stop_circleTerminated/Withdrawn

Carcinoma, Non-Small Cell Lung

Bayer Identifier:

11961

ClinicalTrials.gov Identifier:

NCT00300885

EudraCT Number:

2005-005245-19

EU CT Number:

Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
926
Trial Dates
February 2006 - February 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Lungenklinik HemerHemer, 58675, Germany
Completed
Klinikum Innenstadt der Ludwigs-Maximilians-UniversitätMünchen, 80336, Germany
Completed
Klinikum Mannheim gGmbHMannheim, 68167, Germany
Completed
Asklepios Fachkliniken München GautingGauting, 82131, Germany
Completed
Krankenhaus GrosshansdorfGroßhansdorf, 22927, Germany
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Completed
Universitätsmedizin der Georg-August-Universität GöttingenGöttingen, 37075, Germany
Terminated
Pius-Hospital OldenburgOldenburg, 26121, Germany
Terminated
Guy's HospitalLondon, SE1 9RT, United Kingdom
Terminated
Guy's HospitalLondon, SE1 9RT, United Kingdom
Completed
Berkshire Hematology/Oncology, PCPittsfield, 01201, United States
Terminated
Gabrail Cancer CenterDover, 44622, United States
Completed
Asklepios Klinik HarburgHamburg, 21075, Germany
Completed
Klinikum Leverkusen gGmbHLeverkusen, 51375, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Kliniken Essen - MitteEssen, 45136, Germany
Completed
Thoraxklinik-Heidelberg gGmbHHeidelberg, 69126, Germany
Completed
Krankenhaus Hofheim am TaunusHofheim, 65719, Germany
Completed
Royal Bournemouth General HospitalBornemouth, BH7 7DW, United Kingdom
Completed
Derriford HospitalPlymouth, PL6 8DH, United Kingdom
Completed
Wythenshawe HospitalManchester, M23 9LT, United Kingdom
Completed
Leicester Royal InfirmaryLeicester, LE1 5WW, United Kingdom
Terminated
Guy's HospitalLondon, SE1 9RT, United Kingdom
Terminated
Guy's HospitalLondon, SE1 9RT, United Kingdom
Terminated
Medical Oncology Care AssociatesOrange, 92868, United States
Terminated
Morgantown Internal Medicine Group, Inc.Morgantown, 26505, United States
Completed
Clintell, Inc.Skokie, 60077, United States
Completed
Capital Comprehensive Cancer Care ClinicJefferson City, 65109, United States
Completed
Hattiesburg ClinicHattiesburg, 39401, United States
Completed
Cancer Outreach AssociatesAbingdon, 24211, United States
Terminated
Hematology/Oncology of IndianaIndianapolis, 46260, United States
Terminated
Pacific Oncology/Hematology AssociatesEncinitas, 92024, United States
Terminated
Mount Sinai Medical CenterNew York, 10029, United States
Completed
Siouxland Hematology/Oncology Associates, LLPSioux City, 51101, United States
Terminated
Sanford Roger Maris Cancer CenterFargo, 58122, United States
Completed
Cancer Care AssociatesTulsa, 74136, United States
Completed
Highlands Oncology GroupSpringdale, 72764, United States
Completed
St. John's Mercy Medical CenterSt. Louis, 63141, United States
Completed
Hematology & Oncology Consultants, PAOrlando, 32804, United States
Completed
Watson Clinic Center for ResearchLakeland, 33805, United States
Completed
Tenessee Cancer SpecialistsKnoxville, 37920, United States
Completed
Jayne Gurtler APMCMetairie, 70006, United States
Completed
Simon-Williamson Clinic, PCBirmingham, 35211, United States
Completed
Fairfax-Northern Virginia Hematology/Oncology, PCFairfax, 22031, United States
Completed
St. Joseph Mercy HospitalAnn Arbor, 48106, United States
Completed
Peachtree Hematology & Oncology Consultants, PCAtlanta, 30309, United States
Terminated
Lehigh Valley Hospital - Cedar CrestAllentown, 18103, United States
Completed
Oklahoma University Health Science CenterOklahoma City, 73104, United States
Completed
Hematology/Oncology ClinicBaton Rouge, 70808, United States
Terminated
Las Vegas Cancer CenterLas Vegas, 89102, United States
Completed
University of Utah Medical CenterSalt Lake City, 84112, United States
Completed
Cancer Centers of the CarolinasGreenville, 29615, United States
