Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

July 8, 2021 updated by: AGO Research GmbH

A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bankstown, Australia
        • Bankstown-Lidcombe Hospital
      • Camperdown, Australia
        • Chris O'Brien Lifehouse
      • Coffs Harbour, Australia
        • NCCI - Coffs Harbour Hospital
      • Douglas, Australia
        • The Townsville Hospital
      • Frankston, Australia
        • Peninsula Health - Frankston Hospital
      • Geelong, Australia
        • Andrew Love Cancer Centre Geelong
      • Herston, Australia
        • Royal Brisbane & Women's Hospital
      • Hobart, Australia
        • Royal Hobart Hospital
      • Kogarah, Australia
        • St. George Hospital
      • Milton, Australia
        • Icon Cancer Care Centre
      • Nambour, Australia
        • Nambour General Hospital
      • Nedlands, Australia
        • Sir Charles Gairdner
      • Port Macquarie, Australia
        • North Coast Cancer Institute
      • Randwick, Australia
        • Royal Hospital for Women
      • South Brisbane, Australia
        • Mater Adult Hospital
      • Southport, Australia
        • Gold Coast University Hospital
      • St. Leonards, Australia
        • Royal North Shore Hospital
      • Subiaco, Australia
        • St. John of God Hospital
      • Wodonga, Australia
        • Border Medical Oncology
  • Austria
      • Graz, Austria
        • MUG-Universitätsklinik für Frauenheilkunde Graz
      • Innsbruck, Austria
        • MUI-Universität für Frauenheilkunde
      • Linz, Austria
        • AKH Linz
      • Linz, Austria
        • BHS Linz
      • Salzburg, Austria
        • SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe
      • Wien, Austria
        • MUW-AKH Wien
  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • France
      • Angers, France
        • ICO Paul Papin
      • Avignon, France
        • Institut Sainte Catherine
      • Blois, France
        • Centre Hospitalier de Blois
      • Bordeaux, France
        • Clinique Tivoli
      • Bordeaux, France
        • Polyclinique Bordeaux Nord
      • Caen, France
        • Centre Francois Baclesse
      • Chalon-Sur-Saone, France
        • Centre Hospitalier William Morey
      • Cholet, France
        • Centre Hospitalier de Cholet
      • Clamart, France
        • Hôpital Antoine Béclère
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Draguignan, France
        • Centre Hospitalier la Dracénie
      • Gap, France
        • Centre Hospitalier Général de Gap
      • Grenoble, France
        • Groupe Hospitalier Mutualiste de Grenoble
      • Grenoble, France
        • Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble
      • La Roche sur Yon, France
        • Centre Hospitalier Départemental Les Oudairies
      • Levallois-Perret, France
        • Institut d'Oncologie Hartmann
      • Lille, France
        • Centre OSCAR LAMBRET
      • Marseille, France
        • Hôpital privé Clairval
      • Marseille, France
        • Institute Paoli Clamettes
      • Metz, France
        • Hopital Mercy
      • Mont de Marsan, France
        • Hôpital de Mont-de-Marsan
      • Montpellier, France
        • ICM Val D'Aurelle
      • Mulhouse, France
        • Hôpital Emile Muller
      • Nancy, France
        • Centre d'oncologie de Gentilly
      • Nantes, France
        • Centre Catherine de Sienne
      • Orleans, France
        • Centre Hospitalier Regional D'Orleans
      • Paris, France
        • Group Hospitalier Saint-Joseph
      • Perpignan, France
        • Centre Catalan d'Oncologie
      • Périgueux, France
        • Clinique Francheville
      • Rennes, France
        • Centre Eugene Marquis
      • Romans-sur-Isère, France
        • HôpitauxDrôme Nord - Site de Ramons
      • Rouen, France
        • Centre Henri Becquerel
      • Saint Brieuc, France
        • Clinique Armoricaine de Radiologie
      • Saint Herblain, France
        • ICO Centre Rene Gauducheau
      • Saint Nazaire, France
        • Clinique Mutualiste de l'Estuaire, Cité Sanitaire
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France
        • Centre Paul Strauss
      • Thonon-les-Bains, France
        • Centre Hospitalier de Thonon-les-Bains
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • Clinique Saint Jean du Languedoc
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique
      • Villeneuve d'Ascq, France
        • Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie
  • Germany
      • Altötting, Germany
        • Kreisklinik Altötting-Burghausen
      • Amberg, Germany
        • Klinikum St. Marien
