Clinical trial NCT00976911: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-09-15
Enrollment: 361
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)
timeFrame: 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
measure: Progression Free Survival (PFS; Data Cutoff 14 November 2011)
timeFrame: 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:
measure: 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)
timeFrame: 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
measure: Duration of Objective Response (Data Cutoff 14 November 2011)
timeFrame: 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
measure: Percentage of Participants Who Died (Data Cutoff 25 January 2013)
timeFrame: 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
measure: Overall Survival (Data Cutoff 25 January 2013)
timeFrame: 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
measure: 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)
timeFrame: Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition
city: Herlev
country: Denmark
facility: Herlev Hospital; Afdeling for Kræftbehandling
city: Herning
country: Denmark
facility: Regionshospitalet Herning; Onkologisk afdeling
city: København Ø
country: Denmark
facility: Rigshospitalet; Onkologisk Klinik
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital; Gynaecology & Obstetrics Dept
city: Avignon
country: France
facility: Clinique Sainte Catherine; Hopital De Semaine
city: Bordeaux
country: France
facility: Clinique Tivoli; Sce Radiotherapie
city: Bordeaux
country: France
facility: Institut Bergonie; Gynecologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
city: Brive La Gaillarde
country: France
facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie
city: Caen
country: France
facility: Centre Francois Baclesse; Urologie Gynecologie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Hopital De Jour
city: Colmar
country: France
facility: Hopital Louis Pasteur; Medecine B
city: Grenoble
country: France
facility: Institut Daniel Hollard; Chimiotherapie Ambulatoire
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental Les Oudairies
city: La Source
country: France
facility: Hopital La Source; Onco Med Hematologie Clinique
city: Le Chesnay
country: France
facility: Hopital Andre Mignot; Hematologie - Oncologie
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Lille
country: France
facility: Centre Oscar Lambret; Cancerologie Gynecologique
city: Lyon
country: France
facility: Clin Mut De Lyon Eugene Andre; Medecine 3 A
city: Mont-de-marsan
country: France
facility: Hopital Layne; Medecine Ambulatoire
city: Montpellier
country: France
facility: Centre Val Aurelle Paul Lamarque; Medecine A1 A2
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Nantes
country: France
facility: Centre Catherine de Sienne; Chimiotherapie
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Nimes
country: France
facility: Polyclinique Kenval ; Radiotherapie Oncologie
city: Paris
country: France
facility: Hotel Dieu; Hematologie- Oncologie
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Paris
country: France
facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Perigueux
country: France
facility: Clinique Francheville; Radiotherapie
city: Reims CEDEX
country: France
facility: Institut Jean Godinot; Oncologie Medicale
city: Rouen
country: France
facility: Centre Henri Becquerel; Oncologie Medicale
city: Saint Brieuc
country: France
facility: Clinique Armoricaine Radiologie; Cons Externes
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau; Oncologie
city: Saint Nazaire
country: France
facility: Centre Radiotherapie Etienne Dolet
city: St Cloud
country: France
facility: Centre Rene Huguenin; Medecine B
city: Strasbourg
country: France
facility: Hopital Civil; Expl Fonct Systeme Nerveux
city: Thonon Les Bains
country: France
facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Vandoeuvre-les-nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
city: Berlin
country: Germany
facility: Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
city: Düsseldorf
country: Germany
facility: Evangelischen Krankenhauses Düsseldorf; Frauenklinik
city: Düsseldorf
country: Germany
facility: Uni-Frauenklinik
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Frauenklinik
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
city: Essen
country: Germany
facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
city: Hamburg
country: Germany
facility: Kath.Marienkrankenhaus gGmbH Frauenklinik
city: Hannover
country: Germany
facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
city: Hildesheim
country: Germany
facility: Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
city: Kiel
country: Germany
facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
city: Krefeld
country: Germany
facility: HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim; Frauenklinik
city: Muenchen
country: Germany
facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
city: Nürnberg
country: Germany
facility: Klinikum Nord Frauenklinik
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Rostock
country: Germany
facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
city: Solingen
country: Germany
facility: Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe
city: Athens
country: Greece
facility: University Hospital of Alexandra
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
state: Friuli-Venezia Giulia
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia
state: Lazio
city: Roma
country: Italy
facility: Istituto Regina Elena; Oncologia Medica A
state: Lazio
city: Roma
country: Italy
facility: Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia
state: Lazio
city: Bergamo
country: Italy
facility: Ospedali Riuniti; Divisione Ostetricia e Ginecologia
state: Lombardia
city: Mantova
country: Italy
facility: Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
state: Lombardia
city: Amersfoort
country: Netherlands
facility: Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
city: Den Haag
country: Netherlands
facility: Leyenburg Ziekenhuis; Internal Medecine
city: Eindhoven
country: Netherlands
facility: Catharina ZKHS; Inwendige Geneeskunde Afd.
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis; Dept of Internal Medicine
city: Nieuwegein
country: Netherlands
facility: Stichting St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
city: Oslo
country: Norway
facility: The Norvegian Radium Hospital Montebello; Dept of Oncology
city: Trondheim
country: Norway
facility: St. Olavs Hospital; Kvinneklinikken
city: Lisboa
country: Portugal
facility: IPO de Lisboa; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer; Servicio de Oncologia
state: Islas Baleares
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital de Terrassa; Servicio de Oncologia
city: Lerida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
city: Murcia
country: Spain
facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Linköping
country: Sweden
facility: Uni Hospital Linkoeping; Dept. of Oncology
city: Umeå
country: Sweden
facility: Norrlands Uni Hospital; Onkologi Avd.
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Onkologkliniken
city: Örebro
country: Sweden
facility: Örebro University Hospital; Department of Gynecologic Oncology
city: Adana
country: Turkey
facility: Adana Baskent University Hospital; Medical Oncology
city: Ankara
country: Turkey
facility: Ankara Baskent University Medicine Faculty; Gynaecology
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Kocaeli
country: Turkey
facility: Anadolu Health Center; Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.