Completed
Virginia Oncology Care, PCRichlands, 24641, United States
Completed
Arkansas Oncology AssociatesLittle Rock, 72205, United States
Completed
Kentuckiana Cancer Institute, PLLCLouisville, 40215, United States
Terminated
Providence Portland Medical CenterPortland, 97213, United States
Completed
Arlington Cancer CenterTrophy Club, 76262, United States
Completed
Hackensack University Medical CenterHackensack, 07601, United States
Terminated
Hematology/Oncology Associates of Northern New Jersey, PAMorristown, 07962-1089, United States
Completed
Office of Dr. William Tester, MDPhiladelphia, 19115, United States
Completed
Hematology & Oncology of Dayton, Inc.Dayton, 45429, United States
Terminated
Staten Island University HospitalStaten Island, 10305, United States
Completed
East Valley Hematology/Oncology Medical GroupBurbank, 91595, United States
Terminated
Odyssey Research ServicesBismarck, 58501, United States
Completed
Henry Ford Health SystemDetroit, 48202, United States
Completed
Oncology-Hematology of Lehigh Valley, PCBethlehem, 18015, United States
Completed
Sacred Heart Medical Oncology GroupMobile, 36608, United States
Completed
Metropolitan Hematology Oncology Medical GroupLos Angeles, 90057, United States
Completed
University of ChicagoChicago, 60637, United States
Terminated
Kansas City Cancer Centers, LLCKansas City, 64111, United States
Completed
Rocky Mountain Cancer CentersDenver, 80218, United States
Terminated
Howard Regional Health System-Main CampusKokomo, 46902, United States
Completed
Compassionate Cancer Care Medical Group, Inc.Corona, 92829, United States
Terminated
Southeast Nebraska Cancer CenterLincoln, 68510, United States
Completed
Northwest Georgia Oncology Centers, PCMarietta, 30060, United States
Completed
Indiana UniversityIndianapolis, 46202, United States
Completed
Candler Hospital/St. Joseph's Candler Health SystemSavannah, 31405, United States
Completed
Fort Wayne Medical Hematology & OncologyFort Wayne, 46815, United States
Completed
Centre François Baclesse - CLCC - CaenCAEN, 14073, France
Completed
ZOZ MSWiA z Warminsko-Mazurskim Centrum OnkologiiOlsztyn, 10-228, Poland
Completed
Uniwersyteckie Centrum KliniczneGdansk, 80-952, Poland
Completed
Centrum Onkologii Instytut im. M. Sklodowskiej-CurieKrakow, 31-115, Poland
Completed
Dolnoslaskie Centrum Chorób PlucWroclaw, 53-439, Poland
Completed
A.O.U. San Luigi GonzagaOrbassano, 10043, Italy
Completed
A.O. Città della Salute e della Scienza di TorinoTorino, 10126, Italy
Completed
A.O. di PerugiaPerugia, 06156, Italy
Completed
IRCCS Ist Nazionale Tumori GEGenova, 16132, Italy
Completed
A.O. San Camillo-ForlaniniRoma, 00152, Italy
Completed
A.O.U. di ParmaParma, 43100, Italy
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
Hospital General de ElcheElche, 03202, Spain
Terminated
Hospital General Universitario de AlicanteAlicante, 03010, Spain
Completed
Hospital Universitario Clinica Puerta de HierroMajadahonda, 28222, Spain
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Allan Blair Cancer CentreRegina, S4T 7T1, Canada
Terminated
Allan Blair Cancer CentreRegina, S4T 7T1, Canada
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 171 76, Sweden
Completed
Länssjukhuset Gävle-SandvikenGävle, 801 87, Sweden
Completed
Port Macquarie Base HospitalPort Macquarie, 2444, Australia
Completed
Southeast OncologyMelbourne, 3144, Australia
Completed
Royal Brisbane & Women's HospitalBrisbane, 4029, Australia
Completed
Southern Medical Day Care CentreWollongong, 2500, Australia
Completed
Instituto Médico PlatenseLa Plata, B1900AVG, Argentina
Completed
Centro Especializado ISISSanta Fé, S3000FFV, Argentina
Completed
Hospital Nacional Professor A. PosadasEl Palomar - Morón, 1684, Argentina
Terminated
Instituto C.A.I.C.I.Rosario, 2000, Argentina
Completed
Hospital Privado de la ComunidadMar del Plata, B7602CBM, Argentina
Completed