      • Aschaffenburg, Germany
        • Klinikum Aschaffenburg
      • Augsburg, Germany
        • Klinikum Augsburg
      • Bad Homburg, Germany
        • Hochtaunus-Klinik
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany
        • Praxisklinik Krebsheilkunde fur Frauen
      • Bochum, Germany
        • Augusta-Kranken-Anstalt Bochum
      • Bonn, Germany
        • Johanniter-Krankenhaus
      • Bonn, Germany
        • Medizinisches Zentrum Bonn-Friedensplatz
      • Bottrop, Germany
        • Schwerpunktpraxis für Onkologie / Hämatologie
      • Brandenburg, Germany
        • Städtisches Klinikum Brandenburg
      • Braunschweig, Germany
        • Gynäkologisch-Onkologische Gemeinschaftspraxis
      • Bremen, Germany
        • Klinikum Bremen-Mitte
      • Bremen, Germany
        • DIAKO Ev. Diakonie-Krankenhaus
      • Bremen, Germany
        • GYNAEKOLOGICUM Bremen
      • Chemnitz, Germany
        • Klinikum Chemnitz
      • Darmstadt, Germany
        • Klinikum Darmstadt
      • Deggendorf, Germany
        • Donau-Isar-Kliniken, Klinikum Deggendorf
      • Dessau, Germany
        • Städtisches Klinikum Dessau
      • Dortmund, Germany
        • Klinikum Dortmund
      • Dresden, Germany
        • Universitätsklinikum Carl Gustav Carus
      • Dresden, Germany
        • Onkozentrum Dresden
      • Düsseldorf, Germany
        • Evangelisches Krankenhaus Düsseldorf
      • Düsseldorf, Germany
        • Kaiserswerther Diakonie, Florence-Nightingale-Krankenhaus
      • Düsseldorf, Germany
        • Universitätsfrauenklinik Düsseldorf
      • Eggenfelden, Germany
        • Rottal-Inn-Klinik Eggenfelden
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Universitätsklinikum Essen
      • Essen, Germany
        • Klinikum Essen Mitte
      • Esslingen, Germany
        • Klinikum Esslingen
      • Flensburg, Germany
        • DIAKO Flensburg
      • Frankfurt, Germany
        • Agaplesion Markus Krankenhaus
      • Frankfurt, Germany
        • Klinikum Frankfurt Höchst
      • Frankfurt, Germany
        • Universitatsklinikum Frankfurt
      • Freiburg, Germany
        • Universitätsfrauenklinik Freiburg
      • Freudenstadt, Germany
        • Kreiskrankenhaus Freudenstadt
      • Fürth, Germany
        • Klinikum Fürth
      • Georgsmarienhütte, Germany
        • Franziskus-Hospital Harderberg
      • Gifhorn, Germany
        • HELIOS-Klinikum Gifhorn
      • Goslar, Germany
        • Onkologische Kooperation Harz
      • Grafing, Germany
        • Die Frauenarztpraxis in Grafing
      • Greifswald, Germany
        • Universitätsmedizin Greifswald
      • Halle, Germany
        • Universitätsklinikum Halle
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany
        • Albertinen Krankenhaus
      • Hamburg, Germany
        • Marienkrankenhaus Hamburg
      • Hameln, Germany
        • Sana-Klinikum Hameln-Pyrmont
      • Hanau, Germany
        • Klinikum Hanau
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Hannover, Germany
        • Friederikenstift
      • Hannover, Germany
        • Gynakologisch-Onkologische Praxis Hannover
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg
      • Henstedt-Ulzburg, Germany
        • Paracelsus-Klinik
      • Hildesheim, Germany
        • Praxis Dres. Uleer / Pourfard
      • Itzehoe, Germany
        • Klinikum Itzehoe
      • Jena, Germany
        • Universitätsklinikum Jena
      • Karlsruhe, Germany
        • St. Vincentius Kliniken
      • Kassel, Germany
        • Klinikum Kassel
      • Kempten, Germany
        • Klinikum Kempten
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Kiel, Germany
        • Zentrum für Gynäkologische Onkologie
      • Konstanz, Germany
        • Klinikum Konstanz
      • Kulmbach, Germany
        • Klinikum Kulmbach
      • Köln, Germany
        • Universitätsklinikum Köln
      • Köln, Germany
        • St. Elisabeth-Krankenhaus Hohenlind
      • Lich, Germany
        • Asklepios Klinik Lich
      • Limburg, Germany
        • St. Vincenz Krankenhaus
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Lüneburg, Germany
        • Onkologische Schwerpunktpraxis Lüneburg
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg
      • Magdeburg, Germany
        • Klinik St. Marienstift
      • Mainz, Germany
        • Universitätsmedizin Mainz
      • Mannheim, Germany
        • Universitätsfrauenklinik Mannheim
      • Marburg, Germany
        • Universitätsklinikum Giessen und Marburg
      • Minden, Germany
        • Johannes Wesling Klinikum
      • München, Germany
        • Klinikum rechts der Isar
      • München, Germany
