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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00445588 |
RATIONALE: Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: erlotinib hydrochloride Drug: sorafenib tosylate Genetic: gene expression analysis Genetic: mutation analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: mass spectrometry Other: pharmacological study Procedure: biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Erlotinib (OSI-774) and Sorafenib (BAY 43-9006) for Patients With Progression or Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 56 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary:
Secondary
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.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial glioblastoma multiforme
PATIENT CHARACTERISTICS:
No concurrent serious infection or medical illness that would preclude study treatment or patient safety including, but not limited to, the following:
Uncontrolled hypertension, defined as systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
No known corneal abnormalities, including the following:
No condition that would preclude the ability to swallow pills, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 10 days since prior and concurrent cytochrome P450-inducing anticonvulsants including, but not limited to, the following:
Concurrent full-dose anticoagulants allowed provided the following criteria are met:
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | David M. Peereboom, MD | Case Comprehensive Cancer Center |
Responsible Party: | New Approaches to Brain Tumor Therapy ( Stuart A. Grossman ) |
Study ID Numbers: | CDR0000531731, NABTT-0502 |
Study First Received: | March 7, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00445588 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult giant cell glioblastoma recurrent adult brain tumor adult gliosarcoma adult glioblastoma |
Erlotinib Glioblastoma Astrocytoma Disease Progression Central Nervous System Neoplasms Protein Kinase Inhibitors Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Sorafenib Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Erlotinib Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Enzyme Inhibitors Central Nervous System Neoplasms Protein Kinase Inhibitors |
Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Sorafenib Nervous System Neoplasms Neoplasms, Glandular and Epithelial |