AzTrials
AzTrials

Recurrent Platinum-sensitive Ovarian CancerPhase 3NCT01837251

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

A Phase 3 study testing Carboplatin, PLD and Bevacizumab in people with Recurrent Platinum-sensitive Ovarian Cancer, run by AGO Research GmbH at 193 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin, PLD and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
682 participants
Where
193 sitesin 6 countries
Study dates
May 2013to Jan 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • Current brain metastases or spinal cord compression
  • History or evidence upon neurological examination of central nervous system disease
  • Non-healing wound, active ulcer or bone fracture
  • History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic coagulation)
  • 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
  • Pregnant or lactating women
  • Requirement of therapeutic anticoagulation using marcumar, warfarin or PTT-prolonging heparin

Trial locations and contacts

193 sites in 6 countries.

193 sites in 6 countries

Germany121 sites

  • Kreisklinik Altötting-Burghausen

    Altötting

  • Klinikum St. Marien

    Amberg

  • Klinikum Aschaffenburg

    Aschaffenburg

  • Klinikum Augsburg

    Augsburg

  • Hochtaunus-Klinik

    Bad Homburg

  • Charité - Universitätsmedizin Berlin

    Berlin

  • HELIOS Klinikum Berlin-Buch

    Berlin

  • Praxisklinik Krebsheilkunde für Frauen

    Berlin

  • Augusta-Kranken-Anstalt Bochum

    Bochum

  • Johanniter-Krankenhaus

    Bonn

  • Medizinisches Zentrum Bonn-Friedensplatz

    Bonn

  • Schwerpunktpraxis für Onkologie / Hämatologie

    Bottrop

  • Städtisches Klinikum Brandenburg

    Brandenburg

  • Gynäkologisch-Onkologische Gemeinschaftspraxis

    Braunschweig

  • DIAKO Ev. Diakonie-Krankenhaus

    Bremen

  • Gynaekologicum Bremen

    Bremen

  • Klinikum Bremen-Mitte

    Bremen

  • Klinikum Chemnitz

    Chemnitz

  • St. Elisabeth-Krankenhaus Hohenlind

    Cologne

  • Universitätsklinikum Köln

    Cologne

  • Klinikum Darmstadt

    Darmstadt

  • Donau-Isar-Kliniken, Klinikum Deggendorf

    Deggendorf

  • Städtisches Klinikum Dessau

    Dessau

  • Klinikum Dortmund

    Dortmund

  • Onkozentrum Dresden

    Dresden

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf

  • Kaiserswerther Diakonie, Florence-Nightingale-Krankenhaus

    Düsseldorf

  • Universitätsfrauenklinik Düsseldorf

    Düsseldorf

  • Rottal-Inn-Klinik Eggenfelden

    Eggenfelden

  • Universitätsklinikum Erlangen

    Erlangen

  • Klinikum Essen Mitte

    Essen

  • Universitätsklinikum Essen

    Essen

  • Klinikum Esslingen

    Esslingen am Neckar

  • DIAKO Flensburg

    Flensburg

  • Agaplesion Markus Krankenhaus

    Frankfurt

  • Klinikum Frankfurt Höchst

    Frankfurt

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Universitätsfrauenklinik Freiburg

    Freiburg im Breisgau

  • Kreiskrankenhaus Freudenstadt

    Freudenstadt

  • Klinikum Fürth

    Fürth

  • Franziskus-Hospital Harderberg

    Georgsmarienhütte

  • HELIOS-Klinikum Gifhorn

    Gifhorn

  • Onkologische Kooperation Harz

    Goslar

  • Die Frauenarztpraxis in Grafing

    Grafing

  • Universitätsmedizin Greifswald

    Greifswald

  • Universitätsklinikum Halle

    Halle

  • Albertinen Krankenhaus

    Hamburg

  • Marienkrankenhaus Hamburg

    Hamburg

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Sana-Klinikum Hameln-Pyrmont

    Hamelin

  • Klinikum Hanau

    Hanau

  • Friederikenstift

    Hanover

  • Gynäkologisch-Onkologische Praxis Hannover

    Hanover

  • Medizinische Hochschule Hannover

    Hanover

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Paracelsus-Klinik

    Henstedt-Ulzburg

  • Praxis Dres. Uleer / Pourfard

    Hildesheim

  • Klinikum Itzehoe

    Itzehoe

  • Universitätsklinikum Jena

    Jena

  • St. Vincentius Kliniken

    Karlsruhe

  • Klinikum Kassel

    Kassel

  • Klinikum Kempten

    Kempten

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Zentrum für Gynäkologische Onkologie

