Spots Global Cancer Trial Database for AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
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Trial Identification
Brief Title: AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
Official Title: AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study ID: NCT00976911
Conditions
Study Description
Brief Summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Institut Jules Bordet, Bruxelles, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
University Clinical Centre of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo, Sarajevo, , Bosnia and Herzegovina
University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition, Tuzla, , Bosnia and Herzegovina
Herlev Hospital; Afdeling for Kræftbehandling, Herlev, , Denmark
Regionshospitalet Herning; Onkologisk afdeling, Herning, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R, Odense C, , Denmark
Kuopio University Hospital, Kuopio, , Finland
Oulu University Hospital; Gynaecology & Obstetrics Dept, Oulu, , Finland
Clinique Sainte Catherine; Hopital De Semaine, Avignon, , France
Clinique Tivoli; Sce Radiotherapie, Bordeaux, , France
Institut Bergonie; Gynecologie, Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie, Bordeaux, , France
Ch De Brive La Gaillarde; Radiotherapie Oncologie, Brive La Gaillarde, , France
Centre Francois Baclesse; Urologie Gynecologie, Caen, , France
Centre Jean Perrin; Hopital De Jour, Clermont Ferrand, , France
Hopital Louis Pasteur; Medecine B, Colmar, , France
Institut Daniel Hollard; Chimiotherapie Ambulatoire, Grenoble, , France
Centre Hospitalier Departemental Les Oudairies, La Roche Sur Yon, , France
Hopital La Source; Onco Med Hematologie Clinique, La Source, , France
Hopital Andre Mignot; Hematologie - Oncologie, Le Chesnay, , France
Centre Jean Bernard, Le Mans, , France
Centre Oscar Lambret; Cancerologie Gynecologique, Lille, , France
Clin Mut De Lyon Eugene Andre; Medecine 3 A, Lyon, , France
Hopital Layne; Medecine Ambulatoire, Mont-de-marsan, , France
Centre Val Aurelle Paul Lamarque; Medecine A1 A2, Montpellier, , France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE, Nancy, , France
Centre Catherine de Sienne; Chimiotherapie, Nantes, , France
Centre Antoine Lacassagne; Hopital De Jour A2, Nice, , France
Polyclinique Kenval ; Radiotherapie Oncologie, Nimes, , France
Hotel Dieu; Hematologie- Oncologie, Paris, , France
Institut Curie; Oncologie Medicale, Paris, , France
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset), Paris, , France
HOPITAL TENON; Cancerologie Medicale, Paris, , France
Clinique Francheville; Radiotherapie, Perigueux, , France
Institut Jean Godinot; Oncologie Medicale, Reims CEDEX, , France
Centre Henri Becquerel; Oncologie Medicale, Rouen, , France
Clinique Armoricaine Radiologie; Cons Externes, Saint Brieuc, , France
Ico Rene Gauducheau; Oncologie, Saint Herblain, , France
Centre Radiotherapie Etienne Dolet, Saint Nazaire, , France
Centre Rene Huguenin; Medecine B, St Cloud, , France
Hopital Civil; Expl Fonct Systeme Nerveux, Strasbourg, , France
Hopitaux Du Leman Site Thonon; Maternite Gynecologie, Thonon Les Bains, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Centre Alexis Vautrin; Oncologie Medicale, Vandoeuvre-les-nancy, , France
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe, Berlin, , Germany
Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie, Berlin, , Germany
Evangelischen Krankenhauses Düsseldorf; Frauenklinik, Düsseldorf, , Germany
Uni-Frauenklinik, Düsseldorf, , Germany
Universitätsklinikum Erlangen; Frauenklinik, Erlangen, , Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde, Essen, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe, Frankfurt, , Germany
Kath.Marienkrankenhaus gGmbH Frauenklinik, Hamburg, , Germany
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding, Hannover, , Germany
Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz, Hildesheim, , Germany
Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe, Kassel, , Germany
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe, Kiel, , Germany
HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe, Krefeld, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, , Germany
Universitätsklinikum Mannheim; Frauenklinik, Mannheim, , Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde, Muenchen, , Germany
Klinikum Nord Frauenklinik, Nürnberg, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe, Offenbach, , Germany
Oncologianova GmbH, Recklinghausen, , Germany
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt, Rostock, , Germany
Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe, Solingen, , Germany
Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum, Stuttgart, , Germany
Universitätsklinik Tübingen; Frauenklinik & Poliklinik, Tübingen, , Germany
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik, Ulm, , Germany
Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe, Wiesbaden, , Germany
University Hospital of Alexandra, Athens, , Greece
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano, Friuli-Venezia Giulia, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia, Udine, Friuli-Venezia Giulia, Italy
AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia, Roma, Lazio, Italy
Istituto Regina Elena; Oncologia Medica A, Roma, Lazio, Italy
Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia, Roma, Lazio, Italy
Ospedali Riuniti; Divisione Ostetricia e Ginecologia, Bergamo, Lombardia, Italy
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica, Mantova, Lombardia, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica, Milano, Lombardia, Italy
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases, Amersfoort, , Netherlands
Leyenburg Ziekenhuis; Internal Medecine, Den Haag, , Netherlands
Catharina ZKHS; Inwendige Geneeskunde Afd., Eindhoven, , Netherlands
Martini Ziekenhuis; Dept of Internal Medicine, Groningen, , Netherlands
Stichting St. Antonius Ziekenhuis, Nieuwegein, , Netherlands
Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd., Utrecht, , Netherlands
The Norvegian Radium Hospital Montebello; Dept of Oncology, Oslo, , Norway
St. Olavs Hospital; Kvinneklinikken, Trondheim, , Norway
IPO de Lisboa; Servico de Oncologia Medica, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia, Santander, Cantabria, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Hospital Son Llatzer; Servicio de Oncologia, Palma de Mallorca, Islas Baleares, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Hospital de Terrassa; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lerida, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia, Murcia, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Uni Hospital Linkoeping; Dept. of Oncology, Linköping, , Sweden
Norrlands Uni Hospital; Onkologi Avd., Umeå, , Sweden
Akademiska sjukhuset, Onkologkliniken, Uppsala, , Sweden
Örebro University Hospital; Department of Gynecologic Oncology, Örebro, , Sweden
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Ankara Baskent University Medicine Faculty; Gynaecology, Ankara, , Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology, Istanbul, , Turkey
Anadolu Health Center; Medical Oncology, Kocaeli, , Turkey
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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