A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00451906
First received: March 22, 2007
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: Platinum-based chemotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of Avastin in Combination With Platinum-containing Chemotherapy as 1st Line Treatment in Patients With Stage IIIb/IV Non-squamous NSCLC

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of survival; time to disease progression. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 2118
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
Drug: Platinum-based chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
  • ECOG PS status 0-2;
  • life expectancy >= 12weeks;
  • adequate renal, liver and hematological function.

Exclusion Criteria:

  • mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
  • hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
  • evidence of tumor invading major blood vessels on imaging;
  • evidence of CNS metastases, even if previously treated.
  • major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
  • prior chemotherapy for stage IIIb/IV disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451906

  Hide Study Locations
Locations
Argentina
Buenos Aires, Argentina, 1272
Chaco-resistencia, Argentina, 3400
Cordoba, Argentina, 5000
Córdoba, Argentina, 5016
Mar Del Plata, Argentina, 7600
Tucuman, Argentina, T400IAK
Australia, New South Wales
St. Leonards, New South Wales, Australia, 2065
Wahroonga, New South Wales, Australia, 2076
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Chermside, Queensland, Australia, 4032
Tugun, Queensland, Australia, 4224
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Geelong, Victoria, Australia, 3220
Malvern, Victoria, Australia, 3144
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Perth, Western Australia, Australia, 6008
Austria
Bludenz, Austria, 6700
Bludesch, Austria, 6712
Bregenz, Austria, 6900
Dornbirn, Austria, 6850
Graz, Austria, 8036
Hall in Tirol, Austria, 6060
Hohenems, Austria, 6845
Innsbruck, Austria, 6020
Knittelfeld, Austria, 8720
Kufstein, Austria, 6330
Linz, Austria, 4020
Linz, Austria, 4010
Natters, Austria, 6161
Rankweil, Austria, 6830
Ried-innkreis, Austria, 4910
Salzburg, Austria, 5020
St Pölten, Austria, 3100
St Veit An Der Glan, Austria, 9300
Steyr, Austria, 4400
Vöcklabruck, Austria, 4840
Wels, Austria, 4600
Wien, Austria, 1130
Wien, Austria, 1140
Wien, Austria, 1030
Wien, Austria, 1145
Wien, Austria, 1160
Wien, Austria, 1090
Wiener Neustadt, Austria, 2700
Zams, Austria, 6511
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Salvador, BA, Brazil, 40170-110
Salvador, BA, Brazil, 41950-610
Fortaleza, CE, Brazil, 60125-151
Fortaleza, CE, Brazil, 60741-420
Vitoria, ES, Brazil, 29055-270
Goiania, GO, Brazil, 74140-050
Belo Horizonte, MG, Brazil, 30150-320
Belo Horizonte, MG, Brazil, 30140-083
Recife, PE, Brazil, 52012-220
Curitiba, PR, Brazil, 80730-180
Curitiba, PR, Brazil, 80530-010
Niteroi, RJ, Brazil, 24220-007
Rio de Janeiro, RJ, Brazil, 22640-000
Rio de Janeiro, RJ, Brazil, 22271-110
Rio De Janeiro, RJ, Brazil, 22290-160
Rio De Janeiro, RJ, Brazil, 22031072
Rio de Janeiro, RJ, Brazil, 21941-590
Ijui, RS, Brazil, 98700-000
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90020-090
Porto Alegre, RS, Brazil, 90430-090
Porto Alegre, RS, Brazil, 90610-000
Porto Alegre, RS, Brazil, 90110-270
Florianopolis, SC, Brazil, 88034-000
Campinas, SP, Brazil, 13060-803
Campinas, SP, Brazil, 13073-400
Jau, SP, Brazil, 17210-080
Piracicaba, SP, Brazil, 13419-155
Ribeirao Preto, SP, Brazil, 14025-270
Santos, SP, Brazil, 11075-350
Sao Paulo, SP, Brazil, 01332-000
Sao Paulo, SP, Brazil, 01308-050
