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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | 80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Event driven |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response. | Event driven | |
| Safety:AEs, laboratory tests, SAEs, coagulation parameters | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahía Blanca | 8000 | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21245868 | Derived | 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. | |
| 20978447 | Derived | 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. |
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| Gemcitabine | Drug | 1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles |
|
| Placebo | Drug | iv on day 1 of each 3 week cycle until disease progression |
|
| bevacizumab [Avastin] | Drug | 15mg/kg 1v on day 1 of each 3 week cycle until disease progression |
|
| bevacizumab [Avastin] | Drug | 7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression |
|
| Buenos Aires |
| C1270AAE |
| Argentina |
| Buenos Aires | C1426ANZ | Argentina |
| Mendoza | 5500 | Argentina |
| San Miguel de Tucumán | 4000 | Argentina |
| Santa Fe | 03000 | Argentina |
| Santa Fe | 2000 | Argentina |
| Adelaide | 5011 | Australia |
| Adelaide | 5065 | Australia |
| Brisbane | 4029 | Australia |
| Canberra | 2606 | Australia |
| Kurralta Park | 5037 | Australia |
| Melbourne | 3128 | Australia |
| Parkville | 3052 | Australia |
| Perth | 6009 | Australia |
| Sydney | 2050 | Australia |
| Sydney | 2139 | Australia |
| Tugun | 4224 | Australia |
| Wollongong | 2500 | Australia |
| Brussels | 1200 | Belgium |
| Haine-Saint-Paul | 7100 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Belo Horizonte | 30150321 | Brazil |
| Porto Alegre | 90020-090 | Brazil |
| Rio de Janeiro | 20231-050 | Brazil |
| São Paulo | 01221-020 | Brazil |
| Plovdiv | 4004 | Bulgaria |
| Sofia | 1527 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Stara Zagora | 8000 | Bulgaria |
| Varna | 9002 | Bulgaria |
| Veliko Tarnovo | 5000 | Bulgaria |
| Calgary | Alberta | T2N 4N2 | Canada |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| Victoria | British Columbia | V8R 6V5 | Canada |
| Moncton | New Brunswick | E1C 8X3 | Canada |
| London | Ontario | N6A 4L6 | Canada |
| Mississauga | Ontario | L5M 2N1 | Canada |
| Newmarket | Ontario | L3Y 2P9 | Canada |
| Toronto | Ontario | M5G 1X5 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Toronto | Ontario | M9N 1N8 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Montreal | Quebec | H2W 1S6 | Canada |
| Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Ostrava | 703 84 | Czechia |
| Ostrava | 708 52 | Czechia |
| Prague | 180 01 | Czechia |
| Ústí nad Labem | 401 13 | Czechia |
| Belfort | 90016 | France |
| Bobigny | 93009 | France |
| Caen | 14076 | France |
| Lyon | 69004 | France |
| Marseille | 13273 | France |
| Montbéliard | 25209 | France |
| Montpellier | 34295 | France |
| Pierre-Bénite | 69495 | France |
| Rennes | 35033 | France |
| Rouen | 76000 | France |
| Saint-Herblain | 44805 | France |
| Strasbourg | 67091 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 14165 | Germany |
| Essen | 45122 | Germany |
| Gauting | 82131 | Germany |
| Göttingen | 37075 | Germany |
| Hamburg | 20246 | Germany |
| Hamburg | 21075 | Germany |
| Hamburg | 22045 | Germany |
| Heidelberg | 69126 | Germany |
| Hemer | 58675 | Germany |
| Karlsruhe | 76137 | Germany |
| Leverkusen | 51375 | Germany |
| Mainz | 55131 | Germany |
| Mannheim | 68167 | Germany |
| München | 80336 | Germany |
| Alexandroupoli | 68100 | Greece |
| Athens | 11522 | Greece |
| Athens | 11527 | Greece |
| Thessaloniki | 57010 | Greece |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Budapest | 1529 | Hungary |
| Mosdós | 7257 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Székesfehérvár | 8001 | Hungary |
| Szombathely | 9700 | Hungary |
| Zalaegerszeg | 8901 | Hungary |
| Jerusalem | 91120 | Israel |
| Kfar Saba | 44281 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 52621 | Israel |
| Tel Aviv | 6423906 | Israel |
| Candiolo | 10060 | Italy |
| Catania | 95123 | Italy |
| Genova | 16132 | Italy |
| Milan | 20133 | Italy |
| Milan | 20162 | Italy |
| Naples | 80131 | Italy |
| Parma | 43100 | Italy |
| Perugia | 06132 | Italy |
| Reggio Emilia | 42100 | Italy |
| Roma | 00152 | Italy |
| Roma | 00168 | Italy |
| Rozzano | 20089 | Italy |
| Gdansk | 80-214 | Poland |
| Gdynia | 81-519 | Poland |
| Lublin | 20-950 | Poland |
| Olsztyn | 10-228 | Poland |
| Poznan | 60-569 | Poland |
| Szczecin | 70-891 | Poland |
| Warsaw | 02-781 | Poland |
| Balashikha | 143900 | Russia |
| Moscow | 105229 | Russia |
| Moscow | 107005 | Russia |
| Moscow | 115478 | Russia |
| Moscow | 123098 | Russia |
| Moscow | 143423 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saint Petersburg | 197758 | Russia |
| Saint Petersburg | 198255 | Russia |
| Alicante | 03010 | Spain |
| Barakaldo | 48903 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Barcelona | 08907 | Spain |
| Girona | 17007 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28041 | Spain |
| Madrid | 28046 | Spain |
| Madrid | 28222 | Spain |
| Málaga | 29010 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Seville | 41013 | Spain |
| Seville | 41014 | Spain |
| Valencia | 41014 | Spain |
| Valencia | 46009 | Spain |
| Valencia | 46010 | Spain |
| Valencia | 46015 | Spain |
| Kueishan | 333 | Taiwan |
| Taichung | 404 | Taiwan |
| Taichung | 407 | Taiwan |
| Taipei | 105 | Taiwan |
| Taipei | Taiwan |
| Bangkok | 10400 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Guildford | GU2 7XX | United Kingdom |
| London | N18 1QX | United Kingdom |
| Manchester | M2O 4BX | United Kingdom |
| Sheffield | S10 2SJ | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
| Yeovil | BA21 4AT | United Kingdom |
| 20150572 | Derived | 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. |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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