Trial Condition(s):

Carcinoma, Non-Small Cell Lung

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)

Bayer Identifier:

11961

ClinicalTrials.gov Identifier:

NCT00300885

EudraCT Number:

2005-005245-19

Terminated/Withdrawn

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.

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

Trial Summary

Enrollment Goal
926
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Lungenklinik Hemer

Hemer, Germany, 58675

Status
Completed
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

Status
Completed
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

Status
Completed
 
Locations

Asklepios Fachkliniken München Gauting

Gauting, Germany, 82131

Status
Completed
 
Locations

Krankenhaus Grosshansdorf

Großhansdorf, Germany, 22927

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37075

Status
Completed
 
Locations

Pius-Hospital Oldenburg

Oldenburg, Germany, 26121

Status
Terminated
 
Locations

Guy's Hospital

London, United Kingdom, SE1 9RT

Status
Terminated
 
Locations

Berkshire Hematology/Oncology, PC

Pittsfield, United States, 01201

Status
Completed
 
Locations

Gabrail Cancer Center

Dover, United States, 44622

Status
Terminated
 
Locations

Asklepios Klinik Harburg

Hamburg, Germany, 21075

Status
Completed
 
Locations

Klinikum Leverkusen gGmbH

Leverkusen, Germany, 51375

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Kliniken Essen - Mitte

Essen, Germany, 45136

Status
Completed
 
Locations

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Germany, 69126

Status
Completed
 
Locations

Krankenhaus Hofheim am Taunus

Hofheim , Germany, 65719

Status
Completed
 
Locations

Royal Bournemouth General Hospital

Bornemouth, United Kingdom, BH7 7DW

Status
Completed
 
Locations

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Status
Completed
 
Locations

Wythenshawe Hospital

Manchester, United Kingdom, M23 9LT

Status
Completed
 
Locations

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
Locations

Medical Oncology Care Associates

Orange, United States, 92868

Status
Terminated
 
Locations

Morgantown Internal Medicine Group, Inc.

Morgantown, United States, 26505

Status
Terminated
 
Locations

Clintell, Inc.

