AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Last updated: May 5, 2022
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Ovarian Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT00976911
MO22224
2009-011400-33
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • female patients, >/=18 years of age
  • epithelial ovarian, fallopian tube or primary peritoneal cancer
  • platinum-resistant disease (disease progression within <6 months of platinum therapy)
  • EOCG performance status of 0-2

Exclusion

Exclusion Criteria:

  • non-epithelial tumours
  • ovarian tumours with low malignant potential
  • previous treatment with >2 chemotherapy regimens
  • prior radiotherapy to the pelvis or abdomen

Study Design

Total Participants: 361
Study Start date:
October 29, 2009
Estimated Completion Date:
July 09, 2014

Connect with a study center

  • Institut Jules Bordet

    Bruxelles, 1000
    Belgium

    Site Not Available

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Clinique Ste-Elisabeth

    Namur, 5000
    Belgium

    Site Not Available

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000
    Bosnia and Herzegovina

    Site Not Available

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 7100
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition

    Tuzla, 75000
    Bosnia and Herzegovina

    Site Not Available

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730
    Denmark

    Site Not Available

  • Regionshospitalet Herning; Onkologisk afdeling

    Herning, 7400
    Denmark

    Site Not Available

  • empty

    Hillerød, 3400
    Denmark

    Site Not Available

  • empty

    København, 2100
    Denmark

    Site Not Available

  • empty

    København, 2100
    Denmark

    Site Not Available

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100
    Denmark

    Site Not Available

  • empty

    Odense, 5000
    Denmark

    Site Not Available

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000
    Denmark

    Site Not Available

  • Kuopio University Hospital

    Kuopio, 70211
    Finland

    Site Not Available

  • Oulu University Hospital; Gynaecology & Obstetrics Dept

    Oulu, 90220
    Finland

    Site Not Available

  • Clinique Sainte Catherine; Hopital De Semaine

    Avignon, 84918
    France

    Site Not Available

  • Clinique Tivoli; Sce Radiotherapie

    Bordeaux, 33000
    France

    Site Not Available

  • Institut Bergonie; Gynecologie

    Bordeaux, 33076
    France

    Site Not Available

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077
    France

    Site Not Available

  • empty

    Brive, 19312
    France

    Site Not Available

  • Ch De Brive La Gaillarde; Radiotherapie Oncologie

    Brive La Gaillarde, 19312
    France

    Site Not Available

  • Centre Francois Baclesse; Urologie Gynecologie

    Caen, 14076
    France

    Site Not Available

  • Centre Jean Perrin; Hopital De Jour

    Clermont Ferrand, 63011
    France

    Site Not Available

  • empty

    Clermont-ferrand, 63011
    France

    Site Not Available

  • Hopital Louis Pasteur; Medecine B

    Colmar, 68024
    France

    Site Not Available

  • Institut Daniel Hollard; Chimiotherapie Ambulatoire

    Grenoble, 38000
    France

    Site Not Available

  • Centre Hospitalier Departemental Les Oudairies

    La Roche Sur Yon, 85925
    France

    Site Not Available

  • Hopital La Source; Onco Med Hematologie Clinique

    La Source, 45100
    France

    Site Not Available

  • Hopital Andre Mignot; Hematologie - Oncologie

    Le Chesnay, 78157
    France

    Site Not Available

  • Centre Jean Bernard

    Le Mans, 72015
    France

    Site Not Available

  • Centre Oscar Lambret; Cancerologie Gynecologique

    Lille, 59020
    France

    Site Not Available

  • Clin Mut De Lyon Eugene Andre; Medecine 3 A

    Lyon, 69424
    France

    Site Not Available

  • empty

    Metz Tessy, 74370
    France

    Site Not Available

  • Hopital Layne; Medecine Ambulatoire

    Mont-de-marsan, 40024
    France

    Site Not Available

  • Centre Val Aurelle Paul Lamarque; Medecine A1 A2

    Montpellier, 34298
    France

    Site Not Available

  • empty

    Mougins, 06250
    France

    Site Not Available

  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

    Nancy, 54100
    France

    Site Not Available

  • Centre Catherine de Sienne; Chimiotherapie

    Nantes, 44202
    France

    Site Not Available

  • Centre Antoine Lacassagne; Hopital De Jour A2

    Nice, 06189
    France

    Site Not Available

  • Polyclinique Kenval ; Radiotherapie Oncologie

    Nimes, 30900
    France

    Site Not Available

  • empty

    Orleans, 45100
    France

    Site Not Available

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970
