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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: liposomal doxorubicin; Drug: paclitaxel; Drug: topotecan; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1000
    • Institut Jules Bordet
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Namur, Belgium, 5000
    • Clinique Ste-Elisabeth
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Centre of the Republic of Srpska
  • Sarajevo, Bosnia and Herzegovina, 7100
    • Clinic of Oncology, University Clinical Center Sarajevo
  • Tuzla, Bosnia and Herzegovina, 75000
    • University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition
• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital; Afdeling for Kræftbehandling
  • Herning, Denmark, 7400
    • Regionshospitalet Herning; Onkologisk afdeling
  • København Ø, Denmark, 2100
    • Rigshospitalet; Onkologisk Klinik
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Onkologisk Afdeling R
• Finland
  • Kuopio, Finland, 70211
    • Kuopio University Hospital
  • Oulu, Finland, 90220
    • Oulu University Hospital; Gynaecology & Obstetrics Dept
• France
  • Avignon, France, 84918
    • Clinique Sainte Catherine; Hopital De Semaine
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
  • Bordeaux, France, 33000
    • Clinique Tivoli; Sce Radiotherapie
  • Bordeaux, France, 33076
    • Institut Bergonie; Gynecologie
  • Brive La Gaillarde, France, 19312
    • Ch De Brive La Gaillarde; Radiotherapie Oncologie
  • Caen, France, 14076
    • Centre Francois Baclesse; Urologie Gynecologie
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin; Hopital De Jour
  • Colmar, France, 68024
    • Hopital Louis Pasteur; Medecine B
  • Grenoble, France, 38000
    • Institut Daniel Hollard; Chimiotherapie Ambulatoire
  • La Roche Sur Yon, France, 85925
    • Centre Hospitalier Départemental Les Oudairies
  • La Source, France, 45100
    • Hopital La Source; Onco Med Hematologie Clinique
  • Le Chesnay, France, 78157
    • Hopital Andre Mignot; Hematologie - Oncologie
  • Le Mans, France, 72015
    • Centre Jean Bernard
  • Lille, France, 59020
    • Centre Oscar Lambret; Cancerologie Gynecologique
  • Lyon, France, 69424
    • Clin Mut De Lyon Eugene Andre; Medecine 3 A
  • Mont-de-marsan, France, 40024
    • Hopital Layne; Medecine Ambulatoire
  • Montpellier, France, 34298
    • Centre Val Aurelle Paul Lamarque; Medecine A1 A2
  • Nancy, France, 54100
    • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
  • Nantes, France, 44202
    • Centre Catherine de Sienne; Chimiotherapie
  • Nice, France, 06189
    • Centre Antoine Lacassagne; Hopital De Jour A2
  • Nimes, France, 30900
    • Polyclinique Kenval ; Radiotherapie Oncologie
  • Paris, France, 75231
    • Institut Curie; Oncologie Medicale
  • Paris, France, 75970
    • HOPITAL TENON; Cancerologie Medicale
  • Paris, France, 75475
    • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
  • Paris, France, 75181
    • Hotel Dieu; Hematologie- Oncologie
  • Perigueux, France, 24000
    • Clinique Francheville; Radiotherapie
  • Reims CEDEX, France, 51056
    • Institut Jean Godinot; Oncologie Medicale
  • Rouen, France, 76038
    • Centre Henri Becquerel; Oncologie Medicale
  • Saint Brieuc, France, 22015
    • Clinique Armoricaine Radiologie; Cons Externes
  • Saint Herblain, France, 44805
    • Ico Rene Gauducheau; Oncologie
  • Saint Nazaire, France, 44600
    • Centre Radiotherapie Etienne Dolet
  • St Cloud, France, 92210
    • Centre Rene Huguenin; Medecine B
  • Strasbourg, France, 67091
    • Hopital Civil; Expl Fonct Systeme Nerveux
  • Thonon Les Bains, France, 74203
    • Hopitaux Du Leman Site Thonon; Maternite Gynecologie
  • Toulouse, France, 31059
    • Institut Claudius Regaud; Departement Oncologie Medicale
  • Vandoeuvre-les-nancy, France, 54519
    • Centre Alexis Vautrin; Oncologie Medicale
• Germany
  • Berlin, Germany, 13125
    • HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
  • Berlin, Germany, 13353
    • Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
  • Düsseldorf, Germany, 40217
    • Evangelischen Krankenhauses Düsseldorf; Frauenklinik
  • Düsseldorf, Germany, 40225
    • Uni-Frauenklinik
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen; Frauenklinik
  • Essen, Germany, 45136
    • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Essen, Germany, 45122
    • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
  • Frankfurt, Germany, 60596
    • Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
  • Hamburg, Germany, 22087
    • Kath.Marienkrankenhaus gGmbH Frauenklinik
  • Hannover, Germany, 30177
    • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
  • Hildesheim, Germany, 31134
    • Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
  • Kassel, Germany, 34125
    • Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
  • Kiel, Germany, 24105
    • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
  • Krefeld, Germany, 47805
    • HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim; Frauenklinik
  • Muenchen, Germany, 81377
    • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
  • Nürnberg, Germany, 90419
    • Klinikum Nord Frauenklinik
  • Offenbach, Germany, 63069
    • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
  • Recklinghausen, Germany, 45659
    • Oncologianova GmbH
  • Rostock, Germany, 18059
    • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
