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

Non-small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00749567
• Other study ID #: CT/08.15
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2008
• Last updated: September 25, 2015
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• Erlotinib
Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity
• Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity

Locations

Country	Name	City	State
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	University Hospital of Heraklion	Heraklion	Crete
Greece	"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology	Piraeus
Greece	Theagenion" Anticancer Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Objective responses confirmed by CT or MRI (on 3rd and	No
Secondary	Progression Free Survival		1 year	No
Secondary	Overall Survival		1 year	No
Secondary	Quality of life assessment		Assessment every two cycles	No
Secondary	Toxicity profile		Assessment every two cycles	Yes