CompletedPhase 2NCT00553800
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedbevacizumab and Erlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 12, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Fox Chase Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Fox Chase Cancer Center
Interventions being studied
Drug: bevacizumab; Drug: Erlotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • AtlantiCare Regional Medical CenterGalloway, New Jersey
  • Fox Chase Virtua Health Cancer Program at MemorialMount Holly, New Jersey
  • Paoli HospitalPaoli, Pennsylvania
  • Abramson Cnacer Center, University of PennsylvaniaPhiladelphia, Pennsylvania
  • Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania
  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania
  • Grand View HospitalSellersville, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 12, 2022. Always confirm current availability with the study team.

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