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 25, 2016
Last verified: April 2016
  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-Squamous Non-Small Cell Lung Cancer
Drug: Platinum-based chemotherapy
Drug: Bevacizumab [Avastin]
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants With Adverse Events of Special Interest [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.

  • Number of Participants With Serious Adverse Events Related to Bevacizumab [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.


Secondary Outcome Measures:
  • Duration of Overall Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.

  • Time to Disease Progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

  • Number of Participants With Central Nervous System Bleeding [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.


Enrollment: 2252
Study Start Date: August 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + Chemotherapy
Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
Drug: Platinum-based chemotherapy
As prescribed
Drug: Bevacizumab [Avastin]
15 mg/kg IV on Day 1 of each 3 week cycle

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Tucuman, Argentina, T400IAK
Australia, New South Wales
St. Leonards, New South Wales, Australia, 2065
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
Australia
Sydney, New South Wales, Australia, 2077
Austria
Bludesch, Austria, 6712
Bregenz, Austria, 6900
Feldkirch, Austria, 6807
Graz, Austria, 8036
Innsbruck, Austria, 6020
Knittelfeld, Austria, 8720
Kufstein, Austria, 6330
Linz, Austria, 4010
Linz, Austria, 4020
Natters, Austria, 6161
Salzburg, Austria, 5020
St Veit An Der Glan, Austria, 9300
Vöcklabruck, Austria, 4840
Wels, Austria, 4600
Wien, Austria, 1030
Wien, Austria, 1090
Wien, Austria, 1130
Wien, Austria, 1140
Wien, Austria, 1145
Zams, Austria, 6511
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Salvador, Bahia, BA, Brazil, 40170-110
Fortaleza, CE, Brazil, 60430-230
Vitoria, ES, Brazil, 29055-270
Goiania, GO, Brazil, 74075-040
Belo Horizonte, MG, Brazil, 30110-090
Belo Horizonte, MG, Brazil, 30150-320
Recife, PE, Brazil, 52012-220
Rio De Janeiro, RJ, Brazil, 20520-100
Rio de Janeiro, RJ, Brazil, 22260-020
Rio de Janeiro, RJ, Brazil, 22631-004
Ijui, RS, Brazil, 98700-000
Porto Alegre, RS, Brazil, 90050-170
Porto Alegre, RS, Brazil, 90110-270
Porto Alegre, RS, Brazil, 90430-090
Porto Alegre, RS, Brazil, 90610-000
Campinas, SP, Brazil, 13059-900
Campinas, SP, Brazil, 13073-400
Jau, SP, Brazil, 17210-120
Ribeirao Preto, SP, Brazil, 14025-270
Santos, SP, Brazil, 11075-350
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 01308-505
Sao Paulo, SP, Brazil, 01323-020
Sao Paulo, SP, Brazil, 01323-903
Sao Paulo, SP, Brazil, 01509-900
Sao Paulo, SP, Brazil, 05401-400
Sao Paulo, SP, Brazil, 08270-070
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H3A 1A1
China
Beijing, China, 100021
Beijing, China, 100730
Beijing, China, 101149
Guangzhou, China, 510060
Guangzhou, China, 510080
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, 3623
Quito, Ecuador, 17114965
Egypt
Cairo, Egypt, 11737
Cairo, Egypt, 11796
Estonia
Tallinn, Estonia, 11619
Tartu, Estonia, 51003
Finland
Helsinki, Finland, 00290
Paimio, Finland, 21540
Pori, Finland, 28500
Tampere, Finland, 33520
France
Aix En Provence, France, 13616
Avignon, France, 84000
Besancon, France, 75015
Beziers, France, 34525
Bordeaux, France, 33076
Brest, France, 29200
Caen, France, 14076
Chalon Sur Saone, France, 71100
