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

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborators: Genentech, Inc.; OSI Pharmaceuticals
• Treatments: Bevacizumab; Erlotinib Hydrochloride

Criteria

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
• 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