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

Phase 2

Completed

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

Detailed Description: There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Bevacizumab & Erlotinib	bevacizumab	bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
Bevacizumab & Erlotinib	Erlotinib	bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	3 years	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

Secondary Outcome Measures

Name	Time	Method

Locations (7): AtlantiCare Regional Medical Center
🇺🇸
Galloway, New Jersey, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, 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
Grand View Hospital
🇺🇸
Sellersville, Pennsylvania, United States