    Kiel

  • Klinikum Konstanz

    Konstanz

  • Klinikum Kulmbach

    Kulmbach

  • Asklepios Klinik Lich

    Lich

  • St. Vincenz Krankenhaus

    Limburg

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck

  • Onkologische Schwerpunktpraxis Lüneburg

    Lüneburg

  • Klinik St. Marienstift

    Magdeburg

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universitätsmedizin Mainz

    Mainz

  • Universitätsfrauenklinik Mannheim

    Mannheim

  • Universitätsklinikum Gießen und Marburg

    Marburg

  • Johannes Wesling Klinikum

    Minden

  • Klinikum rechts der Isar

    München

  • LMU München, Frauenklinik Großhadern

    München

  • Rotkreuzklinikum München

    München

  • Universitätsklinikum Münster

    Münster

  • Kliniken des Landkreises Neumarkt

    Neumarkt

  • Lukaskrankenhaus

    Neuss

  • MVZ Nordhausen

    Nordhausen

  • Klinikum Nürnberg

    Nuremberg

  • Klinikum Offenbach

    Offenbach

  • Ortenau-Klinikum

    Offenburg

  • Marienhospital

    Osnabrück

  • St. Vincenz Krankenhaus

    Paderborn

  • Onkologische Praxis Pinneberg

    Pinneberg

  • Harzklinikum Quedlinburg

    Quedlinburg

  • Onkologie Ravensburg

    Ravensburg

  • imland Klinik Rendsburg

    Rendsburg

  • Klinikum am Steinenberg

    Reutlingen

  • Universitätsfrauenklinik Rostock

    Rostock

  • Thüringen-Kliniken

    Saalfeld

  • Caritasklinikum St. Theresia

    Saarbrücken

  • Praxis Dr. med. W. Dietz

    Salzgitter

  • Diakonie-Klinikum Schwäbisch Hall

    Schwäbisch Hall

  • Leopoldina-Krankenhaus

    Schweinfurt

  • HELIOS Kliniken Schwerin

    Schwerin

  • Diakonie Klinikum Jung-Stilling

    Siegen

  • Klinikum Schaumburg, Krankenhaus Stadthagen

    Stadthagen

  • Klinikum Starnberg

    Starnberg

  • g.Sund Gyn. Kompetenzzentrum

    Stralsund

  • Marienhospital Stuttgart

    Stuttgart

  • Robert-Bosch-Krankenhaus

    Stuttgart

  • SRH Zentralklinikum Suhl

    Suhl

  • Kreiskrankenhaus "J. Kentmann"

