Clinical trial NCT00806923: A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official title: A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 1044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* 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:

* prior chemotherapy or treatment with another systemic cancer therapy;
* 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: Event driven
Secondary outcomes:
measure: Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
timeFrame: Event driven
measure: Safety:AEs, laboratory tests, SAEs, coagulation parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Mendoza
country: Argentina
city: San Miguel de Tucuman
country: Argentina
city: Santa Fe
country: Argentina
city: Santa Fe
country: Argentina
city: Adelaide
country: Australia
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Canberra
country: Australia
city: Kurralta Park
country: Australia
city: Melbourne
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Sydney
country: Australia
city: Sydney
country: Australia
city: Tugun
country: Australia
city: Wollongong
country: Australia
city: Bruxelles
country: Belgium
city: Haine-saint-paul
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Belo Horizonte
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Moncton
country: Canada
state: New Brunswick
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Sainte-foy
country: Canada
state: Quebec
city: Ostrava
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Usti Nad Labem
country: Czech Republic
city: Belfort
country: France
city: Bobigny
country: France
city: Caen
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montbeliard
country: France
city: Montpellier
country: France
city: Pierre Benite
country: France
city: Rennes
country: France
city: Rouen
country: France
city: St Herblain
country: France
city: Strasbourg
country: France
city: Vandoeuvre Les Nancy
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Gauting
country: Germany
city: Göttingen
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Hemer
country: Germany
city: Karlsruhe
country: Germany
city: Leverkusen
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Mosdos
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szombathely
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Ramat-gan
country: Israel
city: Tel Aviv
country: Israel
city: Candiolo
country: Italy
city: Catania
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Parma
country: Italy
city: Perugia
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Rozzano
country: Italy
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Balashikha
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Alicante
country: Spain
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: La Laguna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Kueishan
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Guildford
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Sutton
country: United Kingdom
city: Yeovil
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.