Back to resultsCombination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer
Primary Purpose
Non-small-cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Erlotinib
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring NSCLC, TKI's, Anti-VEGF
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
Sites / Locations
- University Hospital of Heraklion
- University General Hospital of Alexandroupolis, Dep of Medical Oncology
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
- 401 Military Hospital, Medical Oncology Unit
- Air Forces Military Hospital, Dep of Medical Oncology
- IASO" General Hospital of Athens, 1st Dep of Medical Oncology
- Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
- Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
- "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
- Theagenion" Anticancer Hospital of Thessaloniki
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Erlotinib/Bevacizumab
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Progression Free Survival
Overall Survival
Quality of life assessment
Toxicity profile
Full Information
NCT ID
NCT00749567
First Posted
September 8, 2008
Last Updated
September 25, 2015
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
1. Study Identification
Unique Protocol Identification Number
NCT00749567
Brief Title
Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
NSCLC, TKI's, Anti-VEGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Erlotinib/Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
1 year
Title
Overall Survival
Time Frame
1 year
Title
Quality of life assessment
Time Frame
Assessment every two cycles
Title
Toxicity profile
Time Frame
Assessment every two cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Agelaki, MD
Organizational Affiliation
University Hospital of Crete, Dep of Medical Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manolis Kontopodis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Heraklion
City
Heraklion
State/Province
Crete
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
401 Military Hospital, Medical Oncology Unit
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
Theagenion" Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer
We'll reach out to this number within 24 hrs