Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer

September 25, 2015 updated by: Hellenic Oncology Research Group

Combination of Erlotinib (Tarceva®) and Bevacizumab (Avastin®) as Second-line Treatment in Locally Advanced / Metastatic, Non-squamous, Non-small Cell Lung Cancer (NSCLC) Patients: A Phase II Study

The purpose of this study is to evaluate the efficacy and toxicity of combination of erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one of the two agents would not excluded patients from the study, in order to evaluate whether the combination of the two biologic agents could reverse tumor resistance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A randomized, placebo-controlled phase III trial of erlotinib versus placebo, demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Moreover, the addition of bevacizumab, a monoclonal antibody against Vascular Endothelial Growth Factor bevacizumab (VEGF), to systemic chemotherapy, improved both the response rates and the time to tumor progression in two trials. Early data from phase I/II trials examining the combination of these two biological agents in pre-treated patients with non-squamous NSCLC, showed no major pharmacokinetic interactions and promising clinical activity.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • 401 Military Hospital, Medical Oncology Unit
      • Athens, Greece
        • Air Forces Military Hospital, Dep of Medical Oncology
      • Athens, Greece
        • IASO" General Hospital of Athens, 1st Dep of Medical Oncology
      • Athens, Greece
        • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
      • Athens, Greece
        • Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
      • Piraeus, Greece
        • "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
      • Thessaloniki, Greece
        • Theagenion" Anticancer Hospital of Thessaloniki
    • Crete
      • Heraklion, Crete, Greece
        • University Hospital of Heraklion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
  • Progression to first-line therapy for advanced/metastatic NSCLC
  • Bi-dimensionally measurable disease (not included in radiation field)
  • ECOG performance status of 0-2
  • Life expectancy of more than 6 months
  • Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine <1.5 times the upper normal limit),and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • Signed informed consent

Exclusion Criteria:

  • Central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
  • Presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
  • Surgery or radiation therapy within the last 14 days from study entry
  • Active infection
  • History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension
  • Patients on other experimental treatment protocols
  • History of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix)
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Erlotinib/Bevacizumab
Drug: Erlotinib
Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity
Other Names:
  • Tarceva
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and
Objective responses confirmed by CT or MRI (on 3rd and

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Quality of life assessment
Time Frame: Assessment every two cycles
Assessment every two cycles
Progression Free Survival
Time Frame: 1 year
1 year
Toxicity profile
Time Frame: Assessment every two cycles
Assessment every two cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Investigators

  • Principal Investigator: Manolis Kontopodis, MD, University Hospital of Crete

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/08.15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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