        • Rotkreuzklinikum Munchen
      • München, Germany
        • LMU München, Frauenklinik Großhadern
      • Münster, Germany
        • Universitatsklinikum Munster
      • Neumarkt, Germany
        • Kliniken des Landkreises Neumarkt
      • Neuss, Germany
        • Lukaskrankenhaus
      • Nordhausen, Germany
        • MVZ Nordhausen
      • Nürnberg, Germany
        • Klinikum Nürnberg
      • Offenbach, Germany
        • Klinikum Offenbach
      • Offenburg, Germany
        • Ortenau-Klinikum
      • Osnabrück, Germany
        • Marienhospital
      • Paderborn, Germany
        • St. Vincenz Krankenhaus
      • Pinneberg, Germany
        • Onkologische Praxis Pinneberg
      • Quedlinburg, Germany
        • Harzklinikum Quedlinburg
      • Ravensburg, Germany
        • Onkologie Ravensburg
      • Rendsburg, Germany
        • Imland Klinik Rendsburg
      • Reutlingen, Germany
        • Klinikum am Steinenberg
      • Rostock, Germany
        • Universitätsfrauenklinik Rostock
      • Saalfeld, Germany
        • Thüringen-Kliniken
      • Saarbrücken, Germany
        • CaritasKlinikum St. Theresia
      • Salzgitter, Germany
        • Praxis Dr. med. W. Dietz
      • Schweinfurt, Germany
        • Leopoldina-Krankenhaus
      • Schwerin, Germany
        • HELIOS Kliniken Schwerin
      • Schwäbisch Hall, Germany
        • Diakonie-Klinikum Schwäbisch Hall
      • Siegen, Germany
        • Diakonie Klinikum Jung-Stilling
      • Stadthagen, Germany
        • Klinikum Schaumburg, Krankenhaus Stadthagen
      • Starnberg, Germany
        • Klinikum Starnberg
      • Stralsund, Germany
        • g.Sund Gyn. Kompetenzzentrum
      • Stuttgart, Germany
        • Robert-Bosch-Krankenhaus
      • Stuttgart, Germany
        • Marienhospital Stuttgart
      • Suhl, Germany
        • SRH Zentralklinikum Suhl
      • Torgau, Germany
        • Kreiskrankenhaus "J. Kentmann"
      • Traunstein, Germany
        • Klinikum Traunstein
      • Trier, Germany
        • Klinikum Mutterhaus
      • Tübingen, Germany
        • Universitätsklinikum Tübingen
      • Ulm, Germany
        • Universitätsfrauenklinik Ulm
      • Viersen, Germany
        • Praxis Dr. med. W. W. Reiter
      • Villingen-Schwenningen, Germany
        • Schwarzwald-Baar Klinikum Villingen-Schwenningen
      • Wetzlar, Germany
        • Lahn-Dill-Kliniken Wetzlar
      • Wiesbaden, Germany
        • Dr. Horst Schmidt Kliniken
      • Wiesbaden, Germany
        • St. Josefs Hospital Wiesbaden
      • Wolfsburg, Germany
        • amO am Klieversberg
      • Worms, Germany
        • Klinikum Worms
      • Zwickau, Germany
        • Heinrich-Braun-Klinikum
  • United Kingdom
      • Bangor, United Kingdom
        • Gwynedd Hospital
      • Cardiff, United Kingdom
        • Velindre Cancer Centre
      • Glasgow, United Kingdom
        • The Beatson West of Scotland Cancer Center
      • Rhyl, United Kingdom
        • Glan Clywd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube carcinoma or primary peritoneal carcinoma
  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:

  1. Ovarian tumors of low malignant potential
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Drug: Carboplatin
Biological: Bevacizumab
Drug: PLD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
investigator-determined progression-free survival
Time Frame: every 12 weeks until progression or up to 30 months (whichever occurs first)
every 12 weeks until progression or up to 30 months (whichever occurs first)

Secondary Outcome Measures

Outcome Measure
Time Frame
biological progression-free survival by serum CA 125
Time Frame: every 3 weeks until progression or up to 30 months (whichever occurs first)
every 3 weeks until progression or up to 30 months (whichever occurs first)
Health related Quality of Life (QoL)
Time Frame: 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)
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
Time Frame: every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Overall Survival
Time Frame: every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months
every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGO Research GmbH

Collaborators

ARCAGY/ GINECO GROUP
Australia New Zealand Gynaecological Oncology Group
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
Scottish Gynaecological Cancer Study Group

Investigators

  • Study Chair: Jacobus Pfisterer, PhD MD, AGO Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO-OVAR 2.21 / ENGOT ov-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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