, 2009
Primary CompletionJul 1, 2012
Study CompletionNov 2, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.7 years ago

Interventions

Bevacizumabdrug

Bevacizumab (Avastin) at 10 mg/kg every other week during standard radiation therapy (XRT). Following XRT, bevacizumab will remain at 10 mg/kg every other week.

Temozolomidedrug

Daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation therapy (XRT). Following XRT, temozolomide will be dosed at 150 mg/m2 daily the first 5 days of each 28-day cycle.

Radiation Therapy (XRT)radiation

Standard radiation therapy for approximately 6.5 weeks

Topotecandrug

Following standard radiation therapy, patients will receive topotecan on days 2 through 6 of each 28-day cycle at a dose of 1.5 mg/m2 for patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs) and 2.0 mg/m2 for patients taking EIAEDs.