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Sponsors and Collaborators: |
Duke University Genentech |
---|---|
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00671970 |
Primary objective:
To estimate 6-month progression free survival probability of pts w recurrent malignant gliomas treated w erlotinib + bevacizumab.
Secondary Objectives:
To evaluate safety & tolerability of erlotinib + bevacizumab among pts w recurrent malignant gliomas To evaluate radiographic response of pts w recurrent malignant gliomas treated w erlotinib + bevacizumab To evaluate pharmacokinetics of erlotinib when administered to pts w recurrent malignant gliomas; & to examine relationship of clinical response to EGFR expression, amplification, & v-III mutation, PTEN expression, VEGF expression & phosphorylated PKB/Akt in archival tumor samples
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Gliosarcoma |
Drug: Bevacizumab and Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma |
Estimated Enrollment: | 56 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Pts w recurrent GBM
|
Drug: Bevacizumab and Erlotinib
Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. Dose of erlotinib is based on prior erlotinib monotherapy trial in RMG. It will be 200 mg/day for pts not on CYP3A4-enzyme inducing anti-epileptic drugs & 650 mg/day for pts on EIAEDs. It is possible that taking erlotinib w regular medications or supplements may change how erlotinib, subject's regular medications, or subject's regular supplements work. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent. |
B: Experimental
Pts w recurrent anaplastic glioma
|
Drug: Bevacizumab and Erlotinib
Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. Dose of erlotinib is based on prior erlotinib monotherapy trial in RMG. It will be 200 mg/day for pts not on CYP3A4-enzyme inducing anti-epileptic drugs & 650 mg/day for pts on EIAEDs. It is possible that taking erlotinib w regular medications or supplements may change how erlotinib, subject's regular medications, or subject's regular supplements work. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent. |
Exploratory, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of erlotinib + bevacizumab among pts w recurrent malignant glioma. Signal transduction inhibitors, such as erlotinib, as well as anti-angiogenic agents, such as bevacizumab, are expected to exert a cytostatic anti-tumor effect. Primary endpoint of study is probability of progression-free survival at 6 months. An important secondary objective is to further assess the safety of erlotinib + bevacizumab for pts w RMG. Pharmacokinetic studies included in protocol will evaluate impact of EIAEDs on metabolism of erlotinib.
If study demonstrates that combo regimen of erlotinib + bevacizumab is associated w encouraging anti-tumor activity among pts w RMG, further assessment of regimen in additional ph II & possibly ph III studies, will be considered.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David A. Reardon, MD | (919) 668-1409 | david.reardon@duke.edu |
Contact: KAREN Carter | (919) 668-2329 | Karen.Carter@duke.edu |
United States, North Carolina | |
Duke University Health System | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: David A. Reardon, MD 919-668-1409 david.reardon@duke.edu | |
Contact: Raquel Newell (919) 681-3229 raquel.newell@duke.edu |
Principal Investigator: | David A. Reardon, MD | Duke University Health System |
Responsible Party: | Duke University Health System ( David A. Reardon, MD ) |
Study ID Numbers: | 00000220 |
Study First Received: | January 29, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00671970 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Gliosarcoma Recurrent MG Malignant glioma Glioma GBM Brain tumor |
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic oligoastrocytoma Bevacizumab Avastin Erlotinib Tarceva |
Erlotinib Glioblastoma Astrocytoma Bevacizumab Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Neoplasms, Neuroepithelial |