stop_circleTerminated/Withdrawn
Carcinoma, Non-Small Cell Lung
Bayer Identifier:
11961
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 YearsTrial summary
Enrollment Goal
926Trial Dates
February 2006 - February 2009Phase
Phase 3Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kliniken der Medizinischen Hochschule Hannover | Hannover, 30625, Germany |
Completed | Universitätsklinikum Essen | Essen, 45122, Germany |
Completed | Lungenklinik Hemer | Hemer, 58675, Germany |
Completed | Klinikum Innenstadt der Ludwigs-Maximilians-Universität | München, 80336, Germany |
Completed | Klinikum Mannheim gGmbH | Mannheim, 68167, Germany |
Completed | Asklepios Fachkliniken München Gauting | Gauting, 82131, Germany |
Completed | Krankenhaus Grosshansdorf | Großhansdorf, 22927, Germany |
Completed | Johannes-Gutenberg-Universität Mainz | Mainz, 55131, Germany |
Completed | Universitätsmedizin der Georg-August-Universität Göttingen | Göttingen, 37075, Germany |
Terminated | Pius-Hospital Oldenburg | Oldenburg, 26121, Germany |
Terminated | Guy's Hospital | London, SE1 9RT, United Kingdom |
Terminated | Guy's Hospital | London, SE1 9RT, United Kingdom |
Completed | Berkshire Hematology/Oncology, PC | Pittsfield, 01201, United States |
Terminated | Gabrail Cancer Center | Dover, 44622, United States |
Completed | Asklepios Klinik Harburg | Hamburg, 21075, Germany |
Completed | Klinikum Leverkusen gGmbH | Leverkusen, 51375, Germany |
Completed | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Completed | Kliniken Essen - Mitte | Essen, 45136, Germany |
Completed | Thoraxklinik-Heidelberg gGmbH | Heidelberg, 69126, Germany |
Completed | Krankenhaus Hofheim am Taunus | Hofheim, 65719, Germany |
Completed | Royal Bournemouth General Hospital | Bornemouth, BH7 7DW, United Kingdom |
Completed | Derriford Hospital | Plymouth, PL6 8DH, United Kingdom |
Completed | Wythenshawe Hospital | Manchester, M23 9LT, United Kingdom |
Completed | Leicester Royal Infirmary | Leicester, LE1 5WW, United Kingdom |
Terminated | Guy's Hospital | London, SE1 9RT, United Kingdom |
Terminated | Guy's Hospital | London, SE1 9RT, United Kingdom |
Terminated | Medical Oncology Care Associates | Orange, 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 Clinic | Jefferson City, 65109, United States |
Completed | Hattiesburg Clinic | Hattiesburg, 39401, United States |
Completed | Cancer Outreach Associates | Abingdon, 24211, United States |
Terminated | Hematology/Oncology of Indiana | Indianapolis, 46260, United States |
Terminated | Pacific Oncology/Hematology Associates | Encinitas, 92024, United States |
Terminated | Mount Sinai Medical Center | New York, 10029, United States |
Completed | Siouxland Hematology/Oncology Associates, LLP | Sioux City, 51101, United States |
Terminated | Sanford Roger Maris Cancer Center | Fargo, 58122, United States |
Completed | Cancer Care Associates | Tulsa, 74136, United States |
Completed | Highlands Oncology Group | Springdale, 72764, United States |
Completed | St. John's Mercy Medical Center | St. Louis, 63141, United States |
Completed | Hematology & Oncology Consultants, PA | Orlando, 32804, United States |
Completed | Watson Clinic Center for Research | Lakeland, 33805, United States |
Completed | Tenessee Cancer Specialists | Knoxville, 37920, United States |
Completed | Jayne Gurtler APMC | Metairie, 70006, United States |
Completed | Simon-Williamson Clinic, PC | Birmingham, 35211, United States |
Completed | Fairfax-Northern Virginia Hematology/Oncology, PC | Fairfax, 22031, United States |
Completed | St. Joseph Mercy Hospital | Ann Arbor, 48106, United States |
Completed | Peachtree Hematology & Oncology Consultants, PC | Atlanta, 30309, United States |
Terminated | Lehigh Valley Hospital - Cedar Crest | Allentown, 18103, United States |
Completed | Oklahoma University Health Science Center | Oklahoma City, 73104, United States |
Completed | Hematology/Oncology Clinic | Baton Rouge, 70808, United States |
Terminated | Las Vegas Cancer Center | Las Vegas, 89102, United States |
Completed | University of Utah Medical Center | Salt Lake City, 84112, United States |
Completed | Cancer Centers of the Carolinas | Greenville, 29615, United States |