Clermont-ferrand, France, 63003
GAP, France, 5000
Grenoble, France, 38100
Le Chesnay, France, 33300
Lille, France, 59020
Lille, France, 59037
Lille, France, 59042
Lyon, France, 69004
Marseille, France, 13008
Marseille, France, 13273
Marseille, France, 13274
Meaux, France, 77104
Nancy, France, 54100
Neuilly Sur Seine, France, 92200
Paris, France, 75248
Paris, France, 75571
Perpignan, France, 66000
Reims, France, 51100
St Julien En Genevois, France, 74160
Strasbourg, France, 67085
Strasbourg, France, 69091
Toulon, France, 83000
Toulon, France, 83056
Toulouse, France, 31052
Toulouse, France, 31400
Valenciennes, France, 59300
Vandoeuvre Les Nancy, France, 54511
Germany
Augsburg, Germany, 86150
Bad Berka, Germany, 99437
Bayreuth, Germany, 95455
Berlin, Germany, 12167
Berlin, Germany, 12200
Berlin, Germany, 13353
Bielefeld, Germany, 33604
Bonn, Germany, 53113
Coswig, Germany, 01640
Donaustauf, Germany, 93093
Düsseldorf, Germany, 40225
Ebensfeld, Germany, 96250
Erlangen, Germany, 91054
Essen, Germany, 45147
Frankfurt, Germany, 60488
Freiburg, Germany, 79106
Gauting, Germany, 82131
Gerlingen, Germany, 70839
Grosshansdorf, Germany, 22927
Göttingen, Germany, 37075
Halle (Saale), Germany, 06120
Hamburg, Germany, 21075
Hamburg, Germany, 22081
Hannover, Germany, 30169
Hannover, Germany, 30625
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
Minden, Germany, 32423
Muenchen, Germany, 80336
Neuruppin, Germany, 16816
Nürnberg, Germany, 90419
Oldenburg, Germany, 26121
Rostock, Germany, 18057
Treuenbrietzen, Germany, 14929
Ulm, Germany, 89081
Villingen-Schwenningen, Germany, 78045
Wiesbaden, Germany, 65199
Wolfsburg, Germany, 38440
Wuerselen, Germany, 52146
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Shatin, Hong Kong
Hungary
Budapest, Hungary, 1529
Mátraháza, Hungary, 3233
Pecs, Hungary, 7635
Szombathely, Hungary, 9700
Torokbalint, Hungary, 2045
Iceland
Reykjavik, Iceland, 101
Israel
Beer Sheva, Israel, 84101
Haifa, Israel, 31096
Jerusalem, Israel, 12000
Jerusalem, Israel, 91031
Kfar-Saba, Israel, 44281
Ramat Gan, Israel, 52621
Tel Aviv, Israel, 64239
Zerifin, Israel, 70300
Italy
Avezzano, Abruzzo, Italy, 67051
Pescara, Abruzzo, Italy, 65100
Potenza, Basilicata, Italy, 85100
Rionero in Vulture, Basilicata, Italy, 85029
Catanzaro, Calabria, Italy, 88100
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Carpi, Emilia-Romagna, Italy, 41012
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, 00100
Roma, Lazio, Italy, 00144
Roma, Lazio, Italy, 00161
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
Cremona, Lombardia, Italy, 26100
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20162
Pavia, Lombardia, Italy, 27100
S Fermo Della Battaglia, Lombardia, Italy, 22100
Sondrio, Lombardia, Italy, 23100
Ancona, Marche, Italy
Novara, Piemonte, Italy, 28100
Bari, Puglia, Italy, 70126
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
Palermo, Sicilia, Italy, 90127
Taormina, Sicilia, Italy, 98039
Arezzo, Toscana, Italy, 52100
Lido Di Camaiore, Toscana, Italy, 55043
Pisa, Toscana, Italy, 56100
Camposampiero, Veneto, Italy, 35012
Feltre - Bl, Veneto, Italy, 32032
Negrar, Veneto, Italy, 37024
Bologna, Umbria, Italy, 6132
Forli, Emilia-Romagna, Italy, 47100
Latvia
Riga, Latvia, LV 1079
Riga, Latvia, LV-1002
Lebanon
Beirut, Lebanon, 99999
Lithuania
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 5808
Vilnius, Lithuania, 08660
Mexico
Chihuahua, Mexico, 31000
Leon, Mexico, 37150
Mexico City, Mexico, 14080
Mexico City, Mexico, 16200
Netherlands