Centro de Cancer Nuestra Señora de la EsperanzaSantiago, Chile
Completed
Matrai State HospitalMatrahaza, 3233, Hungary
Completed
Pest County Lung InstituteTorokbalint, 2045, Hungary
Completed
Hospital IGESPSão Paulo, 01331010, Brazil
Completed
Fundação Pio XII – Hospital de Câncer de BarretosBarretos, 14784400, Brazil
Completed
Irmandade da Santa Casa de Misericordia - Sao PauloSão Paulo, Brazil
Completed
Biocor Hospital de Doenzas Cardiovasculares LtdaNova Lima, 34000000, Brazil
Completed
Instituto do Cancer do CearáFortaleza, 60430-230, Brazil
Completed
Hospital Sao Lucas da Pontificia Universidade Catolica do RSPorto Alegre, 90619900, Brazil
Completed
Centro de Oncologia do ParanáCuritiba, 80730-180, Brazil
Terminated
CEON - Centro especializado de OncologiaRibeirao Preto, 14015-140, Brazil
Completed
Hospital LuxemburgoBelo Horizonte, 30380490, Brazil
Completed
Hospital Nossa Senhora da ConceicaoPorto Alegre, 91350-200, Brazil
Completed
City Clinical Oncology CenterSt. Petersburg, 198255, Russia
Completed
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russia
Terminated
Moscow City Oncological Hospital No62Moscow, 143423, Russia
Terminated
Asan Medical CenterSeoul, 138736, Korea, Republic Of
Completed
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Completed
Chang-Guang Memorial HospitalTaoyuan, 333, Taiwan
Completed
Queen Elizabeth HospitalHong Kong, Hong Kong
Completed
EPIC Management, LPHighland, 92346, United States
Completed
Tower Hematology/Oncology Medical GroupBeverly Hills, 90211-1850, United States
Completed
Investigative Clinical Research of Indiana, LLCIndianapolis, 46254, United States
Completed
Virginia Commonwealth UniversityRichmond, 23298-0037, United States
Completed
MD Anderson Cancer Center-OrlandoOrlando, 32806, United States
Completed
Virginia Cancer InstituteRichmond, 23230, United States
Terminated
Vanderbilt University Medical SchoolNashville, 37232-6307, United States
Terminated
MD Anderson Cancer Center-OrlandoOrlando, 32806, United States
Terminated
North Shore Cancer Research AssociationSkokie, 60076, United States
Completed
Charleston Hematology & Oncology Associates, PACharleston, 29403, United States
Terminated
University of Rochester Medical CenterRochester, 14622, United States
Completed
Kansas City Cancer Centers, LLCKansas City, 64131, United States
Completed
Hematology Oncology Consultants, Inc.Columbus, 43235, United States
Terminated
Mid-Ohio Oncololgy/HematologyColumbus, 43213, United States
Terminated
Arizona Clinical Research CenterTucson, 85715, United States
Terminated
Mount Sinai Medical CenterNew York, 10029, United States
Terminated
Hutchinson ClinicHutchinson, 67502, United States
Terminated
Pottsville Cancer CenterPottsville, 17901, United States
Completed
Space Coast Medical AssociatesMerritt Island, 32952, United States
Terminated
VA Boston Healthcare System-Jamaica Plain DivisionBoston, 02130, United States
Terminated
Southern Nevada Cancer Research FoundationLas Vegas, 89106, United States
Terminated
Pacific Cancer Medical CenterAnaheim, 92801, United States
Terminated
San Juan VA Medical CenterSan Juan, 00921, United States
Terminated
Cancer Center of KansasWichita, 67214, United States
Terminated
Medical Consultants, Ltd.Milwaukee, 53215, United States
Completed
Guthrie ClinicSayre, 18840, United States
Terminated
University of California - DavisSacramento, 95817, United States
Completed
Hopital Avicenne - BobignyBOBIGNY CEDEX, 93009, France
Completed
Centre d'Oncologie de Gentilly - NancyNANCY, 54100, France
Terminated
Hopital Percy - ClamartCLAMART, 92140, France
Completed
Centre Antoine Lacassagne - NiceNICE CEDEX 2, 06102, France
Terminated
Hôpital Bon Secours - MetzMETZ, 57000, France
Completed
Hopital Lyautey - StrasbourgSTRASBOURG, 67100, France
Completed
Centrum Onkologii - Instytut im. M.Sklodowskiej-CurieWarszawa, 02-781, Poland
Completed