Completed | Virginia Oncology Care, PC | Richlands, 24641, United States |
Completed | Arkansas Oncology Associates | Little Rock, 72205, United States |
Completed | Kentuckiana Cancer Institute, PLLC | Louisville, 40215, United States |
Terminated | Providence Portland Medical Center | Portland, 97213, United States |
Completed | Arlington Cancer Center | Trophy Club, 76262, United States |
Completed | Hackensack University Medical Center | Hackensack, 07601, United States |
Terminated | Hematology/Oncology Associates of Northern New Jersey, PA | Morristown, 07962-1089, United States |
Completed | Office of Dr. William Tester, MD | Philadelphia, 19115, United States |
Completed | Hematology & Oncology of Dayton, Inc. | Dayton, 45429, United States |
Terminated | Staten Island University Hospital | Staten Island, 10305, United States |
Completed | East Valley Hematology/Oncology Medical Group | Burbank, 91595, United States |
Terminated | Odyssey Research Services | Bismarck, 58501, United States |
Completed | Henry Ford Health System | Detroit, 48202, United States |
Completed | Oncology-Hematology of Lehigh Valley, PC | Bethlehem, 18015, United States |
Completed | Sacred Heart Medical Oncology Group | Mobile, 36608, United States |
Completed | Metropolitan Hematology Oncology Medical Group | Los Angeles, 90057, United States |
Completed | University of Chicago | Chicago, 60637, United States |
Terminated | Kansas City Cancer Centers, LLC | Kansas City, 64111, United States |
Completed | Rocky Mountain Cancer Centers | Denver, 80218, United States |
Terminated | Howard Regional Health System-Main Campus | Kokomo, 46902, United States |
Completed | Compassionate Cancer Care Medical Group, Inc. | Corona, 92829, United States |
Terminated | Southeast Nebraska Cancer Center | Lincoln, 68510, United States |
Completed | Northwest Georgia Oncology Centers, PC | Marietta, 30060, United States |
Completed | Indiana University | Indianapolis, 46202, United States |
Completed | Candler Hospital/St. Joseph's Candler Health System | Savannah, 31405, United States |
Completed | Fort Wayne Medical Hematology & Oncology | Fort Wayne, 46815, United States |
Completed | Centre François Baclesse - CLCC - Caen | CAEN, 14073, France |
Completed | ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii | Olsztyn, 10-228, Poland |
Completed | Uniwersyteckie Centrum Kliniczne | Gdansk, 80-952, Poland |
Completed | Centrum Onkologii Instytut im. M. Sklodowskiej-Curie | Krakow, 31-115, Poland |
Completed | Dolnoslaskie Centrum Chorób Pluc | Wroclaw, 53-439, Poland |
Completed | A.O.U. San Luigi Gonzaga | Orbassano, 10043, Italy |
Completed | A.O. Città della Salute e della Scienza di Torino | Torino, 10126, Italy |
Completed | A.O. di Perugia | Perugia, 06156, Italy |
Completed | IRCCS Ist Nazionale Tumori GE | Genova, 16132, Italy |
Completed | A.O. San Camillo-Forlanini | Roma, 00152, Italy |
Completed | A.O.U. di Parma | Parma, 43100, Italy |
Completed | IRCCS Policlinico San Matteo | Pavia, 27100, Italy |
Completed | Hospital General de Elche | Elche, 03202, Spain |
Terminated | Hospital General Universitario de Alicante | Alicante, 03010, Spain |
Completed | Hospital Universitario Clinica Puerta de Hierro | Majadahonda, 28222, Spain |
Completed | Sir Mortimer B. Davis Jewish General Hospital | Montreal, H3T 1E2, Canada |
Completed | Allan Blair Cancer Centre | Regina, S4T 7T1, Canada |
Terminated | Allan Blair Cancer Centre | Regina, S4T 7T1, Canada |
Completed | Karolinska Universitetssjukhuset i Solna | Stockholm, 171 76, Sweden |
Completed | Länssjukhuset Gävle-Sandviken | Gävle, 801 87, Sweden |
Completed | Port Macquarie Base Hospital | Port Macquarie, 2444, Australia |
Completed | Southeast Oncology | Melbourne, 3144, Australia |
Completed | Royal Brisbane & Women's Hospital | Brisbane, 4029, Australia |
Completed | Southern Medical Day Care Centre | Wollongong, 2500, Australia |
Completed | Instituto Médico Platense | La Plata, B1900AVG, Argentina |
Completed | Centro Especializado ISIS | Santa Fé, S3000FFV, Argentina |
Completed | Hospital Nacional Professor A. Posadas | El Palomar - Morón, 1684, Argentina |
Terminated | Instituto C.A.I.C.I. | Rosario, 2000, Argentina |
Completed | Hospital Privado de la Comunidad | Mar del Plata, B7602CBM, Argentina |
