Spots Global Cancer Trial Database for A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
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Trial Identification
Brief Title: A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
Official Title: A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progression After First or Second Line Chemotherapy
Study ID: NCT00760929
Conditions
Study Description
Brief Summary: This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<500 individuals.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tower Cancer Research Foundation, Beverly Hills, California, United States
Florida Cancer Inst., New Port Richey, Florida, United States
Emory Univ Winship Cancer Inst, Atlanta, Georgia, United States
University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology, Chicago, Illinois, United States
North Shore University Health System, Glenview, Illinois, United States
Joliet Oncology Hematology Associates, Ltd., Joliet, Illinois, United States
St. Joseph Medical Center, Towson, Maryland, United States
Massachusetts General Hospital., Boston, Massachusetts, United States
Dana Farber Cancer Inst., Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Carolina Oncology Specialists, PA - Hickory, Hickory, North Carolina, United States
Chattanooga Oncology and Hematology Associates, PC, Chattanooga, Tennessee, United States
Sarah Cannon Research Inst., Nashville, Tennessee, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Flinders Medical Center; Medical Oncology, Adelaide, South Australia, Australia
Frankston Hospital; Oncology/Haematology, Frankston, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Chr de La Citadelle, Liege, , Belgium
Lakeridge Health Oshawa; Oncology, Oshawa, Ontario, Canada
Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie, La Tronche, , France
Hopital de La Croix Rousse; Service de Pneumologie, Lyon, , France
Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie, Paris, , France
Hopital Tenon;Pneumologie, Paris, , France
Hopital Larrey; Clinique Des Voies Respiratoires, Toulouse, , France
Zentralklinik Bad Berka GmbH; Pneumologie, Bad Berka, , Germany
Helios Klinikum Emil von Behring GmbH, Berlin, , Germany
LungenClinic Großhansdorf GmbH, Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I, Halle (Saale), , Germany
Asklepios Klinik Harburg; Thoraxzentrum, Hamburg, , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik, Herne, , Germany
Klinikum Leverkusen; Med. Klinik III / Onkologie, Leverkusen, , Germany
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik, Muenchen, , Germany
St. James Hospital; Oncology, Dublin, , Ireland
Arcispedale Santa Maria Nuova; Oncologia, Reggio Emilia, Emilia-Romagna, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A, Genova, Liguria, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milano, Lombardia, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico, Orbassano, Piemonte, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Sant'Andrea Delle Fratte (PG), Umbria, Italy
Medical University of Gdansk, Gdansk, , Poland
SK Przemienienia Panskiego UM im.K.Marcinkowskiego, Poznan, , Poland
Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii, Szczecin, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii, Warszawa, , Poland
Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Majadahonda, Madrid, Spain
Hospital de Cruces; Servicio de Oncologia, Bilbao, Vizcaya, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Malaga, , Spain
Royal Surrey County Hospital; St. Lukes Cancer Centre, Guildford, , United Kingdom
Wythenshawe Hospital; North West Lung Centre, Manchester, , United Kingdom
Sir Bobby Robson Cancer Research Centre, Newcastle Upon Tyne, , United Kingdom
New Cross Hospital; Deansley Centre, Wolverhampton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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