Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor||Drug: erlotinib hydrochloride Drug: sorafenib tosylate Other: pharmacological study||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Erlotinib (OSI-774) and Sorafenib (BAY 43-9006) for Patients With Progression or Recurrent Glioblastoma Multiforme|
- Overall Survival [ Time Frame: Time of first day of the treatment to death, assessed up to 2 years ]death. measured by time of first day of treatment until date of death, assessed up to 2 years.
- 6months -Progression-free Survival Rate [ Time Frame: At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up ]defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up
|Study Start Date:||January 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study
Drug: erlotinib hydrochloride
150mg Given orally once daily
Other Name: OSI-774Drug: sorafenib tosylate
400mg Given orally twice daily
Other Name: BAY 3-9006Other: pharmacological study
I. The primary objective of this trial is to estimate the overall survival rate associated with this combined regimen in treating adult patients with recurrent glioblastoma multiforme.
I. To assess and estimate the toxicities. II. Tumor response rate. III. To estimate 6-month progression free survival. IV. To describe the pharmacokinetics of this route of administration. V. For the Molecular Targeted Combinations Correlative (MTC2) Study Initiative: To determine the relationship between tumor and blood biomarkers and clinical outcome of patients treated with the combination of targeted agents.
OUTLINE: This is a multicenter, open-label, phase II study.
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Tumor tissue and blood samples are collected prior to beginning treatment. Samples are analyzed by immunohistochemistry, gene expression, and DNA mutation and genomic analyses of the epidermal growth factor receptor, ras-raf-ERK, and PI3K-Akt-mTOR pathways to identify markers that correlate with patient outcomes. Blood samples are also collected on day 15 of course 1 for pharmacokinetic studies. Samples are analyzed by reversed-phase isocratic high-performance liquid chromatography with electrospray ionization mass spectrometry to determine the concentration of erlotinib hydrochloride and sorafenib tosylate and its known metabolites.
After completion of study therapy, patients are followed every 2 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445588
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||David Peereboom, MD||New Approaches to Brain Tumor Therapy Consortium|