Phase 2
N=59
Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
Glioblastoma · Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00612430 ↗Enrolled (actual)
59
Serious AEs
8.5%
Results posted
Jul 2013
Primary outcome: Primary: 6 Month Progression-Free Survival (PFS) — 41; 44 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab and Etoposide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Month Progression-Free Survival (PFS) |
41; 44 | — |
| SECONDARY Objective Response Rate |
24; 23 | — |
| SECONDARY Safety of Study Treatment Regimen |
9; 13 | — |
| SECONDARY Median Progression-Free Survival |
24; 18 | — |
| SECONDARY Median Overall Survival (OS) |
63.1; 46.4 | — |
Summary
Primary Objective to estimate 6-month progression free survival probability of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.
Secondary Objectives To evaluate safety & tolerability of Etoposide + Bevacizumab among patients with recurrent malignant glioma (RMG).
To evaluate radiographic response, progression free survival & overall survival of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.
Eligibility Criteria
Inclusion Criteria
- Pts have confirmed diagnosis of recurrent/progressive WHO gr III & IV MG
- Age >18 rs
- Interval of >4 wks since prior surgery
- Interval of >4 wks since prior XRT/chemo, unless there is unequivocal evidence of progressive disease & pts have recovered from all anticipated toxicity of most recent therapy;
- Karnofsky performance status score >60
- Hematocrit >29 percent, ANC >1,500 cells/microliter, platelets >100,000 cells/microliter
- Serum creatinine 3 prior recurrences
- Pregnancy/breast feeding
- Co-medication w immuno-suppressive agents other than corticosteroids including but not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil
- Evidence of CNS hemorrhage on baseline MRI on CT scan
- Pts who require therapeutic anti-coagulation
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state
- Pts w another primary malignancy that has required treatment <past year
Data sourced from ClinicalTrials.gov (NCT00612430). 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.