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Ovarian CancerPhase 3NCT00976911

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

A Phase 3 study testing Bevacizumab, liposomal doxorubicin and paclitaxel in people with Ovarian Cancer, run by Hoffmann-La Roche at 117 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Bevacizumab, liposomal doxorubicin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
361 participants
Where
117 sitesin 14 countries
Study dates
29 Oct 2009to 9 Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

117 sites in 14 countries.

117 sites in 14 countries

France36 sites

  • Clinique Sainte Catherine; Hopital De Semaine

    Avignon, 84918

  • Clinique Tivoli; Sce Radiotherapie

    Bordeaux, 33000

  • Institut Bergonie; Gynecologie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077

  • Ch De Brive La Gaillarde; Radiotherapie Oncologie

    Brive-la-Gaillarde, 19312

  • Centre Francois Baclesse; Urologie Gynecologie

    Caen, 14076

  • Centre Jean Perrin; Hopital De Jour

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur; Medecine B

    Colmar, 68024

  • Institut Daniel Hollard; Chimiotherapie Ambulatoire

    Grenoble, 38000

  • Centre Hospitalier Departemental Les Oudairies

    La Roche-sur-Yon, 85925

  • Hopital La Source; Onco Med Hematologie Clinique

    La Source, 45100

  • Hopital Andre Mignot; Hematologie - Oncologie

    Le Chesnay, 78157

  • Centre Jean Bernard

    Le Mans, 72015

  • Centre Oscar Lambret; Cancerologie Gynecologique

    Lille, 59020

  • Clin Mut De Lyon Eugene Andre; Medecine 3 A

    Lyon, 69424

  • Hopital Layne; Medecine Ambulatoire

    Mont-de-Marsan, 40024

  • Centre Val Aurelle Paul Lamarque; Medecine A1 A2

    Montpellier, 34298

  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

    Nancy, 54100

  • Centre Catherine de Sienne; Chimiotherapie

    Nantes, 44202

  • Centre Antoine Lacassagne; Hopital De Jour A2

    Nice, 06189

  • Polyclinique Kenval ; Radiotherapie Oncologie

    Nîmes, 30900

  • Hotel Dieu; Hematologie- Oncologie

    Paris, 75181

  • Institut Curie; Oncologie Medicale

    Paris, 75231

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

    Paris, 75475

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Clinique Francheville; Radiotherapie

    Périgueux, 24000

  • Institut Jean Godinot; Oncologie Medicale

    Reims, 51056

  • Centre Henri Becquerel; Oncologie Medicale

    Rouen, 76038

  • Clinique Armoricaine Radiologie; Cons Externes

    Saint-Brieuc, 22015

  • Centre Rene Huguenin; Medecine B

    Saint-Cloud, 92210

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Centre Radiotherapie Etienne Dolet

