Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib works after radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
Brain and Central Nervous System Tumors
Drug: erlotinib hydrochloride
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation|
- Overall survival [ Time Frame: Every 3 months following the end of treatment due to disease progression ] [ Designated as safety issue: No ]Disease status will be assessed every 3 months by CT or MRI.
- Progression-free survival at 12 and 18 months [ Time Frame: At 12 and 18 months after ending study treatment due to disease progression ] [ Designated as safety issue: No ]Progression free survival will be assessed by CT or MRI
- Radiographic response rates [ Time Frame: Every 8 weeks during treatment ] [ Designated as safety issue: No ]Response will be measured by CT or MRI every 8 weeks during treatment.
- Safety of the combination of erlotinib and bevacizumab in this patient population [ Time Frame: Every 4 weeks during treatment and every 3 months during survival follow up ] [ Designated as safety issue: Yes ]Information on adverse events will be collected before every cycle and during follow up.
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
erlotinib and bevacizumab
10mg/kg administered intravenously every 2 weeks
Other Name: AvastinDrug: erlotinib hydrochloride
150 mg/daily orally
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720356
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|M.D. Anderson Cancer Center at Orlando|
|Orlando, Florida, United States, 32806-2134|
|United States, Illinois|
|Northwestern University, Northwestern Medical Faculty Foundation|
|Chicago, Illinois, United States, 60611-3013|
|Evanston, Illinois, United States, 60201-1781|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|Neuro-Oncology Associates at Baylor University Medical Center, Dallas|
|Dallas, Texas, United States, 75246|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|The Methodist Hospital Neurological Institute|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 19024|
|Principal Investigator:||Jeffrey J. Raizer, MD||Robert H. Lurie Cancer Center|