A Phase II Study of Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation
- To determine the overall survival of patients with newly diagnosed glioblastoma
multiforme (GBM) with unmethylated MGMT promoter treated with bevacizumab and erlotinib
hydrochloride after radiotherapy and temozolomide.
- To determine the 12- and 24-month progression-free survival (PFS) of patients with
newly diagnosed GBM with unmethylated MGMT promoter treated with this regimen.
- To assess radiographic response rates.
- To perform correlative tissue assays.
- To collect safety data on the combination of bevacizumab and erlotinib hydrochloride in
patients with newly diagnosed GBM with unmethylated MGMT promoter treated with
bevacizumab and erlotinib hydrochloride after radiotherapy and temozolomide.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy (either intensity-modulated radiation therapy or 3-D conformal
radiotherapy) once daily 5 days a week and receive oral temozolomide concurrently with
radiotherapy once daily for 6 weeks (as planned). Patients whose tumor has a methylated MGMT
promoter are removed from study.
Approximately 4 weeks after completion of radiotherapy and temozolomide, patients receive
bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once
daily on days 1-28. Treatment with bevacizumab and erlotinib hydrochloride repeats every 4
weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at approximately 30 days and then
every 3 months thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease status will be assessed every 3 months by CT or MRI.
Every 3 months following the end of treatment due to disease progression
Jeffrey J. Raizer, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|M.D. Anderson Cancer Center at Orlando||Orlando, Florida 32806|
|Evanston Hospital||Evanston, Illinois 60201-1781|
|Northwestern University, Northwestern Medical Faculty Foundation||Chicago, Illinois 60611-3013|
|The Methodist Hospital Neurological Institute||Houston, Texas 77030|
|Neuro-Oncology Associates at Baylor University Medical Center, Dallas||Dallas, Texas 75246|