A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00806923
First received: December 10, 2008
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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 recu rrent non-squamous non-small cell lung cancer (NSCLC) who have not received prio r chemotherapy. The anticipated time of study treatment is until disease progres sion, and the target sample size is 500+ individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Cisplatin
Drug: Gemcitabine
Drug: Placebo
Drug: bevacizumab [Avastin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Safety:AEs, laboratory tests, SAEs, coagulation parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 1044
Study Start Date: February 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
Experimental: 2 Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
Placebo Comparator: 3 Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: Placebo
iv on day 1 of each 3 week cycle until disease progression

  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;
  • 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.
  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: NCT00806923

  Hide Study Locations
Locations
Argentina
Bahia Blanca, Argentina, 8000
Buenos Aires, Argentina, C1270AAE
Buenos Aires, Argentina, C1426ANZ
Mendoza, Argentina, 5500
San Miguel de Tucuman, Argentina, 4000
Santa Fe, Argentina, 2000
Santa Fe, Argentina, 03000
Australia
Adelaide, Australia, 5065
Adelaide, Australia, 5011
Brisbane, Australia, 4029
Canberra, Australia, 2606
Kurralta Park, Australia, 5037
Melbourne, Australia, 3128
Parkville, Australia, 3052
Perth, Australia, 6009
Sydney, Australia, 2139
Sydney, Australia, 2050
Tugun, Australia, 4224
Wollongong, Australia, 2500
Belgium
Bruxelles, Belgium, 1200
Haine-saint-paul, Belgium, 7100
Leuven, Belgium, 3000
Liege, Belgium, 4000
Brazil
Belo Horizonte, Brazil, 30150321
Porto Alegre, Brazil, 90020-090
Rio de Janeiro, Brazil, 20231-050
Sao Paulo, Brazil, 01221-020
Bulgaria
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1756
Sofia, Bulgaria, 1527
Stara Zagora, Bulgaria, 8000
Varna, Bulgaria, 9002
Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Victoria, British Columbia, Canada, V8R 6V5
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
London, Ontario, Canada, N6A 4L6
Mississauga, Ontario, Canada, L5M 2N1
Newmarket, Ontario, Canada, L3Y 2P9
Toronto, Ontario, Canada, M9N 1N8
Toronto, Ontario, Canada, M5G 1X5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Montreal, Quebec, Canada, H2L 4M1
Montréal, Quebec, Canada, H2W 1S6
Sainte-foy, Quebec, Canada, G1V 4G2
Czech Republic
Ostrava, Czech Republic, 708 52
Ostrava, Czech Republic, 703 84
Praha, Czech Republic, 180 01
Usti Nad Labem, Czech Republic, 401 13
France
Belfort, France, 90016
Bobigny, France, 93009
Caen, France, 14076
Lyon, France, 69004
Marseille, France, 13273
Montbeliard, France, 25209
Montpellier, France, 34295
Pierre Benite, France, 69495
Rennes, France, 35033
Rouen, France, 76000
St Herblain, France, 44805
Strasbourg, France, 67091
Vandoeuvre Les Nancy, France, 54511
Germany
Berlin, Germany, 14165
Essen, Germany, 45122
Gauting, Germany, 82131
Göttingen, Germany, 37075
Hamburg, Germany, 21075
Hamburg, Germany, 20246
Hamburg, Germany, 22045
Heidelberg, Germany, 69126
Hemer, Germany, 58675
Karlsruhe, Germany, 76137
Leverkusen, Germany, 51375
Mainz, Germany, 55131
Mannheim, Germany, 68167
München, Germany, 80336
Greece
Alexandroupolis, Greece, 68100
Athens, Greece, 11522
Athens, Greece, 11527
Thessaloniki, Greece, 57010
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Hungary
Budapest, Hungary, 1529
Mosdos, Hungary, 7257
Nyiregyhaza, Hungary, 4400
Szekesfehervar, Hungary, 8001
Szombathely, Hungary, 9700
Zalaegerszeg, Hungary, 8901
Israel
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 49100
Ramat-gan, Israel, 52621
Tel Aviv, Israel, 6423906
Italy
Candiolo, Italy, 10060
Catania, Italy, 95123
Genova, Italy, 16132
Milano, Italy, 20162
Milano, Italy, 20133
Napoli, Italy, 80131
Parma, Italy, 43100
Perugia, Italy, 06132
Reggio Emilia, Italy, 42100
Roma, Italy, 00168
Roma, Italy, 00152
Rozzano, Italy, 20089
Poland
Gdansk, Poland, 80-214
Gdynia, Poland, 81-519
Lublin, Poland, 20-950
Olsztyn, Poland, 10-228
Poznan, Poland, 60-569
Szczecin, Poland, 70-891
Warszawa, Poland, 02-781
Russian Federation
Balashikha, Russian Federation, 143900
Moscow, Russian Federation, 105229
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
Moscow, Russian Federation, 123098
Moscow, Russian Federation, 107005
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197758
St Petersburg, Russian Federation, 198255
Spain
Alicante, Spain, 03010
Barakaldo, Spain, 48903
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08907
Girona, Spain, 17007
La Laguna, Spain, 38320
Madrid, Spain, 28040
Madrid, Spain, 28046
Madrid, Spain, 28041
Madrid, Spain, 28222
Málaga, Spain, 29010
Sevilla, Spain, 41013
Sevilla, Spain, 41014
Valencia, Spain, 41014
Valencia, Spain, 46010
Valencia, Spain, 46009
Valencia, Spain, 46015
Taiwan
Kueishan, Taiwan, 333
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Taipei, Taiwan
Taipei, Taiwan, 105
Thailand
Bangkok, Thailand, 10400
Chiang Mai, Thailand, 50200
United Kingdom
Guildford, United Kingdom, GU2 7XX
London, United Kingdom, N18 1QX
Manchester, United Kingdom, M2O 4BX
Sheffield, United Kingdom, S10 2SJ
Sutton, United Kingdom, SM2 5PT
Yeovil, United Kingdom, BA21 4AT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: 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: NCT00806923     History of Changes
Other Study ID Numbers: BO17704
Study First Received: December 10, 2008
Last Updated: October 20, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Cisplatin
Gemcitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014