Completed | Centro de Cancer Nuestra Señora de la Esperanza | Santiago, Chile |
Completed | Matrai State Hospital | Matrahaza, 3233, Hungary |
Completed | Pest County Lung Institute | Torokbalint, 2045, Hungary |
Completed | Hospital IGESP | São Paulo, 01331010, Brazil |
Completed | Fundação Pio XII – Hospital de Câncer de Barretos | Barretos, 14784400, Brazil |
Completed | Irmandade da Santa Casa de Misericordia - Sao Paulo | São Paulo, Brazil |
Completed | Biocor Hospital de Doenzas Cardiovasculares Ltda | Nova Lima, 34000000, Brazil |
Completed | Instituto do Cancer do Ceará | Fortaleza, 60430-230, Brazil |
Completed | Hospital Sao Lucas da Pontificia Universidade Catolica do RS | Porto Alegre, 90619900, Brazil |
Completed | Centro de Oncologia do Paraná | Curitiba, 80730-180, Brazil |
Terminated | CEON - Centro especializado de Oncologia | Ribeirao Preto, 14015-140, Brazil |
Completed | Hospital Luxemburgo | Belo Horizonte, 30380490, Brazil |
Completed | Hospital Nossa Senhora da Conceicao | Porto Alegre, 91350-200, Brazil |
Completed | City Clinical Oncology Center | St. Petersburg, 198255, Russia |
Completed | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115478, Russia |
Terminated | Moscow City Oncological Hospital No62 | Moscow, 143423, Russia |
Terminated | Asan Medical Center | Seoul, 138736, Korea, Republic Of |
Completed | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Completed | Chang-Guang Memorial Hospital | Taoyuan, 333, Taiwan |
Completed | Queen Elizabeth Hospital | Hong Kong, Hong Kong |
Completed | EPIC Management, LP | Highland, 92346, United States |
Completed | Tower Hematology/Oncology Medical Group | Beverly Hills, 90211-1850, United States |
Completed | Investigative Clinical Research of Indiana, LLC | Indianapolis, 46254, United States |
Completed | Virginia Commonwealth University | Richmond, 23298-0037, United States |
Completed | MD Anderson Cancer Center-Orlando | Orlando, 32806, United States |
Completed | Virginia Cancer Institute | Richmond, 23230, United States |
Terminated | Vanderbilt University Medical School | Nashville, 37232-6307, United States |
Terminated | MD Anderson Cancer Center-Orlando | Orlando, 32806, United States |
Terminated | North Shore Cancer Research Association | Skokie, 60076, United States |
Completed | Charleston Hematology & Oncology Associates, PA | Charleston, 29403, United States |
Terminated | University of Rochester Medical Center | Rochester, 14622, United States |
Completed | Kansas City Cancer Centers, LLC | Kansas City, 64131, United States |
Completed | Hematology Oncology Consultants, Inc. | Columbus, 43235, United States |
Terminated | Mid-Ohio Oncololgy/Hematology | Columbus, 43213, United States |
Terminated | Arizona Clinical Research Center | Tucson, 85715, United States |
Terminated | Mount Sinai Medical Center | New York, 10029, United States |
Terminated | Hutchinson Clinic | Hutchinson, 67502, United States |
Terminated | Pottsville Cancer Center | Pottsville, 17901, United States |
Completed | Space Coast Medical Associates | Merritt Island, 32952, United States |
Terminated | VA Boston Healthcare System-Jamaica Plain Division | Boston, 02130, United States |
Terminated | Southern Nevada Cancer Research Foundation | Las Vegas, 89106, United States |
Terminated | Pacific Cancer Medical Center | Anaheim, 92801, United States |
Terminated | San Juan VA Medical Center | San Juan, 00921, United States |
Terminated | Cancer Center of Kansas | Wichita, 67214, United States |
Terminated | Medical Consultants, Ltd. | Milwaukee, 53215, United States |
Completed | Guthrie Clinic | Sayre, 18840, United States |
Terminated | University of California - Davis | Sacramento, 95817, United States |
Completed | Hopital Avicenne - Bobigny | BOBIGNY CEDEX, 93009, France |
Completed | Centre d'Oncologie de Gentilly - Nancy | NANCY, 54100, France |
Terminated | Hopital Percy - Clamart | CLAMART, 92140, France |
Completed | Centre Antoine Lacassagne - Nice | NICE CEDEX 2, 06102, France |
Terminated | Hôpital Bon Secours - Metz | METZ, 57000, France |
Completed | Hopital Lyautey - Strasbourg | STRASBOURG, 67100, France |
Completed | Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie | Warszawa, 02-781, Poland |
