A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00300885
Last Updated: 2014-11-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
926 participants
INTERVENTIONAL
2006-02-28
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sorafenib + C/P
Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel
Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
Placebo + C/P
Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
Carboplatin plus Paclitaxel
Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
Interventions
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Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel
Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
Carboplatin plus Paclitaxel
Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Greater than or equal to 18 years of age
* Life expectancy at least 12 weeks
* Adequate bone marrow, liver and renal function
Exclusion Criteria
* Known brain metastasis. Patients with neurological symptoms should undergo at computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis
* Pulmonary hemorrhage/bleeding event \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug
* Thrombotic or embolic events including Transient ischemic attack (TIA) within the past 6 months
* Uncontrolled hypertension
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Major surgery within 4 weeks
* Evidence or history of bleeding diathesis or coagulopathy
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Springdale, Arkansas, United States
Anaheim, California, United States
Beverly Hills, California, United States
Burbank, California, United States
Corona, California, United States
Encinitas, California, United States
Highland, California, United States
Los Angeles, California, United States
Orange, California, United States
Sacramento, California, United States
Denver, Colorado, United States
Lakeland, Florida, United States
Merritt Island, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Skokie, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Kokomo, Indiana, United States
Sioux City, Iowa, United States
Hutchinson, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
Boston, Massachusetts, United States
Pittsfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Hattiesburg, Mississippi, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Dover, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pottsville, Pennsylvania, United States
Sayre, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Trophy Club, Texas, United States
Salt Lake City, Utah, United States
Abingdon, Virginia, United States
Fairfax, Virginia, United States
Richlands, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
El Palomar - Morón, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Capital Federal-Buenos Aires, , Argentina
Santa Fé, , Argentina
Port Macquarie, New South Wales, Australia
Wollongong, New South Wales, Australia
Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Bruxelles - Brussel, , Belgium
Charleroi, , Belgium
La Louvière, , Belgium
Liège, , Belgium
Fortaleza, Ceará, Brazil
Fortaleza, Ceará, Brazil
Salvador, Estado de Bahia, Brazil
Brasília, Federal District, Brazil
Goiânia, Goiás, Brazil
Nova Lima, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Joinville, Santa Catarina, Brazil
Barretos, São Paulo, Brazil
Jaú, São Paulo, Brazil
Ribeirão Preto, São Paulo, Brazil
Santo André, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Belo Horizonte, , Brazil
North Vancouver, British Columbia, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Montreal, Quebec, Canada
Regina, Saskatchewan, Canada
Santiago, Santiago Metropolitan, Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Bobigny, , France
Caen, , France
Clamart, , France
Metz, , France
Nancy, , France
Nice, , France
Strasbourg, , France
Heidelberg, Baden-Wurttemberg, Germany
Mannheim, Baden-Wurttemberg, Germany
Gauting, Bavaria, Germany
München, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Hofheim, Hesse, Germany
Göttingen, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Oldenburg, Lower Saxony, Germany
Essen, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Hemer, North Rhine-Westphalia, Germany
Leverkusen, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Großhansdorf, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Hong Kong, , Hong Kong
Budapest, , Hungary
Deszk, , Hungary
Gyula, , Hungary
Mátraháza, , Hungary
Törökbálint, , Hungary
Orbassano, Torino, Italy
Bergamo, , Italy
Genova, , Italy
Milan, , Italy
Parma, , Italy
Pavia, , Italy
Perugia, , Italy
Roma, , Italy
Torino, , Italy
Eindhoven, North Brabant, Netherlands
Zwolle, , Netherlands
Gdansk, , Poland
Krakow, , Poland
Olsztyn, , Poland
Otwock, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Alicante, Alicante, Spain
Elche, Alicante, Spain
Zaragoza, Aragon, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Majadahonda, Madrid, Spain
Pontevedra, Pontevedra, Spain
Zamora, Zamora, Spain
Gävle, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Taichung, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Plymouth, Devon, United Kingdom
Bornemouth, Dorset, United Kingdom
Leicester, Leicestershire, United Kingdom
London, London, United Kingdom
Manchester, Manchester, United Kingdom
Countries
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References
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Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.
Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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2005-005245-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11961
Identifier Type: -
Identifier Source: org_study_id
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