Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
1 other identifier
interventional
682
5 countries
174
Brief Summary
Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2013
Longer than P75 for phase_3
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJuly 13, 2021
July 1, 2021
7.7 years
April 16, 2013
July 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
investigator-determined progression-free survival
every 12 weeks until progression or up to 30 months (whichever occurs first)
Secondary Outcomes (4)
biological progression-free survival by serum CA 125
every 3 weeks until progression or up to 30 months (whichever occurs first)
Health related Quality of Life (QoL)
Baseline and then every 12 weeks until investigator-determined progresssion-free survival and thereafter at every visit for th 5-years follow-up or death (whichever occurs first)
Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions
every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Overall Survival
every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months
Study Arms (2)
Control Arm
NO INTERVENTIONPatients receive bevacizumab 15 mg/kg iv on day 1 followed by gemcitabine 1000mg/m² iv on day 1 \& 8 and carboplatin AUC4 iv on day 1 every 3 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
Research Arm
EXPERIMENTALPatients receive bevacizumab 10 mg/kg iv on day 1 \& 15 followed by PLD 30mg/m² iv on day 1 carboplatin AUC4 iv on day 1 every 4 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube carcinoma or primary peritoneal carcinoma
- First disease recurrence \>6 months after first-line platinum-based chemotherapy
- Patients with measurable or non-measurable disease (RECIST v1.1) or CA 125 assessable disease (GCIG criteria) or histological proven diagnosis of relapse
- In case of cytoreductive surgery for recurrence, patients must be able to commence cytotoxic chemo-therapy within 8 weeks after cytoreductive surgery
- ECOG PS 0-2
- Absolute Neutrophil Count \>= 1.5 x 10\^9/L; Platelets \>= 100 x 10\^9/L; Hemoglobin \>= 9.5 g/dL
- Patients not receiving anticoagulant medication who have an International Normalized Ratio \<= 1.5 and an Activated ProThrombin Time \<= 1.5 x ULN
- Serum bilirubin \<= 2 x ULN; Serum transaminases \<= 2.5 x ULN (\<= 5 x ULN in the presence of liver metastasis)
- Serum creatinine \< 1.6 mg/dL or creatinine clearance \>= 40 mL/min; Glomerular filtration rate \> 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula); Urine dipstick for proteinuria \< 2+. If urine dipstick is \>= 2+, 24 hour urine collection must demonstrate \<= 1 g of protein in 24 hours
- Normal blood pressure or adequately treated and controlled hypertension (either systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg)
You may not qualify if:
- Ovarian tumors of low malignant potential
- Malignancies other than ovarian cancer within 5 years prior to randomization
- Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period
- Any previous radiotherapy to the abdomen or pelvis
- Known hypersensitivity to used chemotherapeutic agents in this trial and bevacizumab and its excipients, chinese hamster ovary cell products or other recombinant human or humanised antibodies
- Current or recent chronic use of aspirin \> 325 mg/day
- Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of Bevacizumab
- History of VEGF therapy related abdominal fistula or gastrointestinal perforation
- Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
- Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Previous Cerebro-Vascular Accident , Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Clinically significant disease, including: myocardial infarction or unstable angina within ≤ 6 months of randomization; New York Heart Association (NYHA) \>= grade 2 Congestive Heart Failure; poorly controlled cardiac arrhythmia despite medication; peripheral vascular disease grade \>= 3
- LVEF defined by ECHO/MUGA below the institutional lower limit of normal
- Significant traumatic injury during 4 weeks prior to randomization
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AGO Research GmbHlead
- Arbeitsgemeinschaft Gynaekologische Onkologie Austriacollaborator
- ARCAGY/ GINECO GROUPcollaborator
- Australia New Zealand Gynaecological Oncology Groupcollaborator
- Scottish Gynaecological Cancer Study Groupcollaborator
Study Sites (193)
Bankstown-Lidcombe Hospital
Bankstown, Australia
Chris O'Brien Lifehouse
Camperdown, Australia
NCCI - Coffs Harbour Hospital
Coffs Harbour, Australia