Completed | Wojskowy Instytut Medyczny | Warszawa, 04-141, Poland |
Terminated | Mazowieckie Centrum Leczenia Ch. Pluc i Gruzlicy | Otwock, 05-400, Poland |
Terminated | A.O.U. di Parma | Parma, 43100, Italy |
Completed | A.O. Osp Niguarda Ca' Granda | Milano, 20162, Italy |
Completed | A.O. Ospedali Riuniti Bergamo | Bergamo, 24128, Italy |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Hospital Ruber Internacional | Madrid, 28034, Spain |
Terminated | Complejo Hospitalario de Pontevedra | Pontevedra, 36001, Spain |
Completed | Complejo Hospitalario de Zamora | Zamora, 49021, Spain |
Terminated | Hospital Clínico Universitario Lozano Blesa | Zaragoza, 50009, Spain |
Terminated | Hospital Universitario de la Princesa | Madrid, 28006, Spain |
Completed | Office of Dr. Sandeep Sehdev, MD | Brampton, L6W 3X4, Canada |
Completed | University of British Columbia | North Vancouver, V7L 2L7, Canada |
Completed | Royal Victoria Hospital | Barrie, L4M 6M2, Canada |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | Grand Hôpital de Charleroi | CHARLEROI, 6000, Belgium |
Completed | CHU de Liège | LIEGE, 4000, Belgium |
Terminated | CH de Jolimont - Lobbes Site de Jolimont | LA LOUVIERE, 7100, Belgium |
Completed | Isala Klinieken, lokatie Weezenlanden | Zwolle, 8011 JW, Netherlands |
Completed | Catharina | EINDHOVEN, 5623 EJ, Netherlands |
Completed | Akademiska Sjukhuset | Uppsala, 751 85, Sweden |
Terminated | Perth Oncology | Perth, 6000, Australia |
Terminated | Burnside War Memorial Hospital | Adelaide, 5065, Australia |
Completed | Peninsula Oncology Centre | Frankston, 3199, Australia |
Completed | Hospital General de Agudos Dr. Carlos G. Durand | Buenos Aires, C1405DCS, Argentina |
Completed | Instituto Medico Especializado Alexander Fleming | Capital Federal-Buenos Aires, C1426ANZ, Argentina |
Completed | Instituto Nacional del Cancer | Santiago, 838-0455, Chile |
Completed | Hospital Clínico San Borja Arriarán | Santiago, 836-0156, Chile |
Completed | Hospital DIPRECA | Santiago, 760 0448, Chile |
Completed | Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza | Deszk, 6772, Hungary |
Completed | Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest, 1529, Hungary |
Terminated | Bekes Megyei Tudokorhaz | Gyula, 5703, Hungary |
Completed | Santa Casa de Misericórdia da Bahia Hospital Santa Izabel | Salvador, 40050410, Brazil |
Completed | Clínica Vila Rica | Brasília, 70390907, Brazil |
Completed | Centro Regional Integrado de Oncologia - CRIO | Fortaleza, 60336-550, Brazil |
Completed | Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo, 05403-000, Brazil |
Completed | Santo Andre Diagnostico e Terapeutica | Santo Andre, 09090-780, Brazil |
Completed | Hosp. Araujo Jorge da Associação de Combate ao Câncer | Goiânia, 74605-180, Brazil |
Completed | Hospital Municipal Sao José | Joinville, 89202-050, Brazil |
Completed | Hospital Amaral Carvalho | Jaú, 17210-120, Brazil |
Completed | Conjunto Hospitalar de Sorocaba | Sorocaba, 18030-510, Brazil |
Terminated | UNIFESP/EPM | São Paulo, 04024-002, Brazil |
Completed | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115478, Russia |
Terminated | Research Centre of X-ray and Radiology | Moscow, 117837, Russia |
Terminated | Seoul National University Hospital | Seoul, 110-799, Korea, Republic Of |
Completed | Samsung Medical Center | Seoul, 135710, Korea, Republic Of |
Completed | National Taiwan University Hospital | Taipei, 110, Taiwan |
Primary Outcome
- Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebodate_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 analysisenhanced_encryptionNoSafety Issue:
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 analysisenhanced_encryptionNoSafety Issue:
- Overall Best Responsedate_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 analysisenhanced_encryptionNoSafety Issue:
- Duration of Responsedate_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 analysisenhanced_encryptionNoSafety Issue:
- 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 analysisenhanced_encryptionNoSafety Issue:
- 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 analysisenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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