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

NCT00749567 | Terminated Phase 2

• 1 other identifier: CT/08.15
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 10

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.

Conditions

Non-small-cell Lung Cancer

Keywords

NSCLC; TKI's; Anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Objective responses confirmed by CT or MRI (on 3rd and

Secondary Outcomes (4)

• Progression Free Survival

  1 year

• Overall Survival

  1 year

• Quality of life assessment

  Assessment every two cycles

• Toxicity profile

  Assessment every two cycles

Study Arms (1)

1

EXPERIMENTAL

Erlotinib/Bevacizumab

Drug: Erlotinib; Drug: Bevacizumab

Interventions

Erlotinib DRUG

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

Also known as: Tarceva

1

Bevacizumab DRUG

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

Also known as: Avastin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (10)

University Hospital of Heraklion

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

Athens, Greece

Location

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

Piraeus, Greece

Location

Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sofia Agelaki, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

• Manolis Kontopodis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

GR (10)