Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.

Key facts

Study ID

NCT00553800

Run by

Fox Chase Cancer Center

People needed

32

Starts

2007-07-05

Expected to finish

2011-06-01

Last updated by the study team

2022-07-12

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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
• Pregnancy, lactation
• Abdominal or other fistula, abcess, perforation

Where it is running

• 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

Full record on ClinicalTrials.gov

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