The Townsville Hospital
Douglas, Australia
Peninsula Health - Frankston Hospital
Frankston, Australia
Andrew Love Cancer Centre Geelong
Geelong, Australia
Royal Brisbane & Women's Hospital
Herston, Australia
Royal Hobart Hospital
Hobart, Australia
St. George Hospital
Kogarah, Australia
ICON Cancer Care Centre
Milton, Australia
Nambour General Hospital
Nambour, Australia
Sir Charles Gairdner
Nedlands, Australia
North Coast Cancer Institute
Port Macquarie, Australia
Royal Hospital for Women
Randwick, Australia
Mater Adult Hospital
South Brisbane, Australia
Gold Coast University Hospital
Southport, Australia
Royal North Shore Hospital
St Leonards, Australia
St. John of God Hospital
Subiaco, Australia
Border Medical Oncology
Wodonga, Australia
MUG-Universitätsklinik für Frauenheilkunde Graz
Graz, Austria
MUI-Universität für Frauenheilkunde
Innsbruck, Austria
AKH Linz
Linz, Austria
BHS Linz
Linz, Austria
SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe
Salzburg, Austria
MUW-AKH Wien
Vienna, Austria
UZ Leuven
Leuven, Belgium
ICO Paul Papin
Angers, France
Institut Sainte Catherine
Avignon, France
Centre Hospitalier de Blois
Blois, France
Clinique Tivoli
Bordeaux, France
Polyclinique Bordeaux Nord
Bordeaux, France
Centre Francois Baclesse
Caen, France
Centre Hospitalier William Morey
Chalon-sur-Saône, France
Centre Hospitalier de Cholet
Cholet, France
Hôpital Antoine Béclère
Clamart, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Hospitalier la Dracénie
Draguignan, France
Centre Hospitalier Général de Gap
Gap, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble
Grenoble, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France
Institut d'Oncologie Hartmann
Levallois-Perret, France
Centre Oscar Lambret
Lille, France
Hôpital Privé Clairval
Marseille, France
Institute Paoli Clamettes
Marseille, France
Hôpital Mercy
Metz, France
Hôpital de Mont-de-Marsan
Mont-de-Marsan, France
ICM Val d'Aurelle
Montpellier, France
Hôpital Emile Muller
Mulhouse, France
Centre d'Oncologie de Gentilly
Nancy, France
Centre Catherine de Sienne
Nantes, France
Centre Hospitalier Régional d'Orleans
Orléans, France
Group Hospitalier Saint-Joseph
Paris, France
Centre Catalan d'Oncologie
Perpignan, France
Clinique Francheville
Périgueux, France
Centre Eugène Marquis
Rennes, France
HôpitauxDrôme Nord - Site de Ramons
Romans-sur-Isère, France
Centre Henri Becquerel
Rouen, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
ICO Centre René Gauducheau
Saint-Herblain, France
Clinique Mutualiste de l'Estuaire, Cité Sanitaire
Saint-Nazaire, France
Centre Paul Strauss
Strasbourg, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Centre Hospitalier de Thonon-les-Bains
Thonon-les-Bains, France
Clinique Pasteur
Toulouse, France
Clinique Saint Jean du Languedoc
Toulouse, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie
Villeneuve-d'Ascq, France
Kreisklinik Altötting-Burghausen
Altötting, Germany
Klinikum St. Marien
Amberg, Germany
Klinikum Aschaffenburg
Aschaffenburg, Germany
Klinikum Augsburg
Augsburg, Germany
Hochtaunus-Klinik
Bad Homburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Praxisklinik Krebsheilkunde für Frauen
Berlin, Germany
Augusta-Kranken-Anstalt Bochum
Bochum, Germany
Johanniter-Krankenhaus
Bonn, Germany
Medizinisches Zentrum Bonn-Friedensplatz
Bonn, Germany
Schwerpunktpraxis für Onkologie / Hämatologie
Bottrop, Germany
Städtisches Klinikum Brandenburg
Brandenburg, Germany
Gynäkologisch-Onkologische Gemeinschaftspraxis
Braunschweig, Germany
DIAKO Ev. Diakonie-Krankenhaus
Bremen, Germany
Gynaekologicum Bremen
Bremen, Germany
Klinikum Bremen-Mitte
Bremen, Germany
Klinikum Chemnitz
Chemnitz, Germany
St. Elisabeth-Krankenhaus Hohenlind
Cologne, Germany
Universitätsklinikum Köln
Cologne, Germany
Klinikum Darmstadt
Darmstadt, Germany
Donau-Isar-Kliniken, Klinikum Deggendorf
Deggendorf, Germany
Städtisches Klinikum Dessau
Dessau, Germany
Klinikum Dortmund
Dortmund, Germany
Onkozentrum Dresden
Dresden, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany
Kaiserswerther Diakonie, Florence-Nightingale-Krankenhaus
Düsseldorf, Germany
Universitätsfrauenklinik Düsseldorf
Düsseldorf, Germany
Rottal-Inn-Klinik Eggenfelden
Eggenfelden, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Klinikum Essen Mitte
Essen, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
DIAKO Flensburg
Flensburg, Germany
Agaplesion Markus Krankenhaus
Frankfurt, Germany
Klinikum Frankfurt Höchst
Frankfurt, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Universitätsfrauenklinik Freiburg