Skokie, United States, 60077

Status
Completed
 
Locations

Capital Comprehensive Cancer Care Clinic

Jefferson City, United States, 65109

Status
Completed
 
Locations

Hattiesburg Clinic

Hattiesburg, United States, 39401

Status
Completed
 
Locations

Cancer Outreach Associates

Abingdon, United States, 24211

Status
Completed
 
Locations

Hematology/Oncology of Indiana

Indianapolis, United States, 46260

Status
Terminated
 
Locations

Pacific Oncology/Hematology Associates

Encinitas, United States, 92024

Status
Terminated
 
Locations

Mount Sinai Medical Center

New York, United States, 10029

Status
Terminated
 
Locations

Siouxland Hematology/Oncology Associates, LLP

Sioux City, United States, 51101

Status
Completed
 
Locations

Sanford Roger Maris Cancer Center

Fargo, United States, 58122

Status
Terminated
 
Locations

Cancer Care Associates

Tulsa, United States, 74136

Status
Completed
 
Locations

Highlands Oncology Group

Springdale, United States, 72764

Status
Completed
 
Locations

St. John's Mercy Medical Center

St. Louis, United States, 63141

Status
Completed
 
Locations

Hematology & Oncology Consultants, PA

Orlando, United States, 32804

Status
Completed
 
Locations

Watson Clinic Center for Research

Lakeland, United States, 33805

Status
Completed
 
Locations

Tenessee Cancer Specialists

Knoxville, United States, 37920

Status
Completed
 
Locations

Jayne Gurtler APMC

Metairie, United States, 70006

Status
Completed
 
Locations

Simon-Williamson Clinic, PC

Birmingham, United States, 35211

Status
Completed
 
Locations

Fairfax-Northern Virginia Hematology/Oncology, PC

Fairfax, United States, 22031

Status
Completed
 
Locations

St. Joseph Mercy Hospital

Ann Arbor, United States, 48106

Status
Completed
 
Locations

Peachtree Hematology & Oncology Consultants, PC

Atlanta, United States, 30309

Status
Completed
 
Locations

Lehigh Valley Hospital - Cedar Crest

Allentown, United States, 18103

Status
Terminated
 
Locations

Oklahoma University Health Science Center

Oklahoma City, United States, 73104

Status
Completed
 
Locations

Hematology/Oncology Clinic

Baton Rouge, United States, 70808

Status
Completed
 
Locations

Las Vegas Cancer Center

Las Vegas, United States, 89102

Status
Terminated
 
Locations

University of Utah Medical Center

Salt Lake City, United States, 84112

Status
Completed
 
Locations

Cancer Centers of the Carolinas

Greenville, United States, 29615

Status
Completed
 
Locations

Virginia Oncology Care, PC

Richlands, United States, 24641

Status
Completed
 
Locations

Arkansas Oncology Associates

Little Rock, United States, 72205

Status
Completed
 
Locations

Kentuckiana Cancer Institute, PLLC

Louisville, United States, 40215

Status
Completed
 
Locations

Providence Portland Medical Center

Portland, United States, 97213

Status
Terminated
 
Locations

Arlington Cancer Center

Trophy Club, United States, 76262

Status
Completed
 
Locations

Hackensack University Medical Center

Hackensack, United States, 07601

Status
Completed
 
Locations

Hematology/Oncology Associates of Northern New Jersey, PA

Morristown, United States, 07962-1089

Status
Terminated
 
Locations

Office of Dr. William Tester, MD

Philadelphia, United States, 19115

Status
Completed
 
Locations

Hematology & Oncology of Dayton, Inc.

Dayton, United States, 45429

Status
Completed
 
Locations

Staten Island University Hospital

Staten Island, United States, 10305

Status
Terminated
 
Locations

East Valley Hematology/Oncology Medical Group

Burbank, United States, 91595

Status
Completed
 
Locations

Odyssey Research Services

Bismarck, United States, 58501

Status
Terminated
 
Locations

Henry Ford Health System

Detroit, United States, 48202

Status
Completed
 
Locations

Oncology-Hematology of Lehigh Valley, PC

Bethlehem, United States, 18015

Status
Completed
 
Locations

Sacred Heart Medical Oncology Group

Mobile, United States, 36608

Status
Completed
 
Locations

Metropolitan Hematology Oncology Medical Group

Los Angeles, United States, 90057

Status
Completed
 
Locations

University of Chicago

Chicago, United States, 60637

Status
Completed
 
Locations

Kansas City Cancer Centers, LLC

Kansas City, United States, 64111

Status
Terminated
 
Locations

Rocky Mountain Cancer Centers

Denver, United States, 80218

Status
Completed
 
Locations

Howard Regional Health System-Main Campus

Kokomo, United States, 46902

Status
Terminated
 
Locations

Compassionate Cancer Care Medical Group, Inc.