    France

    Site Not Available

  • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

    Paris, 75475
    France

    Site Not Available

  • Hotel Dieu; Hematologie- Oncologie

    Paris, 75181
    France

    Site Not Available

  • Institut Curie; Oncologie Medicale

    Paris, 75231
    France

    Site Not Available

  • Clinique Francheville; Radiotherapie

    Perigueux, 24000
    France

    Site Not Available

  • empty

    Pringy, 74370
    France

    Site Not Available

  • empty

    Reims, 51056
    France

    Site Not Available

  • Institut Jean Godinot; Oncologie Medicale

    Reims CEDEX, 51056
    France

    Site Not Available

  • Centre Henri Becquerel; Oncologie Medicale

    Rouen, 76038
    France

    Site Not Available

  • empty

    Rouen Cedex, 76038
    France

    Site Not Available

  • Clinique Armoricaine Radiologie; Cons Externes

    Saint Brieuc, 22015
    France

    Site Not Available

  • Ico Rene Gauducheau; Oncologie

    Saint Herblain, 44805
    France

    Site Not Available

  • Centre Radiotherapie Etienne Dolet

    Saint Nazaire, 44600
    France

    Site Not Available

  • empty

    Saint-cloud, 92210
    France

    Site Not Available

  • Centre Rene Huguenin; Medecine B

    St Cloud, 92210
    France

    Site Not Available

  • empty

    St Herblain, 44805
    France

    Site Not Available

  • Hopital Civil; Expl Fonct Systeme Nerveux

    Strasbourg, 67091
    France

    Site Not Available

  • Hopitaux Du Leman Site Thonon; Maternite Gynecologie

    Thonon Les Bains, 74203
    France

    Site Not Available

  • empty

    Thonon-les-bains, 74203
    France

    Site Not Available

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059
    France

    Site Not Available

  • empty

    Vandoeuvre Les Nancy, 54511
    France

    Site Not Available

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandoeuvre-les-nancy, 54519
    France

    Site Not Available

  • Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

    Berlin, 13353
    Germany

    Site Not Available

  • HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

    Berlin, 13125
    Germany

    Site Not Available

  • empty

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Evangelischen Krankenhauses Düsseldorf; Frauenklinik

    Düsseldorf, 40217
    Germany

    Site Not Available

  • Uni-Frauenklinik

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen; Frauenklinik

    Erlangen, 91054
    Germany

    Site Not Available

  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

    Essen, 45136
    Germany

    Site Not Available

  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

    Essen, 45122
    Germany

    Site Not Available

  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

    Frankfurt, 60596
    Germany

    Site Not Available

  • Kath.Marienkrankenhaus gGmbH Frauenklinik

    Hamburg, 22087
    Germany

    Site Not Available

  • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

    Hannover, 30177
    Germany

    Site Not Available

  • Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz

    Hildesheim, 31134
    Germany

    Site Not Available

  • Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

    Kassel, 34125
    Germany

    Site Not Available

  • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

    Kiel, 24105
    Germany

    Site Not Available

  • HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe

    Krefeld, 47805
    Germany

    Site Not Available

  • empty

    Lübeck, 23562
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538
    Germany

    Site Not Available

  • Universitätsklinikum Mannheim; Frauenklinik

    Mannheim, 68167
    Germany

    Site Not Available

  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

    Muenchen, 81377
    Germany

    Site Not Available

  • empty

    München, 81377
    Germany

    Site Not Available

  • empty

    München, 81377
    Germany

    Site Not Available

  • empty

    Nuernberg, 90419
    Germany

    Site Not Available

  • Klinikum Nord Frauenklinik

    Nürnberg, 90419
    Germany

    Site Not Available

  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

    Offenbach, 63069
    Germany

    Site Not Available

  • Oncologianova GmbH

    Recklinghausen, 45659
    Germany

    Site Not Available

  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

    Rostock, 18059
    Germany

    Site Not Available

  • Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe

    Solingen, 42653
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum

    Stuttgart, 70376
    Germany

    Site Not Available

  • empty

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinik Tübingen; Frauenklinik & Poliklinik