  • Solingen, Germany, 42653
    • Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum
  • Tübingen, Germany, 72076
    • Universitätsklinik Tübingen; Frauenklinik & Poliklinik
  • Ulm, Germany, 89075
    • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
  • Wiesbaden, Germany, 65199
    • Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe
• Greece
  • Athens, Greece, 11528
    • University Hospital of Alexandra
• Italy
  • Friuli-Venezia Giulia
    • Aviano, Friuli-Venezia Giulia, Italy, 33081
      • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Istituto Regina Elena; Oncologia Medica A
    • Roma, Lazio, Italy, 00161
      • AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia
    • Roma, Lazio, Italy, 00186
      • Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia
  • Lombardia
    • Bergamo, Lombardia, Italy, 24128
      • Ospedali Riuniti; Divisione Ostetricia e Ginecologia
    • Mantova, Lombardia, Italy, 46100
      • Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
    • Milano, Lombardia, Italy, 20133
      • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
• Netherlands
  • Amersfoort, Netherlands, 3818 ES
    • Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
  • Den Haag, Netherlands, 2545 CH
    • Leyenburg Ziekenhuis; Internal Medecine
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina ZKHS; Inwendige Geneeskunde Afd.
  • Groningen, Netherlands, 9728 NT
    • Martini Ziekenhuis; Dept of Internal Medicine
  • Nieuwegein, Netherlands, 3430 EM
    • Stichting St. Antonius ziekenhuis
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
• Norway
  • Oslo, Norway, 0379
    • The Norvegian Radium Hospital Montebello; Dept of Oncology
  • Trondheim, Norway, 7006
    • St. Olavs Hospital; Kvinneklinikken
• Portugal
  • Lisboa, Portugal, 1099-023
    • IPO de Lisboa; Servico de Oncologia Medica
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Spain
  • Barcelona, Spain, 08035
    • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Barcelona, Spain, 08227
    • Hospital de Terrassa; Servicio de Oncologia
  • Lerida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid, Spain, 28033
    • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  • Madrid, Spain, 28050
    • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
  • Murcia, Spain, 30008
    • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe; Servicio de Oncologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Barcelona
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Hospital Son Llatzer; Servicio de Oncologia
• Sweden
  • Linköping, Sweden, 58185
    • Uni Hospital Linkoeping; Dept. of Oncology
  • Umeå, Sweden, 901 85
    • Norrlands Uni Hospital; Onkologi Avd.
  • Uppsala, Sweden, 751 85
    • Akademiska sjukhuset, Onkologkliniken
  • Örebro, Sweden, 70185
    • Örebro University Hospital; Department of Gynecologic Oncology
• Turkey
  • Adana, Turkey, 01120
    • Adana Baskent University Hospital; Medical Oncology
  • Ankara, Turkey, 06500
    • Ankara Baskent University Medicine Faculty; Gynaecology
  • Istanbul, Turkey, 34300
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Kocaeli, Turkey, 41400
    • Anadolu Health Center; Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: liposomal doxorubicin; 40mg/m2 iv every 4 weeks; Drug: paclitaxel; 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle; Drug: 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
Experimental: 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.	Drug: liposomal doxorubicin; 40mg/m2 iv every 4 weeks; Drug: paclitaxel; 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle; Drug: 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; Drug: Bevacizumab; 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)	Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.	Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
Progression Free Survival (PFS; Data Cutoff 14 November 2011)	PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.	Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)	Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.	Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
Duration of Objective Response (Data Cutoff 14 November 2011)	For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan-Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley.	Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
Percentage of Participants Who Died (Data Cutoff 25 January 2013)		Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013
Overall Survival (Data Cutoff 25 January 2013)	Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley.	Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)	The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.	Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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. Erratum In: J Clin Oncol. 2014 Dec 10;32(35):4025.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2009
• Primary Completion (Actual): July 9, 2014
• Study Completion (Actual): July 9, 2014

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 14, 2009
• First Posted (Estimate): September 15, 2009

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antibiotics, Antineoplastic; Topoisomerase I Inhibitors; Paclitaxel; Bevacizumab; Doxorubicin; Liposomal doxorubicin; Topotecan
• Other Study ID Numbers: MO22224; 2009-011400-33 (EudraCT Number)