Corona, United States, 92829

Status
Completed
 
Locations

Southeast Nebraska Cancer Center

Lincoln, United States, 68510

Status
Terminated
 
Locations

Northwest Georgia Oncology Centers, PC

Marietta, United States, 30060

Status
Completed
 
Locations

Indiana University

Indianapolis, United States, 46202

Status
Completed
 
Locations

Candler Hospital/St. Joseph's Candler Health System

Savannah, United States, 31405

Status
Completed
 
Locations

Fort Wayne Medical Hematology & Oncology

Fort Wayne, United States, 46815

Status
Completed
 
Locations

Centre François Baclesse - CLCC - Caen

CAEN, France, 14073

Status
Completed
 
Locations

ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

Olsztyn, Poland, 10-228

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-952

Status
Completed
 
Locations

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

Status
Completed
 
Locations

Dolnoslaskie Centrum Chorób Pluc

Wroclaw, Poland, 53-439

Status
Completed
 
Locations

A.O.U. San Luigi Gonzaga

Orbassano, Italy, 10043

Status
Completed
 
Locations

A.O. Città della Salute e della Scienza di Torino

Torino, Italy, 10126

Status
Completed
 
Locations

A.O. di Perugia

Perugia, Italy, 06156

Status
Completed
 
Locations

IRCCS Ist Nazionale Tumori GE

Genova, Italy, 16132

Status
Completed
 
Locations

A.O. San Camillo-Forlanini

Roma, Italy, 00152

Status
Completed
 
Locations

A.O.U. di Parma

Parma, Italy, 43100

Status
Completed
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

Hospital General de Elche

Elche, Spain, 03202

Status
Completed
 
Locations

Hospital General Universitario de Alicante

Alicante, Spain, 03010

Status
Terminated
 
Locations

Hospital Universitario Clinica Puerta de Hierro

Majadahonda, Spain, 28222

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Allan Blair Cancer Centre

Regina, Canada, S4T 7T1

Status
Completed
 
Locations

Allan Blair Cancer Centre

Regina, Canada, S4T 7T1

Status
Terminated
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Länssjukhuset Gävle-Sandviken

Gävle, Sweden, 801 87

Status
Completed
 
Locations

Port Macquarie Base Hospital

Port Macquarie, Australia, 2444

Status
Completed
 
Locations

Southeast Oncology

Melbourne, Australia, 3144

Status
Completed
 
Locations

Royal Brisbane & Women's Hospital

Brisbane, Australia, 4029

Status
Completed
 
Locations

Southern Medical Day Care Centre

Wollongong, Australia, 2500

Status
Completed
 
Locations

Instituto Médico Platense

La Plata, Argentina, B1900AVG

Status
Completed
 
Locations

Centro Especializado ISIS

Santa Fé, Argentina, S3000FFV

Status
Completed
 
Locations

Hospital Nacional Professor A. Posadas

El Palomar - Morón, Argentina, 1684

Status
Completed
 
Locations

Instituto C.A.I.C.I.

Rosario, Argentina, 2000

Status
Terminated
 
Locations

Hospital Privado de la Comunidad

Mar del Plata, Argentina, B7602CBM

Status
Completed
 
Locations

Centro de Cancer Nuestra Señora de la Esperanza

Santiago, Chile

Status
Completed
 
Locations

Matrai State Hospital

Matrahaza, Hungary, 3233

Status
Completed
 
Locations

Pest County Lung Institute

Torokbalint, Hungary, 2045

Status
Completed
 
Locations

Hospital IGESP

São Paulo, Brazil, 01331010

Status
Completed
 
Locations

Fundação Pio XII – Hospital de Câncer de Barretos

Barretos, Brazil, 14784400

Status
Completed
 
Locations

Irmandade da Santa Casa de Misericordia - Sao Paulo

São Paulo, Brazil

Status
Completed
 
Locations

Biocor Hospital de Doenzas Cardiovasculares Ltda

Nova Lima, Brazil, 34000000

Status
Completed
 
Locations

Instituto do Cancer do Ceará

Fortaleza, Brazil, 60430-230

Status
Completed
 
Locations

Hospital Sao Lucas da Pontificia Universidade Catolica do RS

Porto Alegre, Brazil, 90619900

Status
Completed
 
Locations

Centro de Oncologia do Paraná

Curitiba, Brazil, 80730-180

Status
Completed
 
Locations

CEON - Centro especializado de Oncologia

Ribeirao Preto, Brazil, 14015-140

Status
Terminated
 
Locations

Hospital Luxemburgo

Belo Horizonte, Brazil, 30380490

Status
Completed
 
Locations

Hospital Nossa Senhora da Conceicao

Porto Alegre, Brazil, 91350-200

Status
Completed
 
Locations

City Clinical Oncology Center

St. Petersburg, Russia, 198255

Status
Completed
 
Locations

Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

Moscow, Russia, 115478

Status
Completed
 
Locations

Moscow City Oncological Hospital No62

Moscow, Russia, 143423

Status
Terminated
 
Locations

Asan Medical Center

Seoul, South Korea, 138736

Status
Terminated
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Chang-Guang Memorial Hospital