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 04537-080
Sao Paulo, SP, Brazil, 01232-010
Sao Paulo, SP, Brazil, 01323-020
Sao Paulo, SP, Brazil, 05401-400
Sao Paulo, SP, Brazil, 01509-010
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 03102-002
Sao Paulo, SP, Brazil, 08270-070
Sorocaba, SP, Brazil, 18030-245
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H2L 4M1
China
Beijing, China, 101149
Beijing, China, 100021
Beijing, China, 100730
Guangzhou, China, 510080
Guangzhou, China, 510060
Hangzhou, China, 310022
Shanghai, China, 200032
Shanghai, China, 200433
Colombia
Bogota, Colombia
Cali, Colombia
Manizales, Colombia
Czech Republic
Brno, Czech Republic, 626 91
Plzen, Czech Republic, 305 99
Praha, Czech Republic, 150 06
Denmark
Herlev, Denmark, 2730
Hillerod, Denmark, 3400
Naestved, Denmark, 4700
Århus, Denmark, 8000
Ecuador
Guayaquil, Ecuador, EC090112
Quito, Ecuador, EC170124
Egypt
Cairo, Egypt, 11796
Cairo, Egypt, 11737
Estonia
Tallinn, Estonia, 13419
Tartu, Estonia, 50406
Finland
Helsinki, Finland, 00290
Oulu, Finland, 90029
Paimio, Finland, 21540
Pori, Finland, 28500
Tampere, Finland, 33520
France
Aix En Provence, France, 13616
Angers, France, 49933
Avignon, France, 84918
Besancon, France, 25030
Beziers, France, 34525
Bordeaux, France, 33077
Bordeaux, France, 33076
Brest, France, 29200
Caen, France, 14076
Caen, France, 14033
Chalon Sur Saone, France, 71100
Clermont Ferrand, France, 63050
Clermont-ferrand, France, 63003
Denain, France, 59723
Draguignan, France, 83007
GAP, France, 05007
Grenoble, France, 38043
Hyeres, France, 83400
Le Chesnay, France, 78157
Lille, France, 59020
Lille, France, 59042
Lille, France, 59037
Lyon, France, 69317
Lyon, France, 69365
Marseille, France, 13285
Marseille, France, 13274
Marseille, France, 13273
Meaux, France, 77104
Nancy, France, 54100
Neuilly Sur Seine, France, 92200
Paris, France, 75571
Paris, France, 75674
Paris, France, 75231
Perpignan, France, 66012
Reims, France, 51056
Roubaix, France, 59056
Saint-priest-en-jarez, France, 42270
St Julien En Genevois, France, 74164
Strasbourg, France, 67091
Strasbourg, France, 67065
Toulon, France, 83056
Toulon, France, 83041
Toulouse, France, 31059
Valenciennes, France, 59326
Vandoeuvre Les Nancy, France, 54511
Germany
Augsburg, Germany, 86150
Bad Berka, Germany, 99437
Bayreuth, Germany, 95445
Berlin, Germany, 13125
Berlin, Germany, 13353
Berlin, Germany, 12203
Bielefeld, Germany, 33604
Bonn, Germany, 53113
Coswig, Germany, 01640
Donaustauf, Germany, 93093
Düsseldorf, Germany, 40225
Ebensfeld, Germany, 96250
Erlangen, Germany, 91054
Essen, Germany, 45122
Frankfurt, Germany, 60488
Freiburg, Germany, 79106
Gauting, Germany, 82131
Gerlingen, Germany, 70839
Giessen, Germany, 35392
Grosshansdorf, Germany, 22927
Göttingen, Germany, 37075
Halle (Saale), Germany, 06120
Hamburg, Germany, 21075
Hamburg, Germany, 22081
Hannover, Germany, 30625
Hannover, Germany, 30171
Hemer, Germany, 58675
Karlsruhe, Germany, 76137
Kiel, Germany, 24116
Köln, Germany, 50677
Leer, Germany, 26789
Leipzig, Germany, 04207
Leverkusen, Germany, 51375
Löwenstein, Germany, 74245
Magdeburg, Germany, 39120
Mainz, Germany, 55131
Merzig, Germany, 66663
Minden, Germany, 32429
Muenchen, Germany, 80336
Neuruppin, Germany, 16816
Nürnberg, Germany, 90419
Oldenburg, Germany, 26121
Rostock, Germany, 18055
Treuenbrietzen, Germany, 14929
Ulm, Germany, 89081
Villingen-Schwenningen, Germany, 78052
Wiesbaden, Germany, 65199
Wolfsburg, Germany, 38440
Wuerselen, Germany, 52146
Hong Kong
Hong Kong, Hong Kong
Hong Kong, Hong Kong, 852
Hungary
Budapest, Hungary, 1529
Deszk, Hungary, 6772
Mátraháza, Hungary, 3233
Pecs, Hungary, 7635
Szombathely, Hungary, 9700
