Phase 2
Completed N=23
Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan
Glioblastoma · Gliosarcoma
Source: ClinicalTrials.gov NCT00613028 ↗
Enrolled (actual)
23
Serious AEs
26.1%
Results posted
Feb 2013
Primary outcomePrimary: The Primary Outcome Measure is 6 Month Progression-free Survival. — 0; 7.7 percentage of participants
Summary
Primary objective To estimate 6-month progression free survival probability of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan Secondary Objectives To evaluate safety & tolerability of bev + either daily temozolomide/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To evaluate radiographic response, progression free survival & overall survival of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure is 6 Month Progression-free Survival. |
0; 7.7 | — |
| SECONDARY Radiographic Response |
0; 0 | — |
| SECONDARY Median Progression-free Survival (PFS) |
4.1; 8.1 | — |
| SECONDARY Median Overall Survival (OS) |
12.6; 19 | — |
| SECONDARY Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities. |
1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Pts have confirmed diagnosis of GBM & radiographic evidence of recurrence following prior therapy w bev + irinotecan
- Age >18 yrs
- Interval of >4 wks between prior surgical resection/1 week from stereotactic biopsy
- Interval of >12 wks from end of prior external beam radiation therapy (XRT) unless there is new area of enhancement consistent w recurrent tumor outside of XRT field,/there are progressive changes on MRI on >2 consecutive MRI scans >4wks apart, /there is biopsy-proven tumor progression
- Interval of >4 wks from prior chemo / investigational agent unless pt has recovered from all anticipated toxicities associated w that therapy.
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Hematocrit >29percent, absolute neutrophil count (ANC)>1,000 cells/ml l, platelets > 100,000 cells/ml l
- Serum creatinine 1.0 at screening /
- Urine dipstick for proteinuria ≥ 2+
- Known hypersensitivity to any component of bevacizumab
- Pregnant or lactating. Use of effective means of contraception in subjects of child-bearing potential
Data sourced from ClinicalTrials.gov (NCT00613028). 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. Informational only — not medical advice.