Wojskowy Instytut MedycznyWarszawa, 04-141, Poland
Terminated
Mazowieckie Centrum Leczenia Ch. Pluc i GruzlicyOtwock, 05-400, Poland
Terminated
A.O.U. di ParmaParma, 43100, Italy
Completed
A.O. Osp Niguarda Ca' GrandaMilano, 20162, Italy
Completed
A.O. Ospedali Riuniti BergamoBergamo, 24128, Italy
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Hospital Ruber InternacionalMadrid, 28034, Spain
Terminated
Complejo Hospitalario de PontevedraPontevedra, 36001, Spain
Completed
Complejo Hospitalario de ZamoraZamora, 49021, Spain
Terminated
Hospital Clínico Universitario Lozano BlesaZaragoza, 50009, Spain
Terminated
Hospital Universitario de la PrincesaMadrid, 28006, Spain
Completed
Office of Dr. Sandeep Sehdev, MDBrampton, L6W 3X4, Canada
Completed
University of British ColumbiaNorth Vancouver, V7L 2L7, Canada
Completed
Royal Victoria HospitalBarrie, L4M 6M2, Canada
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Grand Hôpital de CharleroiCHARLEROI, 6000, Belgium
Completed
CHU de LiègeLIEGE, 4000, Belgium
Terminated
CH de Jolimont - Lobbes Site de JolimontLA LOUVIERE, 7100, Belgium
Completed
Isala Klinieken, lokatie WeezenlandenZwolle, 8011 JW, Netherlands
Completed
CatharinaEINDHOVEN, 5623 EJ, Netherlands
Completed
Akademiska SjukhusetUppsala, 751 85, Sweden
Terminated
Perth OncologyPerth, 6000, Australia
Terminated
Burnside War Memorial HospitalAdelaide, 5065, Australia
Completed
Peninsula Oncology CentreFrankston, 3199, Australia
Completed
Hospital General de Agudos Dr. Carlos G. DurandBuenos Aires, C1405DCS, Argentina
Completed
Instituto Medico Especializado Alexander FlemingCapital Federal-Buenos Aires, C1426ANZ, Argentina
Completed
Instituto Nacional del CancerSantiago, 838-0455, Chile
Completed
Hospital Clínico San Borja ArriaránSantiago, 836-0156, Chile
Completed
Hospital DIPRECASantiago, 760 0448, Chile
Completed
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek SzakkorhazaDeszk, 6772, Hungary
Completed
Orszagos Koranyi TBC es Pulmonologiai IntezetBudapest, 1529, Hungary
Terminated
Bekes Megyei TudokorhazGyula, 5703, Hungary
Completed
Santa Casa de Misericórdia da Bahia Hospital Santa IzabelSalvador, 40050410, Brazil
Completed
Clínica Vila RicaBrasília, 70390907, Brazil
Completed
Centro Regional Integrado de Oncologia - CRIOFortaleza, 60336-550, Brazil
Completed
Hospital das Clínicas da Faculdade de Medicina da USPSão Paulo, 05403-000, Brazil
Completed
Santo Andre Diagnostico e TerapeuticaSanto Andre, 09090-780, Brazil
Completed
Hosp. Araujo Jorge da Associação de Combate ao CâncerGoiânia, 74605-180, Brazil
Completed
Hospital Municipal Sao JoséJoinville, 89202-050, Brazil
Completed
Hospital Amaral CarvalhoJaú, 17210-120, Brazil
Completed
Conjunto Hospitalar de SorocabaSorocaba, 18030-510, Brazil
Terminated
UNIFESP/EPMSão Paulo, 04024-002, Brazil
Completed
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russia
Terminated
Research Centre of X-ray and RadiologyMoscow, 117837, Russia
Terminated
Seoul National University HospitalSeoul, 110-799, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135710, Korea, Republic Of
Completed
National Taiwan University HospitalTaipei, 110, Taiwan

Primary Outcome

  • Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Progression Free Survival (PFS)
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Overall Best Response
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    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 (1Oct2007) used for planned formal interim analysis
    enhanced_encryption
    Safety Issue:
    No
  • Patient Reported Outcome as Assessed by LCS Subsscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)
    date_rangeTime Frame:
    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 (1Oct2007) used for planned formal interim analysis
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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