Taoyuan, Taiwan, China, 333

Status
Completed
 
Locations

Queen Elizabeth Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

EPIC Management, LP

Highland, United States, 92346

Status
Completed
 
Locations

Tower Hematology/Oncology Medical Group

Beverly Hills, United States, 90211-1850

Status
Completed
 
Locations

Investigative Clinical Research of Indiana, LLC

Indianapolis, United States, 46254

Status
Completed
 
Locations

Virginia Commonwealth University

Richmond, United States, 23298-0037

Status
Completed
 
Locations

MD Anderson Cancer Center-Orlando

Orlando, United States, 32806

Status
Completed
 
Locations

Virginia Cancer Institute

Richmond, United States, 23230

Status
Completed
 
Locations

Vanderbilt University Medical School

Nashville, United States, 37232-6307

Status
Terminated
 
Locations

MD Anderson Cancer Center-Orlando

Orlando, United States, 32806

Status
Terminated
 
Locations

North Shore Cancer Research Association

Skokie, United States, 60076

Status
Terminated
 
Locations

Charleston Hematology & Oncology Associates, PA

Charleston, United States, 29403

Status
Completed
 
Locations

University of Rochester Medical Center

Rochester, United States, 14622

Status
Terminated
 
Locations

Kansas City Cancer Centers, LLC

Kansas City, United States, 64131

Status
Completed
 
Locations

Hematology Oncology Consultants, Inc.

Columbus, United States, 43235

Status
Completed
 
Locations

Mid-Ohio Oncololgy/Hematology

Columbus, United States, 43213

Status
Terminated
 
Locations

Arizona Clinical Research Center

Tucson, United States, 85715

Status
Terminated
 
Locations

Hutchinson Clinic

Hutchinson, United States, 67502

Status
Terminated
 
Locations

Pottsville Cancer Center

Pottsville, United States, 17901

Status
Terminated
 
Locations

Space Coast Medical Associates

Merritt Island, United States, 32952

Status
Completed
 
Locations

VA Boston Healthcare System-Jamaica Plain Division

Boston, United States, 02130

Status
Terminated
 
Locations

Southern Nevada Cancer Research Foundation

Las Vegas, United States, 89106

Status
Terminated
 
Locations

Pacific Cancer Medical Center

Anaheim, United States, 92801

Status
Terminated
 
Locations

San Juan VA Medical Center

San Juan, United States, 00921

Status
Terminated
 
Locations

Cancer Center of Kansas

Wichita, United States, 67214

Status
Terminated
 
Locations

Medical Consultants, Ltd.

