A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00806923
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1044 participants
INTERVENTIONAL
2005-02-28
2011-02-28
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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1
Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
2
Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
3
Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Placebo
iv on day 1 of each 3 week cycle until disease progression
Interventions
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Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Placebo
iv on day 1 of each 3 week cycle until disease progression
bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
Eligibility Criteria
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Inclusion Criteria
* documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
* adequate liver and kidney function;
* women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.
Exclusion Criteria
* surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
* brain metastasis or spinal cord compression;
* fertile men, and women of childbearing potential, not using adequate contraception;
* treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
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_CHAIR
Hoffmann-La Roche
Locations
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Bahía Blanca, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mendoza, , Argentina
San Miguel de Tucumán, , Argentina
Santa Fe, , Argentina
Santa Fe, , Argentina
Adelaide, , Australia
Adelaide, , Australia
Brisbane, , Australia
Canberra, , Australia
Kurralta Park, , Australia
Melbourne, , Australia
Parkville, , Australia
Perth, , Australia
Sydney, , Australia
Sydney, , Australia
Tugun, , Australia
Wollongong, , Australia
Brussels, , Belgium
Haine-Saint-Paul, , Belgium
Leuven, , Belgium
Liège, , Belgium
Belo Horizonte, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Moncton, New Brunswick, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Ostrava, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Belfort, , France
Bobigny, , France
Caen, , France
Lyon, , France
Marseille, , France
Montbéliard, , France
Montpellier, , France
Pierre-Bénite, , France
Rennes, , France
Rouen, , France
Saint-Herblain, , France
Strasbourg, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Essen, , Germany
Gauting, , Germany
Göttingen, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Hemer, , Germany
Karlsruhe, , Germany
Leverkusen, , Germany
Mainz, , Germany
Mannheim, , Germany
München, , Germany
Alexandroupoli, , Greece
Athens, , Greece
Athens, , Greece
Thessaloniki, , Greece
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Budapest, , Hungary
Mosdós, , Hungary
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
Szombathely, , Hungary
Zalaegerszeg, , Hungary
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Candiolo, , Italy
Catania, , Italy
Genova, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Parma, , Italy
Perugia, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Roma, , Italy
Rozzano, , Italy
Gdansk, , Poland
Gdynia, , Poland
Lublin, , Poland
Olsztyn, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Balashikha, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Alicante, , Spain
Barakaldo, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
San Cristóbal de La Laguna, , Spain
Seville, , Spain
Seville, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Kueishan, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Guildford, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Sheffield, , United Kingdom
Sutton, , United Kingdom
Yeovil, , United Kingdom
Countries
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References
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Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.
Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.
Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.
Other Identifiers
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BO17704
Identifier Type: -
Identifier Source: org_study_id