Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments bevacizumab, erlotinib
Phase phase 2
Targets EGFR, VEGF
Sponsor Fox Chase Cancer Center
Collaborator Genentech, Inc.
Start date March 2007
End date October 2013
Trial size 33 participants
Trial identifier NCT00553800, FER-TH-007

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
bevacizumab Other names: Avastin
erlotinib Other name: Tarceva

Primary Outcomes

Measure
Efficacy measure is progression free survival defined as the time from enrollment to documented progression of disease by radiologic imaging.
time frame: Scans to be done after every 2nd cycle of treatment

Secondary Outcomes

Measure
toxicity
time frame: every 3 weeks at day 1 physician exam and in between as needed

Eligibility Criteria

Male or female participants at least 70 years old.

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 /= 1.0 - 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

Additional Information

Official title Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
Principal investigator Hossein Borghaei, DO
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Fox Chase Cancer Center.