Arnhem, Netherlands, 6815 AD
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
Nieuwegein, Netherlands, 3430 CM
Schiedam, Netherlands, 3116 BA
Tiel, Netherlands, 4002 WP
Zwolle, Netherlands, 8011 JW
Poland
Bialystok, Poland, 15-540
Krakow, Poland, 31-115
Lublin, Poland, 20-950
Poznan, Poland, 60-569
Warszawa, Poland, 02-781
Warszawa, Poland, 04-394
Zabrze, Poland, 41-483
Portugal
Braga, Portugal, 4719
Coimbra, Portugal, 55643
Lisboa, Portugal, 1070
Lisboa, Portugal, 1600
Lisboa, Portugal, 17769-001
Porto, Portugal, 4200-072
Porto, Portugal, 4200
Santa Maria Da Feira, Portugal, 4520-211
Setubal, Portugal, 2910-446
Vila Nova De Gaia, Portugal, 4400-129
Romania
Bucharest, Romania, 010816
Cluj Napoca, Romania, 3400
Timisoara, Romania, 300223
Russian Federation
Balashikha, Russian Federation, 143900
Engels, Russian Federation, 413115
Irkutsk, Russian Federation, 664035
Kislino, Kursk Region, Russian Federation, 305035
Krasnodar, Russian Federation, 350086
Moscow, Russian Federation, 107005
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
Samara, Russian Federation, 443066
Smolensk, Russian Federation, 214000
Stavropol, Russian Federation, 355047
Tumen, Russian Federation, 625047
Tver, Russian Federation, 170008
Ulyanovsk, Russian Federation, ND
Serbia
Belgrade, Serbia, 11000
Slovakia
Bratislava, Slovakia, 825 56
Kosice, Slovakia, 041 90
Nitra, Slovakia, 949 88
Poprad, Slovakia, 058 87
Slovenia
Golnik, Slovenia, 4204
Ljubljana, Slovenia, 1000
Spain
Elche, Alicante, Spain, 03202
Manresa, Barcelona, Spain, 08243
Mataro, Barcelona, Spain, 08304
Sabadell, Barcelona, Spain, 08208
Terrassa, Barcelona, Spain, 08221
Santander, Cantabria, Spain, 39008
Palma De Mallorca, Islas Baleares, Spain, 07014
Alcorcon, Madrid, Spain, 28922
Pamplona, Navarra, Spain, 31008
La Laguna, Tenerife, Spain, 38320
Barakaldo, Vizcaya, Spain, 48903
Alicante, Spain, 3010
Barcelona, Spain, 08025
Barcelona, Spain, 08907
Barcelona, Spain, 08916
Girona, Spain, 17007
Huesca, Spain, 22004
La Coruña, Spain, 15006
Lugo, Spain, 27004
Madrid, Spain, 28002
Madrid, Spain, 28034
Madrid, Spain, 28035
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Murcia, Spain, 30008
Salamanca, Spain, 37007
Valencia, Spain, 41014
Valencia, Spain, 46009
Valencia, Spain, 46010
Valencia, Spain, 46015
Zaragoza, Spain, 50009
Sweden
Gothenburg, Sweden, 41345
Lund, Sweden, 22185
Malmoe, Sweden, 20502
Oerebro, Sweden, 70185
Stokholm, Solna, Sweden, 01716
Umea, Sweden, 90185
Uppsala, Sweden, 751 85
Switzerland
Aarau, Switzerland, 5000
Baden, Switzerland, 5404
Genolier, Switzerland, 1272
Locarno, Switzerland, 6601
Taiwan
Taichung, Taiwan, 407
Tainan, Taiwan, 704
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
Turkey
Ankara, Turkey, 06530
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34300
Istanbul, Turkey, 34383
Izmir, Turkey, 35100
Sıhhiye, ANKARA, Turkey, 06100
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Belfast, United Kingdom, BT9 7AB
Birmingham, United Kingdom, B9 5SS
Cambridge, United Kingdom, PE3 6DA
Cardiff, United Kingdom, CF14 2TL
Manchester, United Kingdom, M23 9LT
Nottingham, United Kingdom, NG5 1PB
Suffolk, United Kingdom, IP33 2QZ
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

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
Results First Received: March 23, 2016
Last Updated: April 25, 2016
Health Authority: Austria: Ministry of Health

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

ClinicalTrials.gov processed this record on August 23, 2016