Milwaukee, United States, 53215

Status
Terminated
 
Locations

Guthrie Clinic

Sayre, United States, 18840

Status
Completed
 
Locations

University of California - Davis

Sacramento, United States, 95817

Status
Terminated
 
Locations

Hopital Avicenne - Bobigny

BOBIGNY CEDEX, France, 93009

Status
Completed
 
Locations

Centre d'Oncologie de Gentilly - Nancy

NANCY, France, 54100

Status
Completed
 
Locations

Hopital Percy - Clamart

CLAMART, France, 92140

Status
Terminated
 
Locations

Centre Antoine Lacassagne - Nice

NICE CEDEX 2, France, 06102

Status
Completed
 
Locations

Hôpital Bon Secours - Metz

METZ, France, 57000

Status
Terminated
 
Locations

Hopital Lyautey - Strasbourg

STRASBOURG, France, 67100

Status
Completed
 
Locations

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141

Status
Completed
 
Locations

Mazowieckie Centrum Leczenia Ch. Pluc i Gruzlicy

Otwock, Poland, 05-400

Status
Terminated
 
Locations

A.O.U. di Parma

Parma, Italy, 43100

Status
Terminated
 
Locations

A.O. Osp Niguarda Ca' Granda

Milano, Italy, 20162

Status
Completed
 
Locations

A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Ruber Internacional

Madrid, Spain, 28034

Status
Completed
 
Locations

Complejo Hospitalario de Pontevedra

Pontevedra, Spain, 36001

Status
Terminated
 
Locations

Complejo Hospitalario de Zamora

Zamora, Spain, 49021

Status
Completed
 
Locations

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain, 50009

Status
Terminated
 
Locations

Hospital Universitario de la Princesa

Madrid, Spain, 28006

Status
Terminated
 
Locations

Office of Dr. Sandeep Sehdev, MD

Brampton, Canada, L6W 3X4

Status
Completed
 
Locations

University of British Columbia

North Vancouver, Canada, V7L 2L7

Status
Completed
 
Locations

Royal Victoria Hospital

Barrie, Canada, L4M 6M2

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Grand Hôpital de Charleroi

CHARLEROI, Belgium, 6000

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

CH de Jolimont - Lobbes Site de Jolimont

LA LOUVIERE, Belgium, 7100

Status
Terminated
 
Locations

Isala Klinieken, lokatie Weezenlanden

Zwolle, Netherlands, 8011 JW

Status
Completed
 
Locations

Catharina

EINDHOVEN, Netherlands, 5623 EJ

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Perth Oncology

Perth, Australia, 6000

Status
Terminated
 
Locations

Burnside War Memorial Hospital

Adelaide, Australia, 5065

Status
Terminated
 
Locations

Peninsula Oncology Centre

Frankston, Australia, 3199

Status
Completed
 
Locations

Hospital General de Agudos Dr. Carlos G. Durand

Buenos Aires, Argentina, C1405DCS

Status
Completed
 
Locations

Instituto Medico Especializado Alexander Fleming

Capital Federal-Buenos Aires, Argentina, C1426ANZ

Status
Completed
 
Locations

Instituto Nacional del Cancer

Santiago, Chile, 838-0455

Status
Completed
 
Locations

Hospital Clínico San Borja Arriarán

Santiago, Chile, 836-0156

Status
Completed
 
Locations

Hospital DIPRECA

Santiago, Chile, 760 0448

Status
Completed
 
Locations

Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza

Deszk, Hungary, 6772

Status
Completed
 
Locations

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, Hungary, 1529

Status
Completed
 
Locations

Bekes Megyei Tudokorhaz

Gyula, Hungary, 5703

Status
Terminated
 
Locations

Santa Casa de Misericórdia da Bahia Hospital Santa Izabel

Salvador, Brazil, 40050410

Status
Completed
 
Locations

Clínica Vila Rica

Brasília , Brazil, 70390907

Status
Completed
 
Locations

Centro Regional Integrado de Oncologia - CRIO

Fortaleza, Brazil, 60336-550

Status
Completed
 
Locations

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil, 05403-000

Status
Completed
 
Locations

Santo Andre Diagnostico e Terapeutica

Santo Andre, Brazil, 09090-780

Status
Completed
 
Locations

Hosp. Araujo Jorge da Associação de Combate ao Câncer

Goiânia, Brazil, 74605-180

Status
Completed
 
Locations

Hospital Municipal Sao José

Joinville, Brazil, 89202-050

Status
Completed
 
Locations

Hospital Amaral Carvalho

Jaú, Brazil, 17210-120

Status
Completed
 
Locations

Conjunto Hospitalar de Sorocaba

Sorocaba, Brazil, 18030-510

Status
Completed
 
Locations

UNIFESP/EPM

São Paulo, Brazil, 04024-002

Status
Terminated
 
Locations

Research Centre of X-ray and Radiology

Moscow, Russia, 117837

Status
Terminated
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-799

Status
Terminated
 
Locations

Samsung Medical Center

Seoul, South Korea, 135710

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 110

Status
Completed
 

Trial Design