Torokbalint, Hungary, 2045
Iceland
Reykjavik, Iceland, 101
Israel
Beer Sheva, Israel, 8410101
Haifa, Israel, 34354
Jerusalem, Israel, 91120-01
Jerusalem, Israel, 91031
Kfar-Saba, Israel, 4428164
Petach Tikva, Israel, 49100
Ramat Gan, Israel, 52621
Tel Aviv, Israel, 6423906
Zerifin, Israel, 70300
Italy
Avezzano, Abruzzo, Italy, 67051
Chieti, Abruzzo, Italy, 66100
Pescara, Abruzzo, Italy, 65124
Potenza, Basilicata, Italy, 85100
Rionero in Vulture, Basilicata, Italy, 85028
Catanzaro, Calabria, Italy, 88100
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Carpi, Emilia-Romagna, Italy, 41012
Cattolica, Emilia-Romagna, Italy, 47841
Meldola, Emilia-Romagna, Italy, 47014
Modena, Emilia-Romagna, Italy, 41100
Rimini, Emilia-Romagna, Italy, 47900
Aviano, Friuli-Venezia Giulia, Italy, 33081
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00144
Roma, Lazio, Italy, 00151
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00152
Roma, Lazio, Italy, 00189
Sora, Lazio, Italy, 03039
Viterbo, Lazio, Italy, 01100
Genova, Liguria, Italy, 16132
Genova, Liguria, Italy, 16149
La Spezia, Liguria, Italy, 19100
Bergamo, Lombardia, Italy, 24128
Brescia, Lombardia, Italy, 25123
Cremona, Lombardia, Italy, 26100
Milano, Lombardia, Italy, 20157
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20162
Milano, Lombardia, Italy, 20142
Pavia, Lombardia, Italy, 27100
Rho, Lombardia, Italy, 20017
S Fermo Della Battaglia, Lombardia, Italy, 22020
Sondrio, Lombardia, Italy, 23100
Ancona, Marche, Italy
Asti, Piemonte, Italy, 14100
Ivrea, Piemonte, Italy, 10015
Novara, Piemonte, Italy, 28100
Torino, Piemonte, Italy, 10126
Bari, Puglia, Italy, 70124
Brindisi, Puglia, Italy, 72100
San Giovanni Rotondo, Puglia, Italy, 71013
Cagliari, Sardegna, Italy, 09121
Sassari, Sardegna, Italy, 07100
Catania, Sicilia, Italy, 95100
Catania, Sicilia, Italy, 95122
Messina, Sicilia, Italy, 98123
Palermo, Sicilia, Italy, 90127
Taormina, Sicilia, Italy, 98030
Viagrande, Sicilia, Italy, 95029
Arezzo, Toscana, Italy, 52100
Carrara, Toscana, Italy, 54033
Lido Di Camaiore, Toscana, Italy, 55043
Pisa, Toscana, Italy, 56100
Perugia, Umbria, Italy, 06156
Camposampiero, Veneto, Italy, 35012
Feltre - Bl, Veneto, Italy, 32032
Mirano, Veneto, Italy, 30035
Negrar, Veneto, Italy, 37024
Venezia, Veneto, Italy, 30122
Latvia
Riga, Latvia, LV-1002
Riga, Latvia, LV 1079
Lebanon
Beirut, Lebanon, 99999
Lithuania
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 92288
Vilnius, Lithuania, 08660
Mexico
Chihuahua, Mexico, 31000
Leon, Mexico, 37000
Mexico City, Mexico, 14080
Mexico City, Mexico, 16200
Mexico City, Mexico, 14140
Monterrey, Mexico, 66260
Tijuana, Mexico, 22320
Netherlands
Arnhem, Netherlands, 6815 AD
Boxmeer, Netherlands, 5831 HA
Breda, Netherlands, 4818 CK
Den Haag, Netherlands, 2504 LN
Eindhoven, Netherlands, 5623 EJ
Groningen, Netherlands, 9728 NZ
Haarlem, Netherlands, 2035 RC
Helmond, Netherlands, 5700 AB
Hoofddorp, Netherlands, 2134 TM
Leiden, Netherlands, 2333 ZA
Nieuwegein, Netherlands, 3435 CM
Schiedam, Netherlands, 3116 BA
Tiel, Netherlands, 4002 WP
Zwolle, Netherlands, 8011 JW
Poland
Bialystok, Poland, 15-540
Krakow, Poland, 31-115
Lublin, Poland, 02-090
Poznan, Poland, 60-569
Warszawa, Poland, 02-097
Warszawa, Poland, 01-138
Warszawa, Poland, 02-781
Warszawa, Poland, 00-909
Wroclaw, Poland, 53-439
Zabrze, Poland, 41-843
Portugal
Almada, Portugal, 2801-951
Braga, Portugal, 4710-243
Cascais, Portugal, 2750-349
Coimbra, Portugal, 3041-801
Covilhã, Portugal, 6200
Lisboa, Portugal, 1600
Lisboa, Portugal, 1099-023
Lisboa, Portugal, 1796-001
Porto, Portugal, 4200
Porto, Portugal, 4200-072
Santa Maria Da Feira, Portugal, 4520-211
Setubal, Portugal, 2910-446
