Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
NCT ID: NCT00553800
Last Updated: 2022-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2007-07-05
2011-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bevacizumab & Erlotinib
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
bevacizumab
Erlotinib
Interventions
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bevacizumab
Erlotinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG PS 0-1
* 70 years of age or older
* Must have measurable disease
* ANC \> 1500, platelets \> 100,000
* Total bilirubin \</= 1.5, SGOT \* SGPT \< 5 x ULN
* Able and willing to swallow and absorb oral medication
* Able and willing to sign consent
* Request archival diagnostic tissue for EGFR expression but not required
Exclusion Criteria
* Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
* Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
* History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
* Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
* Current, ongoing treatment with full dose warfarin or equivalent
* Current(within 10 days)use of aspirin (\> 325mg/day) or other NSAID with antiplatelet activity
* History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD
* Known CNS disease except for treated brain mets.
* Squamous cell histology
* Blood pressure \> 150/100 that cannot be ameliorated with standard anti-hypertensives
* History of hypertensive crisis or hypertensive encephalopathy
* NYHA grade II or \> CHF
* History of MI within 6 months of enrollment
* Major surgery, open biopsy, significant trauma within 28 days of enrollment
* Pregnancy, lactation
* Abdominal or other fistula, abcess, perforation
70 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
OSI Pharmaceuticals
INDUSTRY
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Hossein Borghaei, DO
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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AtlantiCare Regional Medical Center
Galloway, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Memorial
Mount Holly, New Jersey, United States
Paoli Hospital
Paoli, Pennsylvania, United States
Abramson Cnacer Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
Countries
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References
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Phase II study of bevacizumab and erlotinib in treatment-naïve elderly patients (older than age 65) with advanced non-small cell lung cancer (NSCLC). H. Borghaei, R. Mehra, M. M. Millenson, H. Tuttle, K. Ruth, A. J. Magdalinski, D. M. Mintzer, J. W. Lee, G. R. Simon, and C. J. Langer Journal of Clinical Oncology 2010 28:15_suppl, e18019-e18019
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FER-TH-007
Identifier Type: -
Identifier Source: org_study_id
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