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

NCT ID: NCT00749567

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-09-30

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.

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.

Conditions

Non-small-cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Erlotinib/Bevacizumab

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity

Bevacizumab

Intervention Type: DRUG

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity

Interventions

Erlotinib

Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity

Intervention Type: DRUG

Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity

Intervention Type: DRUG

Other Intervention Names

Tarceva; Avastin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sofia Agelaki, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Manolis Kontopodis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Locations

University Hospital of Heraklion

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , 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

Countries

Greece

Other Identifiers

CT/08.15

Identifier Type: -

Identifier Source: org_study_id