Vila Nova De Gaia, Portugal, 4434-502
Romania
Bucharest, Romania, 010816
Bucuresti, Romania, 022328
Cluj Napoca, Romania, 400015
Cluj-Napoca, Romania, 400006
Iasi, Romania, 6600
Timisoara, Romania, 1900
Russian Federation
Balashikha, Russian Federation, 143900
Barnaul, Russian Federation, 656049
Ekaterinburg, Russian Federation, 620905
Engels, Russian Federation, 413115
Irkutsk, Russian Federation, 664035
Izhevsk, Russian Federation, 426009
Kazan, Russian Federation, 420111
Kazan, Russian Federation, 420029
Krasnodar, Russian Federation, 350086
Kursk, Russian Federation, 305035
Moscow, Russian Federation, 119992
Moscow, Russian Federation, 143423
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 107005
Samara, Russian Federation, 443031
Smolensk, Russian Federation, 214000
St Petersburg, Russian Federation, 197022
Stavropol, Russian Federation, 355047
Tumen, Russian Federation, 625047
Tver, Russian Federation, 170008
UFA, Russian Federation, 450054
Ulyanovsk, Russian Federation, ND
Serbia
Belgrade, Serbia, 11000
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 825 56
Bratislava, Slovakia, 833 10
Kosice, Slovakia, 041 90
Nitra, Slovakia, 949 88
Poprad, Slovakia, 058 87
Slovenia
Golnik, Slovenia
Ljubljana, Slovenia, 1000
Spain
Alcoy, Alicante, Spain, 03804
Elche, Alicante, Spain, 03203
Manresa, Barcelona, Spain, 08243
Mataro, Barcelona, Spain, 08304
Sabadell, Barcelona, Barcelona, Spain, 08208
Terrassa, Barcelona, Spain, 08221
Santander, Cantabria, Spain, 39008
Palma De Mallorca, Islas Baleares, Spain, 07014
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Alcorcon, Madrid, Spain, 28922
Pamplona, Navarra, Spain, 31008
La Laguna, Tenerife, Spain, 38320
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Barakaldo, Vizcaya, Spain, 48903
Alicante, Spain, 3010
Barcelona, Spain, 08916
Barcelona, Spain, 08022
Barcelona, Spain, 08036
Barcelona, Spain, 08041
Barcelona, Spain, 08907
Burgos, Spain, 09006
Caceres, Spain, 10003
Girona, Spain, 17007
Huesca, Spain, 22004
La Coruña, Spain, 15006
Lugo, Spain, 27004
Madrid, Spain, 28041
Madrid, Spain, 28002
Madrid, Spain, 28040
Madrid, Spain, 28034
Madrid, Spain, 28046
Madrid, Spain, 28222
Murcia, Spain, 30008
Pontevedra, Spain, 36002
Salamanca, Spain, 37007
Valencia, Spain, 46009
Valencia, Spain, 46010
Valencia, Spain, 46026
Valencia, Spain, 41014
Valencia, Spain, 46015
Zaragoza, Spain, 50009
Sweden
Goteborg, Sweden, 40036
Linkoeping, Sweden, 58185
Lund, Sweden, 22185
Malmoe, Sweden, 20502
Oerebro, Sweden, 70185
Stokholm, Solna, Sweden, 17176
Umea, Sweden, 90185
Uppsala, Sweden, 751 85
Switzerland
Aarau, Switzerland, 5000
Baden, Switzerland, 5404
Biel, Switzerland, 2502
Genolier, Switzerland, 1272
Locarno, Switzerland, 6601
Taiwan
Taichung, Taiwan, 407
Tainan, Taiwan, 704
Taipei, Taiwan
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Turkey
Ankara, Turkey, 06500
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34126
Istanbul, Turkey, 34383
Izmir, Turkey, 35340
S?hhiye, ANKARA, Turkey, 06100
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Belfast, United Kingdom, BT9 7AB
Birmingham, United Kingdom, B9 5SS
Cambridge, United Kingdom, CB2 2QQ
Cardiff, United Kingdom, CF14 2TL
Chelmsford, United Kingdom, CM1 7ET
Manchester, United Kingdom, M23 9LT
Nottingham, United Kingdom, NG5 1PB
Peterborough, United Kingdom, PE 3 9GZ
Venezuela
Barcelona, Venezuela, 6001
Barquisimeto, Venezuela, 3001
Porlamar, Venezuela, 6301
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00451906     History of Changes
Other Study ID Numbers: MO19390
Study First Received: March 22, 2007
Last Updated: April 7, 2014
Health Authority: Austria: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014