Status:
TERMINATED
Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00749567
Start Date
July 1 2008
End Date
September 1 2010
Last Update
September 28 2015
Active Locations (10)
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1
University Hospital of Heraklion
Heraklion, Crete, Greece
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
401 Military Hospital, Medical Oncology Unit
Athens, Greece