    Torgau

  • Klinikum Traunstein

    Traunstein

  • Klinikum Mutterhaus

    Trier

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsfrauenklinik Ulm

    Ulm

  • Praxis Dr. med. W. W. Reiter

    Viersen

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen

    Villingen-Schwenningen

  • Lahn-Dill-Kliniken Wetzlar

    Wetzlar

  • Dr. Horst Schmidt Kliniken

    Wiesbaden

  • St. Josefs Hospital Wiesbaden

    Wiesbaden

  • amO am Klieversberg

    Wolfsburg

  • Klinikum Worms

    Worms

  • Heinrich-Braun-Klinikum

    Zwickau

Other trials in Germany

France42 sites

  • ICO Paul Papin

    Angers

  • Institut Sainte Catherine

    Avignon

  • Centre Hospitalier de Blois

    Blois

  • Clinique Tivoli

    Bordeaux

  • Polyclinique Bordeaux Nord

    Bordeaux

  • Centre Francois Baclesse

    Caen

  • Centre Hospitalier William Morey

    Chalon-sur-Saône

  • Centre Hospitalier de Cholet

    Cholet

  • Hôpital Antoine Béclère

    Clamart

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Hospitalier la Dracénie

    Draguignan

  • Centre Hospitalier Général de Gap

    Gap

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble

  • Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble

    Grenoble

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon

  • Institut d'Oncologie Hartmann

    Levallois-Perret

  • Centre Oscar Lambret

    Lille

  • Hôpital Privé Clairval

    Marseille

  • Institute Paoli Clamettes

    Marseille

  • Hôpital Mercy

    Metz

  • Hôpital de Mont-de-Marsan

    Mont-de-Marsan

  • ICM Val d'Aurelle

    Montpellier

  • Hôpital Emile Muller

    Mulhouse

  • Centre d'Oncologie de Gentilly

    Nancy

  • Centre Catherine de Sienne

    Nantes

  • Centre Hospitalier Régional d'Orleans

    Orléans

  • Group Hospitalier Saint-Joseph

    Paris

  • Clinique Francheville

    Périgueux

  • Centre Catalan d'Oncologie

    Perpignan

  • Centre Eugène Marquis

    Rennes

  • HôpitauxDrôme Nord - Site de Ramons

    Romans-sur-Isère

  • Centre Henri Becquerel

    Rouen

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc

  • ICO Centre René Gauducheau

    Saint-Herblain

  • Clinique Mutualiste de l'Estuaire, Cité Sanitaire

    Saint-Nazaire

  • Centre Paul Strauss

    Strasbourg

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • Centre Hospitalier de Thonon-les-Bains

    Thonon-les-Bains

  • Clinique Pasteur

    Toulouse

  • Clinique Saint Jean du Languedoc

    Toulouse

  • Centre Hospitalier Bretagne Atlantique

    Vannes

  • Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie

    Villeneuve-d'Ascq

Other trials in France

Australia19 sites

  • Bankstown-Lidcombe Hospital

    Bankstown

  • Chris O'Brien Lifehouse

    Camperdown

  • NCCI - Coffs Harbour Hospital

    Coffs Harbour

  • The Townsville Hospital

    Douglas

  • Peninsula Health - Frankston Hospital

    Frankston

  • Andrew Love Cancer Centre Geelong

    Geelong

  • Royal Brisbane & Women's Hospital

    Herston

  • Royal Hobart Hospital

    Hobart

  • St. George Hospital

    Kogarah

  • ICON Cancer Care Centre

    Milton

  • Nambour General Hospital

    Nambour

  • Sir Charles Gairdner

    Nedlands

  • North Coast Cancer Institute

    Port Macquarie

  • Royal Hospital for Women

    Randwick

  • Mater Adult Hospital

    South Brisbane

  • Gold Coast University Hospital

    Southport

  • Royal North Shore Hospital

    St Leonards

  • St. John of God Hospital

    Subiaco

  • Border Medical Oncology

    Wodonga

Other trials in Australia

Austria6 sites

  • MUG-Universitätsklinik für Frauenheilkunde Graz

    Graz

  • MUI-Universität für Frauenheilkunde

    Innsbruck

  • AKH Linz

    Linz

  • BHS Linz

    Linz

  • SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe

    Salzburg

  • MUW-AKH Wien

    Vienna

Other trials in Austria

United Kingdom4 sites

  • Gwynedd Hospital

    Bangor

  • Velindre Cancer Centre

    Cardiff

  • The Beatson West of Scotland Cancer Center

    Glasgow

  • Glan Clywd Hospital

    Rhyl

Other trials in United Kingdom

Belgium1 site

  • UZ Leuven

    Leuven

Other trials in Belgium

About this study

Official title: 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.

Being tested
Carboplatin, PLD, Bevacizumab
Keywords
Ovarian Carcinoma, Bevacizumab, Gemcitabine, PLD, pegylated liposomal doxorubicin, Carboplatin, best therapeutic index, progression-free survival
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01837251
Study groupRoleWhat they receive
Control ArmNo 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 ArmExperimentalPatients 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.
Receives: Drug: Carboplatin; Drug: PLD; Biological: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. investigator-determined progression-free survival

    Measured: every 12 weeks until progression or up to 30 months (whichever occurs first)

Secondary outcomes (4)

  1. biological progression-free survival by serum CA 125

    Measured: every 3 weeks until progression or up to 30 months (whichever occurs first)

  2. Health related Quality of Life (QoL)

    Measured: 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)

  3. Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions

    Measured: every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)

  4. Overall Survival

    Measured: every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJan 2021
  4. Study completionJan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01837251
Sponsor's protocol ID
AGO-OVAR 2.21 / ENGOT ov-18
Status last verified
Jul 2021
First submitted
16 Apr 2013
Last updated
13 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32305099

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, PLD and Bevacizumab in people with Recurrent Platinum-sensitive Ovarian Cancer, run by AGO Research GmbH at 193 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in Germany, France, Australia, Austria, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

investigator-determined progression-free survival (time frame: every 12 weeks until progression or up to 30 months (whichever occurs first)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01837251, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.

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