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

    Ulm, 89075
    Germany

    Site Not Available

  • Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe

    Wiesbaden, 65199
    Germany

    Site Not Available

  • University Hospital of Alexandra

    Athens, 11528
    Greece

    Site Not Available

  • empty

    Thessaloniki, 56429
    Greece

    Site Not Available

  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

    Aviano, Friuli-Venezia Giulia 33081
    Italy

    Site Not Available

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

    Udine, Friuli-Venezia Giulia 33100
    Italy

    Site Not Available

  • AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia

    Roma, Lazio 00161
    Italy

    Site Not Available

  • Istituto Regina Elena; Oncologia Medica A

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia

    Roma, Lazio 00186
    Italy

    Site Not Available

  • Ospedali Riuniti; Divisione Ostetricia e Ginecologia

    Bergamo, Lombardia 24128
    Italy

    Site Not Available

  • Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

    Mantova, Lombardia 46100
    Italy

    Site Not Available

  • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • empty

    Bologna, 40138
    Italy

    Site Not Available

  • empty

    Palermo, 90146
    Italy

    Site Not Available

  • Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases

    Amersfoort, 3818 ES
    Netherlands

    Site Not Available

  • Leyenburg Ziekenhuis; Internal Medecine

    Den Haag, 2545 CH
    Netherlands

    Site Not Available

  • Catharina ZKHS; Inwendige Geneeskunde Afd.

    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • Martini Ziekenhuis; Dept of Internal Medicine

    Groningen, 9728 NT
    Netherlands

    Site Not Available

  • Stichting St. Antonius Ziekenhuis

    Nieuwegein, 3430 EM
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • empty

    Bergen, 5021
    Norway

    Site Not Available

  • The Norvegian Radium Hospital Montebello; Dept of Oncology

    Oslo, 0379
    Norway

    Site Not Available

  • St. Olavs Hospital; Kvinneklinikken

    Trondheim, 7006
    Norway

    Site Not Available

  • IPO de Lisboa; Servico de Oncologia Medica

    Lisboa, 1099-023
    Portugal

    Site Not Available

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072
    Portugal

    Site Not Available

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona 8208
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba 14004
    Spain

    Site Not Available

  • Hospital Son Llatzer; Servicio de Oncologia

    Palma de Mallorca, Islas Baleares 07198
    Spain

    Site Not Available

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de Terrassa; Servicio de Oncologia

    Barcelona, 08227
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

    Barcelona, 08041
    Spain

    Site Not Available

  • empty

    Cordoba, 14004
    Spain

    Site Not Available

  • empty

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

    Lerida, 25198
    Spain

    Site Not Available

  • empty

    Lleida, 25198
    Spain

    Site Not Available

  • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

    Madrid, 28050
    Spain

    Site Not Available

  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

    Madrid, 28033
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

    Murcia, 30008
    Spain

    Site Not Available

  • empty

    Sabadell, Barcelona, 08208
    Spain

    Site Not Available

  • empty

    Terrassa, 08227
    Spain

    Site Not Available

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026
    Spain

    Site Not Available

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009
    Spain

    Site Not Available

  • empty

    Linkoeping, 58185
    Sweden

    Site Not Available

  • Uni Hospital Linkoeping; Dept. of Oncology

    Linköping, 58185
    Sweden

    Site Not Available

  • empty

    Umea, 90185
    Sweden

    Site Not Available

  • Norrlands Uni Hospital; Onkologi Avd.

    Umeå, 901 85
    Sweden

    Site Not Available

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 751 85
    Sweden

    Site Not Available

  • empty

    Örebro, 70185
    Sweden

    Site Not Available

  • Örebro University Hospital; Department of Gynecologic Oncology

    Örebro, 70185
    Sweden

    Site Not Available

  • Adana Baskent University Hospital; Medical Oncology

    Adana, 01120
    Turkey

    Site Not Available

  • Ankara Baskent University Medicine Faculty; Gynaecology

    Ankara, 06500
    Turkey

    Site Not Available

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300
    Turkey

    Site Not Available

  • Anadolu Health Center; Medical Oncology

    Kocaeli, 41400
    Turkey

    Site Not Available

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