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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749567
Recruitment Status : Terminated (Poor accrual)
First Posted : September 9, 2008
Last Update Posted : September 28, 2015
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Erlotinib Drug: Bevacizumab Phase 2

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  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]
  2. Overall Survival [ Time Frame: 1 year ]
  3. Quality of life assessment [ Time Frame: Assessment every two cycles ]
  4. Toxicity profile [ Time Frame: Assessment every two cycles ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749567

University Hospital of Heraklion
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, 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
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, Greece
Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Sofia Agelaki, MD University Hospital of Crete, Dep of Medical Oncology
Principal Investigator: Manolis Kontopodis, MD University Hospital of Crete

Responsible Party: Hellenic Oncology Research Group Identifier: NCT00749567     History of Changes
Other Study ID Numbers: CT/08.15
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Hellenic Oncology Research Group:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action