AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
NCT ID: NCT00961415
Last Updated: 2016-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
376 participants
INTERVENTIONAL
2009-08-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1
bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3-week cycle
cisplatin
75mg/m2 iv on day 1 of each 3-week cycle
pemetrexed
500mg/m2 iv on day 1 of each 3-week cycle
Part 2A
bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3-week cycle
Part 2B
bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3-week cycle
pemetrexed
500mg/m2 iv on day 1 of each 3-week cycle
Interventions
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bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3-week cycle
cisplatin
75mg/m2 iv on day 1 of each 3-week cycle
pemetrexed
500mg/m2 iv on day 1 of each 3-week cycle
Eligibility Criteria
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Inclusion Criteria
* inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
* at least 1 measurable lesion meeting RECIST criteria
* ECOG performance status 0-2
* adequate hematological, liver and renal function
Exclusion Criteria
* malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
* evidence of tumor invading major blood vessels
* current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
* history of haemoptysis \>/=grade 2
* clinically significant cardiovascular disease
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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Béziers, , France
Bordeaux, , France
Bron, , France
Caen, , France
Caen, , France
Clermont-Ferrand, , France
Créteil, , France
Gap, , France
Gleizé, , France
La Source, , France
La Tronche, , France
Lille, , France
Limoges, , France
Lyon, , France
Marseille, , France
Nancy, , France
Nîmes, , France
Paris, , France
Paris, , France
Paris, , France
Perpignan, , France
Pierre-Bénite, , France
Reims, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Toulon, , France
Tours, , France
Augsburg, , Germany
Bad Berka, , Germany
Berlin, , Germany
Bonn, , Germany
Ebensfeld, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Gauting, , Germany
Großhansdorf, , Germany
Halle, , Germany
Hamburg, , Germany
Immenhausen, , Germany
Karlsruhe, , Germany
Leipzig, , Germany
Minden, , Germany
München, , Germany
Oldenburg, , Germany
Alexandroupoli, , Greece
Lecce, Apulia, Italy
Napoli, Campania, Italy
Aviano, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Novara, Piedmont, Italy
Sassari, Sardinia, Italy
Pisa, Tuscany, Italy
Padua, Veneto, Italy
's-Hertogenbosch, , Netherlands
Amersfoort, , Netherlands
Amsterdam, , Netherlands
Breda, , Netherlands
Eindhoven, , Netherlands
Haarlem, , Netherlands
Nieuwegein, , Netherlands
Rotterdam, , Netherlands
Sittard-Geleen, , Netherlands
The Hague, , Netherlands
Zaandam, , Netherlands
Balashikha, , Russia
Irkutsk, , Russia
Krasnodar, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Bundang City, , South Korea
Daegu, , South Korea
Gyeonggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Palma de Mallorca, Balearic Islands, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Gävle, , Sweden
Linköping, , Sweden
Lund, , Sweden
Uppsala, , Sweden
Zurich, , Switzerland
Antalya, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Al Ain City, , United Arab Emirates
Countries
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References
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Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8.
Other Identifiers
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2008-007008-27
Identifier Type: -
Identifier Source: secondary_id
MO22089
Identifier Type: -
Identifier Source: org_study_id
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