AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
NCT ID: NCT00976911
Last Updated: 2022-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
361 participants
INTERVENTIONAL
2009-10-29
2014-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m\^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks \[q3w\]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
liposomal doxorubicin
40mg/m2 iv every 4 weeks
paclitaxel
80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
topotecan
4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
Chemotherapy + Bevacizumab
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
Bevacizumab
10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks
liposomal doxorubicin
40mg/m2 iv every 4 weeks
paclitaxel
80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
topotecan
4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
Interventions
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Bevacizumab
10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks
liposomal doxorubicin
40mg/m2 iv every 4 weeks
paclitaxel
80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
topotecan
4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* ovarian tumours with low malignant potential
* previous treatment with \>2 chemotherapy regimens
* prior radiotherapy to the pelvis or abdomen
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Institut Jules Bordet
Brussels, , 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
Nîmes, , 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
Périgueux, , France
Institut Jean Godinot; Oncologie Medicale
Reims, , France
Centre Henri Becquerel; Oncologie Medicale
Rouen, , France
Clinique Armoricaine Radiologie; Cons Externes
Saint-Brieuc, , France
Centre Rene Huguenin; Medecine B
Saint-Cloud, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Centre Radiotherapie Etienne Dolet
Saint-Nazaire, , 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
Vandœuvre-lès-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
Hanover, , 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
München, , Germany
Klinikum Nord Frauenklinik
Nuremberg, , 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
Rome, Lazio, Italy
Istituto Regina Elena; Oncologia Medica A
Rome, Lazio, Italy
Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia
Rome, Lazio, Italy
Ospedali Riuniti; Divisione Ostetricia e Ginecologia
Bergamo, Lombardy, Italy
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
Mantova, Lombardy, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
Milan, Lombardy, Italy
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
Amersfoort, , Netherlands
Catharina ZKHS; Inwendige Geneeskunde Afd.
Eindhoven, , Netherlands
Martini Ziekenhuis; Dept of Internal Medicine
Groningen, , Netherlands
Stichting St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Leyenburg Ziekenhuis; Internal Medecine
The Hague, , 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
Lisbon, , Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, , Portugal
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, Spain
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 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
Lleida, , 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
Örebro University Hospital; Department of Gynecologic Oncology
Örebro, , Sweden
Norrlands Uni Hospital; Onkologi Avd.
Umeå, , Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, , Sweden
Adana Baskent University Hospital; Medical Oncology
Adana, , Turkey (Türkiye)
Ankara Baskent University Medicine Faculty; Gynaecology
Ankara, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
Anadolu Health Center; Medical Oncology
Kocaeli, , Turkey (Türkiye)
Countries
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References
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Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Roncolato FT, Gibbs E, Lee CK, Asher R, Davies LC, Gebski VJ, Friedlander M, Hilpert F, Wenzel L, Stockler MR, King M, Pujade-Lauraine E. Quality of life predicts overall survival in women with platinum-resistant ovarian cancer: an AURELIA substudy. Ann Oncol. 2017 Aug 1;28(8):1849-1855. doi: 10.1093/annonc/mdx229.
Bamias A, Gibbs E, Khoon Lee C, Davies L, Dimopoulos M, Zagouri F, Veillard AS, Kosse J, Santaballa A, Mirza MR, Tabaro G, Vergote I, Bloemendal H, Lykka M, Floquet A, Gebski V, Pujade-Lauraine E. Bevacizumab with or after chemotherapy for platinum-resistant recurrent ovarian cancer: exploratory analyses of the AURELIA trial. Ann Oncol. 2017 Aug 1;28(8):1842-1848. doi: 10.1093/annonc/mdx228.
Sorio R, Roemer-Becuwe C, Hilpert F, Gibbs E, Garcia Y, Kaern J, Huizing M, Witteveen P, Zagouri F, Coeffic D, Luck HJ, Gonzalez-Martin A, Kristensen G, Levache CB, Lee CK, Gebski V, Pujade-Lauraine E; AURELIA Investigators. Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial. Gynecol Oncol. 2017 Jan;144(1):65-71. doi: 10.1016/j.ygyno.2016.11.006. Epub 2016 Nov 18.
Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31.
Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17.
Other Identifiers
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2009-011400-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO22224
Identifier Type: -
Identifier Source: org_study_id
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