    Saint-Nazaire, 44600

  • Hopital Civil; Expl Fonct Systeme Nerveux

    Strasbourg, 67091

  • Hopitaux Du Leman Site Thonon; Maternite Gynecologie

    Thonon-les-Bains, 74203

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandœuvre-lès-Nancy, 54519

Other trials in France

Germany26 sites

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

    Berlin, 13125

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

    Berlin, 13353

  • Evangelischen Krankenhauses Düsseldorf; Frauenklinik

    Düsseldorf, 40217

  • Uni-Frauenklinik

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen; Frauenklinik

    Erlangen, 91054

  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

    Essen, 45122

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

    Essen, 45136

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

    Frankfurt, 60596

  • Kath.Marienkrankenhaus gGmbH Frauenklinik

    Hamburg, 22087

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

    Hanover, 30177

  • Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz

    Hildesheim, 31134

  • Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

    Kassel, 34125

  • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

    Kiel, 24105

  • HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe

    Krefeld, 47805

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

    Lübeck, 23538

  • Universitätsklinikum Mannheim; Frauenklinik

    Mannheim, 68167

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

    München, 81377

  • Klinikum Nord Frauenklinik

    Nuremberg, 90419

  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

    Offenbach, 63069

  • Oncologianova GmbH

    Recklinghausen, 45659

  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

    Rostock, 18059

  • Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe

    Solingen, 42653

  • Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum

    Stuttgart, 70376

  • Universitätsklinik Tübingen; Frauenklinik & Poliklinik

    Tübingen, 72076

  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

    Ulm, 89075

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

    Wiesbaden, 65199

Other trials in Germany

Spain15 sites

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

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

    Barcelona, 08041

  • Hospital de Terrassa; Servicio de Oncologia

    Barcelona, 08227

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

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

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

    Madrid, 28033

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

    Madrid, 28050

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

    Murcia, 30008

  • Hospital Son Llatzer; Servicio de Oncologia

    Palma de Mallorca, Balearic Islands, 07198

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

    Santander, Cantabria, 39008

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Italy8 sites

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

    Aviano, Friuli Venezia Giulia, 33081

  • Ospedali Riuniti; Divisione Ostetricia e Ginecologia

    Bergamo, Lombardy, 24128

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

    Mantua, Lombardy, 46100

  • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

    Milan, Lombardy, 20133

  • AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia

    Rome, Lazio, 00161

  • Istituto Regina Elena; Oncologia Medica A

    Rome, Lazio, 00168

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

    Rome, Lazio, 00186

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

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Netherlands6 sites

  • Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases

    Amersfoort, 3818 ES

  • Catharina ZKHS; Inwendige Geneeskunde Afd.

    Eindhoven, 5623 EJ

  • Martini Ziekenhuis; Dept of Internal Medicine

    Groningen, 9728 NT

  • Stichting St. Antonius Ziekenhuis

    Nieuwegein, 3430 EM

  • Leyenburg Ziekenhuis; Internal Medecine

    The Hague, 2545 CH

  • Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium4 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Antwerpen

    Edegem, 2650

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Clinique Ste-Elisabeth

    Namur, 5000

Other trials in Belgium

Denmark4 sites

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730

  • Regionshospitalet Herning; Onkologisk afdeling

    Herning, 7400

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

Other trials in Denmark

Sweden4 sites

  • Uni Hospital Linkoeping; Dept. of Oncology

    Linköping, 58185

  • Örebro University Hospital; Department of Gynecologic Oncology

    Örebro, 70185

  • Norrlands Uni Hospital; Onkologi Avd.

    Umeå, 901 85

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 751 85

Other trials in Sweden

Turkey (Türkiye)4 sites

  • Adana Baskent University Hospital; Medical Oncology

    Adana, 01120

  • Ankara Baskent University Medicine Faculty; Gynaecology

    Ankara, 06500

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

  • Anadolu Health Center; Medical Oncology

    Kocaeli, 41400

Other trials in Turkey (Türkiye)

Bosnia and Herzegovina3 sites

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 7100

  • University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Finland2 sites

  • Kuopio University Hospital

    Kuopio, 70211

  • Oulu University Hospital; Gynaecology & Obstetrics Dept

    Oulu, 90220

Other trials in Finland

Norway2 sites

  • The Norvegian Radium Hospital Montebello; Dept of Oncology

    Oslo, 0379

  • St. Olavs Hospital; Kvinneklinikken

    Trondheim, 7006

Other trials in Norway

Portugal2 sites

  • IPO de Lisboa; Servico de Oncologia Medica

    Lisbon, 1099-023

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Greece1 site

  • University Hospital of Alexandra

    Athens, 11528

Other trials in Greece

About this study

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

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.

Conditions
Ovarian Cancer
Being tested
Bevacizumab, liposomal doxorubicin, paclitaxel, topotecan
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

  • liposomal doxorubicinDrug

    40mg/m2 iv every 4 weeks

  • paclitaxelDrug

    80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle

  • topotecanDrug

    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

Study groups in NCT00976911
Study groupRoleWhat they receive
ChemotherapyActive comparatorParticipants 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.
Receives: Drug: liposomal doxorubicin; Drug: paclitaxel; Drug: topotecan
Chemotherapy + BevacizumabExperimentalParticipants 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.
Receives: Drug: Bevacizumab; Drug: liposomal doxorubicin; Drug: paclitaxel; Drug: topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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 outcomes (5)

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. Percentage of Participants Who Died (Data Cutoff 25 January 2013)

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2009 (estimated)
  2. Study start29 Oct 2009
  3. Primary completion9 Jul 2014
  4. Study completion9 Jul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
361 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976911
Sponsor's protocol ID
MO22224
Other IDs
2009-011400-33, 2009
Status last verified
May 2022
First submitted
14 Sep 2009
Last updated
21 Jun 2022

Publications

  • 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.

    PubMed 37407274

  • 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.

    PubMed 37185961

  • 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.

    PubMed 28595285

  • 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.

    PubMed 28481967

  • 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.

    PubMed 27871723

  • 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.

    PubMed 24687829

  • 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.

    PubMed 24637997

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, liposomal doxorubicin and paclitaxel in people with Ovarian Cancer, run by Hoffmann-La Roche at 117 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in France, Germany, Spain, Italy, Netherlands and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00976911, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.

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