Clinical trial NCT00300885: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Non-Small Cell Lung Cancer
NSCLC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-03-10
Enrollment: 926
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Stage IIIB (with effusion) or Stage IV NSCLC any histology
* 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:

* Prior systemic anti cancer therapy
* 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

Primary outcomes:
measure: Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo
timeFrame: Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
measure: Overall Best Response
timeFrame: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
measure: Duration of Response
timeFrame: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
measure: Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)
timeFrame: Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis
measure: Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)
timeFrame: Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Burbank
country: United States
state: California
city: Corona
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Highland
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Lakeland
country: United States
state: Florida
city: Merritt Island
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Savannah
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state: Georgia
city: Chicago
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state: Illinois
city: Skokie
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
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city: Kokomo
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state: Iowa
city: Hutchinson
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state: Kansas
city: Wichita
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city: Louisville
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state: Kentucky
city: Baton Rouge
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state: Louisiana
city: Metairie
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state: Louisiana
city: Boston
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state: Massachusetts
city: Pittsfield
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state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
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city: Hattiesburg
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state: Mississippi
city: Jefferson City
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state: Missouri
city: Kansas City
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state: Missouri
city: Lincoln
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state: Nebraska
city: Las Vegas
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state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Hackensack
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: New York
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state: New York
city: Rochester
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state: New York
city: Staten Island
country: United States
state: New York
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Columbus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
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city: Dover
country: United States
state: Ohio
city: Oklahoma City
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state: Oklahoma
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state: Oklahoma
city: Portland
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state: Oregon
city: Allentown
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state: Pennsylvania
city: Bethlehem
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Pottsville
country: United States
state: Pennsylvania
city: Sayre
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state: Pennsylvania
city: Charleston
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state: South Carolina
city: Greenville
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state: South Carolina
city: Knoxville
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state: Tennessee
city: Nashville
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state: Tennessee
city: Trophy Club
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state: Texas
city: Salt Lake City
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state: Utah
city: Abingdon
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state: Virginia
city: Fairfax
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state: Virginia
city: Richlands
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city: Richmond
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state: Virginia
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state: West Virginia
city: Milwaukee
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state: Wisconsin
city: El Palomar - Morón
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: Mar del Plata
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: Capital Federal-Buenos Aires
country: Argentina
city: Santa Fé
country: Argentina
city: Port Macquarie
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Frankston
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Bruxelles - Brussel
country: Belgium
city: Charleroi
country: Belgium
city: La Louviere
country: Belgium
city: Liege
country: Belgium
city: Salvador
country: Brazil
state: Bahia
city: Fortaleza
country: Brazil
state: Ceará
city: Fortaleza
country: Brazil
state: Ceará
city: Brasília
country: Brazil
state: Distrito Federal
city: Goiânia
country: Brazil
state: Goiás
city: Nova Lima
country: Brazil
state: Minas Gerais
city: Curitiba
country: Brazil
state: Parana
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Joinville
country: Brazil
state: Santa Catarina
city: Barretos
country: Brazil
state: Sao Paulo
city: Jaú
country: Brazil
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
state: Sao Paulo
city: Santo Andre
country: Brazil
state: Sao Paulo
city: Sorocaba
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: Belo Horizonte
country: Brazil
city: North Vancouver
country: Canada
state: British Columbia
city: Barrie
country: Canada
state: Ontario
city: Brampton
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Bobigny Cedex
country: France
city: Caen
country: France
city: Clamart
country: France
city: Metz
country: France
city: Nancy
country: France
city: Nice Cedex 2
country: France
city: Strasbourg
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Gauting
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Hofheim
country: Germany
state: Hessen
city: Göttingen
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Oldenburg
country: Germany
state: Niedersachsen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Hemer
country: Germany
state: Nordrhein-Westfalen
city: Leverkusen
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Großhansdorf
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Deszk
country: Hungary
city: Gyula
country: Hungary
city: Matrahaza
country: Hungary
city: Torokbalint
country: Hungary
city: Orbassano
country: Italy
state: Torino
city: Bergamo
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Parma
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Eindhoven
country: Netherlands
state: Noord-Brabant
city: Zwolle
country: Netherlands
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Olsztyn
country: Poland
city: Otwock
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: San Juan
country: Puerto Rico
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Elche
country: Spain
state: Alicante
city: Zaragoza
country: Spain
state: Aragón
city: Majadahonda
country: Spain
state: Madrid
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Pontevedra
country: Spain
city: Zamora
country: Spain
city: Gävle
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Plymouth
country: United Kingdom
state: Devon
city: Bornemouth
country: United Kingdom
state: Dorset
city: Leicester
country: United Kingdom
state: Leicestershire
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.