Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan
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|ClinicalTrials.gov Identifier: NCT00613028|
Recruitment Status : Completed
First Posted : February 12, 2008
Results First Posted : February 4, 2013
Last Update Posted : July 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Gliosarcoma||Drug: Temo + Avastin Drug: VP-16 + Avastin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab Plus Either Temozolomide or Etoposide for (GBM) Patients Who Have Failed Bevacizumab Plus Irinotecan|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||January 2011|
Experimental: Temo + Avastin
Patients treated with bevacizumab + temozolomide
Drug: Temo + Avastin
Patients have progressed/had gr3/> toxicity related to etoposide, with no had progression/gr 3/> toxicity related to temozolomide, will only be considered for bevacizumab and temozolomide. Bevacizumab intravenously at dose 10mg/kg every other wk. For patients on bevacizumab and temozolomide, temozolomide administered on continuous dosing schedule at 50mg/m2/day.
Experimental: VP-16 + Avastin
Patients treated with bevacizumab and VP-16 (etoposide)
Drug: VP-16 + Avastin
Patients have progressed/had gr3/> toxicity related to temozolomide, but have not progressed/gr3/> toxicity related to etoposide,considered only for bevacizumab and etoposide. Bevacizumab intravenously at dose 10mg/kg every other wk. Patients on bevacizumab and etoposide, etoposide once daily at 50mg/m2/day first 21 days of each 28-day cycle.
- The Primary Outcome Measure is 6 Month Progression-free Survival. [ Time Frame: 6 months ]Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.
- Radiographic Response [ Time Frame: 41 months ]Percentage of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.
- Median Progression-free Survival (PFS) [ Time Frame: 41 months ]Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
- Median Overall Survival (OS) [ Time Frame: 41 months ]Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
- Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities. [ Time Frame: 41 months ]Incidence of ≥Grade 3 treatment related, non-hematologic toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613028
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David A. Reardon, MD||Duke University Health System|