Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
NSCLC
Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
1 other identifier
interventional
32
1 country
7
Brief Summary
This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2007
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2007
CompletedFirst Submitted
Initial submission to the registry
November 5, 2007
CompletedFirst Posted
Study publicly available on registry
November 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
July 12, 2022
CompletedJuly 12, 2022
June 1, 2022
3.5 years
November 5, 2007
May 25, 2022
June 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
3 years
Study Arms (1)
Bevacizumab & Erlotinib
EXPERIMENTALbevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
Interventions
Eligibility Criteria
You may qualify if:
- Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
- ECOG PS 0-1
- 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
You may not qualify if:
- Proteinuria as demonstrated by UPC ratio \>/= 1.0
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fox Chase Cancer Centerlead
- Genentech, Inc.collaborator
- OSI Pharmaceuticalscollaborator
Study Sites (7)
AtlantiCare Regional Medical Center
Galloway, New Jersey, 08205, United States
Fox Chase Virtua Health Cancer Program at Memorial
Mount Holly, New Jersey, 08060, United States
Paoli Hospital
Paoli, Pennsylvania, 19301, United States
Abramson Cnacer Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Grand View Hospital
Sellersville, Pennsylvania, 18960, United States
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hossein Borghaei
- Organization
- Hossein.Borghaei@fccc.edu
Study Officials
- PRINCIPAL INVESTIGATOR
Hossein Borghaei, DO
Fox Chase Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2007
First Posted
November 6, 2007
Study Start
July 5, 2007
Primary Completion
January 12, 2011
Study Completion
June 1, 2011
Last Updated
July 12, 2022
Results First Posted
July 12, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share