AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer
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
Sites / Locations
- Institut Jules Bordet
- UZ Antwerpen
- UZ Leuven Gasthuisberg
- Clinique Ste-Elisabeth
- University Clinical Centre of the Republic of Srpska
- Clinic of Oncology, University Clinical Center Sarajevo
- University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition
- Herlev Hospital; Afdeling for Kræftbehandling
- Regionshospitalet Herning; Onkologisk afdeling
- Rigshospitalet; Onkologisk Klinik
- Odense Universitetshospital, Onkologisk Afdeling R
- Kuopio University Hospital
- Oulu University Hospital; Gynaecology & Obstetrics Dept
- Clinique Sainte Catherine; Hopital De Semaine
- Clinique Tivoli; Sce Radiotherapie
- Institut Bergonie; Gynecologie
- Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
- Ch De Brive La Gaillarde; Radiotherapie Oncologie
- Centre Francois Baclesse; Urologie Gynecologie
- Centre Jean Perrin; Hopital De Jour
- Hopital Louis Pasteur; Medecine B
- Institut Daniel Hollard; Chimiotherapie Ambulatoire
- Centre Hospitalier Departemental Les Oudairies
- Hopital La Source; Onco Med Hematologie Clinique
- Hopital Andre Mignot; Hematologie - Oncologie
- Centre Jean Bernard
- Centre Oscar Lambret; Cancerologie Gynecologique
- Clin Mut De Lyon Eugene Andre; Medecine 3 A
- Hopital Layne; Medecine Ambulatoire
- Centre Val Aurelle Paul Lamarque; Medecine A1 A2
- Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
- Centre Catherine de Sienne; Chimiotherapie
- Centre Antoine Lacassagne; Hopital De Jour A2
- Polyclinique Kenval ; Radiotherapie Oncologie
- Hotel Dieu; Hematologie- Oncologie
- Institut Curie; Oncologie Medicale
- Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
- HOPITAL TENON; Cancerologie Medicale
- Clinique Francheville; Radiotherapie
- Institut Jean Godinot; Oncologie Medicale
- Centre Henri Becquerel; Oncologie Medicale
- Clinique Armoricaine Radiologie; Cons Externes
- Ico Rene Gauducheau; Oncologie
- Centre Radiotherapie Etienne Dolet
- Centre Rene Huguenin; Medecine B
- Hopital Civil; Expl Fonct Systeme Nerveux
- Hopitaux Du Leman Site Thonon; Maternite Gynecologie
- Institut Claudius Regaud; Departement Oncologie Medicale
- Centre Alexis Vautrin; Oncologie Medicale
- HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
- Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
- Evangelischen Krankenhauses Düsseldorf; Frauenklinik
- Uni-Frauenklinik
- Universitätsklinikum Erlangen; Frauenklinik
- Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
- Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
- Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
- Kath.Marienkrankenhaus gGmbH Frauenklinik
- Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
- Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
- Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
- UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
- HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
- Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
- Universitätsklinikum Mannheim; Frauenklinik
- Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
- Klinikum Nord Frauenklinik
- Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
- Oncologianova GmbH
- Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
- Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe
- Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum
- Universitätsklinik Tübingen; Frauenklinik & Poliklinik
- Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
- Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe
- University Hospital of Alexandra
- Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
- A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
- AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia
- Istituto Regina Elena; Oncologia Medica A
- Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia
- Ospedali Riuniti; Divisione Ostetricia e Ginecologia
- Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
- Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
- Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
- Leyenburg Ziekenhuis; Internal Medecine
- Catharina ZKHS; Inwendige Geneeskunde Afd.
- Martini Ziekenhuis; Dept of Internal Medicine
- Stichting St. Antonius Ziekenhuis
- Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
- The Norvegian Radium Hospital Montebello; Dept of Oncology
- St. Olavs Hospital; Kvinneklinikken
- IPO de Lisboa; Servico de Oncologia Medica
- IPO do Porto; Servico de Oncologia Medica
- Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
- Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
- Hospital Universitario Reina Sofia; Servicio de Oncologia
- Hospital Son Llatzer; Servicio de Oncologia
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
- Hospital de Terrassa; Servicio de Oncologia
- Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
- Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
- Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
- Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
- Instituto Valenciano Oncologia; Oncologia Medica
- Hospital Universitario la Fe; Servicio de Oncologia
- Hospital Universitario Miguel Servet; Servicio Oncologia
- Uni Hospital Linkoeping; Dept. of Oncology
- Norrlands Uni Hospital; Onkologi Avd.
- Akademiska sjukhuset, Onkologkliniken
- Örebro University Hospital; Department of Gynecologic Oncology
- Adana Baskent University Hospital; Medical Oncology
- Ankara Baskent University Medicine Faculty; Gynaecology
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
- Anadolu Health Center; Medical Oncology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Chemotherapy
Chemotherapy + Bevacizumab
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.
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.