Freiburg im Breisgau, Germany
Kreiskrankenhaus Freudenstadt
Freudenstadt, Germany
Klinikum Fürth
Fürth, Germany
Franziskus-Hospital Harderberg
Georgsmarienhütte, Germany
HELIOS-Klinikum Gifhorn
Gifhorn, Germany
Onkologische Kooperation Harz
Goslar, Germany
Die Frauenarztpraxis in Grafing
Grafing, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Universitätsklinikum Halle
Halle, Germany
Albertinen Krankenhaus
Hamburg, Germany
Marienkrankenhaus Hamburg
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Sana-Klinikum Hameln-Pyrmont
Hamelin, Germany
Klinikum Hanau
Hanau, Germany
Friederikenstift
Hanover, Germany
Gynäkologisch-Onkologische Praxis Hannover
Hanover, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Paracelsus-Klinik
Henstedt-Ulzburg, Germany
Praxis Dres. Uleer / Pourfard
Hildesheim, Germany
Klinikum Itzehoe
Itzehoe, Germany
Universitätsklinikum Jena
Jena, Germany
St. Vincentius Kliniken
Karlsruhe, Germany
Klinikum Kassel
Kassel, Germany
Klinikum Kempten
Kempten, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Zentrum für Gynäkologische Onkologie
Kiel, Germany
Klinikum Konstanz
Konstanz, Germany
Klinikum Kulmbach
Kulmbach, Germany
Asklepios Klinik Lich
Lich, Germany
St. Vincenz Krankenhaus
Limburg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Onkologische Schwerpunktpraxis Lüneburg
Lüneburg, Germany
Klinik St. Marienstift
Magdeburg, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Universitätsmedizin Mainz
Mainz, Germany
Universitätsfrauenklinik Mannheim
Mannheim, Germany
Universitätsklinikum Gießen und Marburg
Marburg, Germany
Johannes Wesling Klinikum
Minden, Germany
Klinikum rechts der Isar
München, Germany
LMU München, Frauenklinik Großhadern
München, Germany
Rotkreuzklinikum München
München, Germany
Universitätsklinikum Münster
Münster, Germany
Kliniken des Landkreises Neumarkt
Neumarkt, Germany
Lukaskrankenhaus
Neuss, Germany
MVZ Nordhausen
Nordhausen, Germany
Klinikum Nürnberg
Nuremberg, Germany
Klinikum Offenbach
Offenbach, Germany
Ortenau-Klinikum
Offenburg, Germany
Marienhospital
Osnabrück, Germany
St. Vincenz Krankenhaus
Paderborn, Germany
Onkologische Praxis Pinneberg
Pinneberg, Germany
Harzklinikum Quedlinburg
Quedlinburg, Germany
Onkologie Ravensburg
Ravensburg, Germany
imland Klinik Rendsburg
Rendsburg, Germany
Klinikum am Steinenberg
Reutlingen, Germany
Universitätsfrauenklinik Rostock
Rostock, Germany
Thüringen-Kliniken
Saalfeld, Germany
Caritasklinikum St. Theresia
Saarbrücken, Germany
Praxis Dr. med. W. Dietz
Salzgitter, Germany
Diakonie-Klinikum Schwäbisch Hall
Schwäbisch Hall, Germany
Leopoldina-Krankenhaus
Schweinfurt, Germany
HELIOS Kliniken Schwerin
Schwerin, Germany
Diakonie Klinikum Jung-Stilling
Siegen, Germany
Klinikum Schaumburg, Krankenhaus Stadthagen
Stadthagen, Germany
Klinikum Starnberg
Starnberg, Germany
g.Sund Gyn. Kompetenzzentrum
Stralsund, Germany
Marienhospital Stuttgart
Stuttgart, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
SRH Zentralklinikum Suhl
Suhl, Germany
Kreiskrankenhaus "J. Kentmann"
Torgau, Germany
Klinikum Traunstein
Traunstein, Germany
Klinikum Mutterhaus
Trier, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsfrauenklinik Ulm
Ulm, Germany
Praxis Dr. med. W. W. Reiter
Viersen, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Lahn-Dill-Kliniken Wetzlar
Wetzlar, Germany
Dr. Horst Schmidt Kliniken
Wiesbaden, Germany
St. Josefs Hospital Wiesbaden
Wiesbaden, Germany
amO am Klieversberg
Wolfsburg, Germany
Klinikum Worms
Worms, Germany
Heinrich-Braun-Klinikum
Zwickau, Germany
Gwynedd Hospital
Bangor, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
The Beatson West of Scotland Cancer Center
Glasgow, United Kingdom
Glan Clywd Hospital
Rhyl, United Kingdom
Related Publications (1)
Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, Sehouli J, Canzler U, Schmalfeldt B, Dean AP, Hein A, Zeimet AG, Hanker LC, Petit T, Marme F, El-Balat A, Glasspool R, de Gregorio N, Mahner S, Meniawy TM, Park-Simon TW, Mouret-Reynier MA, Costan C, Meier W, Reinthaller A, Goh JC, L'Haridon T, Baron Hay S, Kommoss S, du Bois A, Kurtz JE; AGO-OVAR 2.21/ENGOT-ov 18 Investigators. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 May;21(5):699-709. doi: 10.1016/S1470-2045(20)30142-X. Epub 2020 Apr 16.
PMID: 32305099RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jacobus Pfisterer, PhD MD
AGO Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2013
First Posted
April 23, 2013
Study Start
May 1, 2013
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
July 13, 2021
Record last verified: 2021-07