Phase 2
N=74
Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma
Glioblastoma · Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00525525 ↗Enrolled (actual)
74
Serious AEs
52.7%
Results posted
Nov 2014
Primary outcome: Primary: Overall Survival (OS) — 19.8 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Tarceva (Drug); Temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
19.8 | — |
| PRIMARY Unexpected Toxicities During First 2 Cycles of Study Drug |
— | — |
| SECONDARY Progression-free Survival |
13.5 | — |
Summary
This is a phase II study of Bevacizumab plus Temodar and Tarceva in patients with non-progressive glioblastoma or gliosarcoma. Patients must have stable disease immediately following a standard course of up-front radiotherapy and Temodar. All patients will receive Bevacizumab, Temodar and Tarceva. A total of 60 patients will be enrolled. Our hypothesis is that the combination of Bevacizumab plus Temodar and Tarceva will increase survival over that seen in historical controls who have newly diagnosed, non-progressive glioblastoma or gliosarcoma following radiotherapy plus Temodar and use Temodar alone.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically proven, non-progressive glioblastoma multiforme (GBM) or gliosarcoma (GS) with stable disease immediately following XRT + TMZ. All patients will receive Bevacizumab plus Tarceva and TMZ.
- Biopsy or resection must have been performed prior to RT + TMZ.
- No chemotherapy is allowed prior to starting RT + TMZ, including Gliadel Wafers.
- Patients will have started RT + TMZ prior to registration and study entry and are eligible as long as they do not have progressive disease and can start Bevacizumab + TMZ and Tarceva within 4 weeks after the completion of RT + TMZ. Patients MUST have been treated with at least 54 Gy radiotherapy (60 Gy recommended) and MUST have received Temodar concurrently with radiotherapy for eligibility for this study.
- Patients may or may not have measurable or evaluable disease on contrast MR imaging. A post-radiotherapy MRI scan must document stable disease.
- Patients must be > 18 years old and with a life expectancy > 12 weeks.
- Patients must have a Karnofsky performance status of ≥ 70.
- Patients must have adequate bone marrow function (WBC > 3,000/µl, ANC > 1,500/mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 mg/dl), adequate liver function (SGOT and bilirubin 150 and/or diastolic blood pressure > 100 mmHg) on antihypertensive medications.
- Patients must not have any prior history of hypertensive crisis or hypertensive encephalopathy.
- Patients must not have New York Heart Association Grade II or greater congestive heart failure (see Appendix E).
- Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT00525525). 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.