Lung Cancer Clinical Trial

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).

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
patients must have failed at least one but no more than two standard chemotherapy regimens;
measurable disease according to the RECIST criteria;
Eastern Cooperative Oncology Group (ECOG) performance status;
life expectancy >12 weeks.

Exclusion Criteria:

patients with active central nervous system (CNS) lesions;
prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R) inhibition or epidermal growth factor receptor (EGFR) targeting;
administration with high doses of systemic corticosteroids;
radiotherapy in the 4 weeks prior to study start;
surgery or significant traumatic injury with in the last 2 weeks prior to study start.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

171

Study ID:

NCT00760929

Recruitment Status:

Terminated

Sponsor:

Hoffmann-La Roche

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There are 57 Locations for this study

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Tower Cancer Research Foundation
Beverly Hills California, 90211, United States
Florida Cancer Inst.
New Port Richey Florida, 34655, United States
Emory Univ Winship Cancer Inst
Atlanta Georgia, 30322, United States
University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
Chicago Illinois, 60637, United States
North Shore University Health System
Glenview Illinois, 60026, United States
Joliet Oncology Hematology Associates, Ltd.
Joliet Illinois, 60435, United States
St. Joseph Medical Center
Towson Maryland, 21204, United States
Massachusetts General Hospital.
Boston Massachusetts, 02114, United States
Dana Farber Cancer Inst.
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Carolina Oncology Specialists, PA - Hickory
Hickory North Carolina, 28602, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga Tennessee, 37404, United States
Sarah Cannon Research Inst.
Nashville Tennessee, 37203, United States
Virginia Cancer Institute
Richmond Virginia, 23226, United States
Flinders Medical Center; Medical Oncology
Adelaide South Australia, 5041, Australia
Frankston Hospital; Oncology/Haematology
Frankston Victoria, 3199, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
GHdC Site Notre Dame
Charleroi , 6000, Belgium
UZ Antwerpen
Edegem , 2650, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Chr de La Citadelle
Liege , 3500, Belgium
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie
La Tronche , 38700, France
Hopital de La Croix Rousse; Service de Pneumologie
Lyon , 69317, France
Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie
Paris , 75674, France
Hopital Tenon;Pneumologie
Paris , 75970, France
Hopital Larrey; Clinique Des Voies Respiratoires
Toulouse , 31400, France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka , 99437, Germany
Helios Klinikum Emil von Behring GmbH
Berlin , 14165, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
Halle (Saale) , 06120, Germany
Asklepios Klinik Harburg; Thoraxzentrum
Hamburg , 21075, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
Herne , 44625, Germany
Klinikum Leverkusen; Med. Klinik III / Onkologie
Leverkusen , 51375, Germany
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
Muenchen , 80336, Germany
St. James Hospital; Oncology
Dublin , 8, Ireland
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia Emilia-Romagna, 42100, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova Liguria, 16132, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milano Lombardia, 20162, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano Piemonte, 10043, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
Medical University of Gdansk
Gdansk , 80-95, Poland
SK Przemienienia Panskiego UM im.K.Marcinkowskiego
Poznan , 60-56, Poland
Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii
Szczecin , 70-89, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warszawa , 02-78, Poland
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda Madrid, 28222, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao Vizcaya, 48903, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga , 29010, Spain
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford , GU2 7, United Kingdom
Wythenshawe Hospital; North West Lung Centre
Manchester , M23 9, United Kingdom
Sir Bobby Robson Cancer Research Centre
Newcastle Upon Tyne , NE7 7, United Kingdom
New Cross Hospital; Deansley Centre
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

171

Study ID:

NCT00760929

Recruitment Status:

Terminated

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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