Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
NCT ID: NCT01837251
Last Updated: 2021-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
682 participants
INTERVENTIONAL
2013-05-31
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Arm
Patients 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.
No interventions assigned to this group
Research Arm
Patients 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.
Carboplatin
PLD
Bevacizumab
Interventions
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Carboplatin
PLD
Bevacizumab
Eligibility Criteria
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Inclusion Criteria
2. First disease recurrence \>6 months after first-line platinum-based chemotherapy
3. Patients with measurable or non-measurable disease (RECIST v1.1) or CA 125 assessable disease (GCIG criteria) or histological proven diagnosis of relapse
4. In case of cytoreductive surgery for recurrence, patients must be able to commence cytotoxic chemo-therapy within 8 weeks after cytoreductive surgery
5. ECOG PS 0-2
6. Absolute Neutrophil Count \>= 1.5 x 10\^9/L; Platelets \>= 100 x 10\^9/L; Hemoglobin \>= 9.5 g/dL
7. Patients not receiving anticoagulant medication who have an International Normalized Ratio \<= 1.5 and an Activated ProThrombin Time \<= 1.5 x ULN
8. Serum bilirubin \<= 2 x ULN; Serum transaminases \<= 2.5 x ULN (\<= 5 x ULN in the presence of liver metastasis)
9. 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
10. Normal blood pressure or adequately treated and controlled hypertension (either systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg)
Exclusion Criteria
2. Malignancies other than ovarian cancer within 5 years prior to randomization
3. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period
4. Any previous radiotherapy to the abdomen or pelvis
5. 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
6. Current or recent chronic use of aspirin \> 325 mg/day
7. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of Bevacizumab
8. History of VEGF therapy related abdominal fistula or gastrointestinal perforation
9. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
10. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
11. Previous Cerebro-Vascular Accident , Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage
12. Prior history of hypertensive crisis or hypertensive encephalopathy
13. 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
14. LVEF defined by ECHO/MUGA below the institutional lower limit of normal
15. Significant traumatic injury during 4 weeks prior to randomization
16. Current brain metastases or spinal cord compression
17. History or evidence upon neurological examination of central nervous system disease
18. Non-healing wound, active ulcer or bone fracture
19. History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
20. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic coagulation)
21. Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the duration of the trial and at least 6 months afterwards
22. Pregnant or lactating women
23. Requirement of therapeutic anticoagulation using marcumar, warfarin or PTT-prolonging heparin
18 Years
FEMALE
No
Sponsors
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Arbeitsgemeinschaft Gynaekologische Onkologie Austria
OTHER
ARCAGY/ GINECO GROUP
OTHER
Australia New Zealand Gynaecological Oncology Group
OTHER
Scottish Gynaecological Cancer Study Group
OTHER
AGO Research GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Jacobus Pfisterer, PhD MD
Role: STUDY_CHAIR
AGO Study Group
Locations
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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
Countries
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References
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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.
Related Links
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Homepage of AGO Study Group
Other Identifiers
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AGO-OVAR 2.21 / ENGOT ov-18
Identifier Type: -
Identifier Source: org_study_id
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