A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
NCT ID: NCT00800202
Last Updated: 2014-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2009-04-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
bevacizumab [Avastin]
15mg/kg iv every 3 weeks
carboplatin
AUC6 iv every 3 weeks for 6 cycles
paclitaxel
200mg/m2 iv every 3 weeks for 6 cycles
2
bevacizumab [Avastin]
15mg/kg iv every 3 weeks
erlotinib [Tarceva]
150mg/day po
Interventions
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bevacizumab [Avastin]
15mg/kg iv every 3 weeks
carboplatin
AUC6 iv every 3 weeks for 6 cycles
erlotinib [Tarceva]
150mg/day po
paclitaxel
200mg/m2 iv every 3 weeks for 6 cycles
Eligibility Criteria
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Inclusion Criteria
* stage IV non-squamous non-small cell lung cancer;
* asymptomatic, untreated brain metastasis;
* ECOG performance status 0-1.
Exclusion Criteria
* history of migraine or epilepsy;
* previous treatment with angiogenesis inhibitors;
* for cohort 2, previous first line treatment with Avastin or Tarceva;
* current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bordeaux, , France
Brest, , France
Caen, , France
Chartres, , France
Créteil, , France
Gap, , France
Gleizé, , France
La Tronche, , France
Lille, , France
Lyon, , France
Marseille, , France
Marseille, , France
Montpellier, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Rennes, , France
Saint-Herblain, , France
Strasbourg, , France
Toulon, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Countries
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Other Identifiers
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2008-006504-33
Identifier Type: -
Identifier Source: secondary_id
ML21823
Identifier Type: -
Identifier Source: org_study_id