Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Conditions
Recurrent Platinum-sensitive Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Ovarian Carcinoma, Bevacizumab, Gemcitabine, PLD, pegylated liposomal doxorubicin, Carboplatin, best therapeutic index, progression-free survival
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carboplatin Type: Drug
Name: PLD Type: Drug
Name: Bevacizumab Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Locations
Bankstown-Lidcombe Hospital
Bankstown, Australia
Status: Recruiting
Chris O'Brien Lifehouse
Camperdown, Australia
Status: Recruiting
NCCI - Coffs Harbour Hospital
Coffs Harbour, Australia
Status: Recruiting
The Townsville Hospital
Douglas, Australia
Status: Recruiting
Peninsula Health - Frankston Hospital
Frankston VIC, Australia
Status: Recruiting
Andrew Love Cancer Centre Geelong
Geelong, Australia
Status: Recruiting
Royal Brisbane & Women's Hospital
Herston, Australia
Status: Recruiting
Royal Hobart Hospital
Hobart, Australia
Status: Recruiting
St. George Hospital
Kogarah, Australia
Status: Recruiting
ICON Cancer Care Centre
Milton, Australia
Status: Recruiting
Nambour General Hospital
Nambour, Australia
Status: Recruiting
Sir Charles Gairdner
Nedlands, Australia
Status: Recruiting
North Coast Cancer Institute
Port Macquarie, Australia
Status: Recruiting
Royal Hospital for Women
Randwick, Australia
Status: Recruiting
Mater Adult Hospital
South Brisbane, Australia
Status: Recruiting
Gold Coast University Hospital
Southport, Australia
Status: Recruiting
Royal North Shore Hospital
St. Leonards, Australia
Status: Recruiting
St. John of God Hospital
Subiaco, Australia
Status: Recruiting
St. John of God Bunbury Hospital
Western Australia, Australia
Status: Recruiting
Border Medical Oncology
Wodonga, Australia
Status: Recruiting
MUG-Universitätsklinik für Frauenheilkunde Graz
Graz, Austria
Status: Recruiting
MUI-Universität für Frauenheilkunde
Innsbruck, Austria
Status: Recruiting
AKH Linz
Linz, Austria
Status: Recruiting
BHS Linz
Linz, Austria
Status: Recruiting
SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe
Salzburg, Austria
Status: Recruiting
MUW-AKH Wien
Wien, Austria
Status: Recruiting
ICO Paul Papin
Angers, France
Status: Recruiting
Institut Sainte Catherine
Avignon, France
Status: Recruiting
Centre Hospitalier de Blois
Blois, France
Status: Recruiting
Clinique Tivoli
Bordeaux, France
Status: Recruiting
Polyclinique Bordeaux Nord
Bordeaux, France
Status: Recruiting
Centre Francois Baclesse
Caen, France
Status: Recruiting
Centre Hospitalier William Morey
Chalon-Sur-Saone, France
Status: Recruiting
Centre Hospitalier de Cholet
Cholet, France
Status: Recruiting
Hôpital Antoine Béclère
Clamart, France
Status: Recruiting
Centre Jean Perrin
Clermont-Ferrand, France
Status: Recruiting
Centre Hospitalier la Dracénie
Draguignan, France
Status: Recruiting
Centre Hospitalier Général de Gap
Gap, France
Status: Recruiting
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Status: Recruiting
Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble
Grenoble, France
Status: Recruiting
Centre Hospitalier Départemental Les Oudairies
La Roche sur Yon, France
Status: Recruiting
Institut d'Oncologie Hartmann
Levallois-Perret, France
Status: Recruiting
Centre Oscar Lambret
Lille, France
Status: Recruiting
Hôpital Privé Clairval
Marseille, France
Status: Recruiting
Institute Paoli Clamettes
Marseille, France
Status: Recruiting
Hôpital Mercy
Metz, France
Status: Recruiting
Hôpital de Mont-de-Marsan
Mont de Marsan, France
Status: Recruiting
ICM Val d'Aurelle
Montpellier, France
Status: Recruiting
Hôpital Emile Muller
Mulhouse, France
Status: Recruiting
Centre d'Oncologie de Gentilly
Nancy, France
Status: Recruiting
Centre Catherine de Sienne
Nantes, France
Status: Recruiting
Centre Hospitalier Régional d'Orleans
Orleans, France
Status: Recruiting
Group Hospitalier Saint-Joseph
Paris, France
Status: Recruiting
Clinique Francheville
Perigeux, France
Status: Recruiting
Centre Catalan d'Oncologie
Perpignan, France
Status: Recruiting
Centre Eugène Marquis
Rennes, France
Status: Recruiting
HôpitauxDrôme Nord - Site de Ramons
Romans-sur-Isère, France
Status: Recruiting
Centre Henri Becquerel
Rouen, France
Status: Recruiting
Clinique Armoricaine de Radiologie
Saint Brieuc, France
Status: Recruiting
ICO Centre René Gauducheau
Saint Herblain, France
Status: Recruiting
Clinique Mutualiste de l'Estuaire, Cité Sanitaire
Saint Nazaire, France
Status: Recruiting
Centre Paul Strauss
Strasbourg, France
Status: Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Status: Recruiting
Centre Hospitalier de Thonon-les-Bains
Thonon-les-Bains, France
Status: Recruiting
Clinique Pasteur
Toulouse, France
Status: Recruiting
Clinique Saint Jean du Languedoc
Toulouse, France
Status: Recruiting
Centre Hospitalier Bretagne Atlantique
Vannes, France
Status: Recruiting
Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie
Villeneuve d'Ascq, France
Status: Recruiting
Kreisklinik Altötting-Burghausen
Altötting, Germany
Status: Recruiting
Klinikum St. Marien
Amberg, Germany
Status: Recruiting
Klinikum Aschaffenburg
Aschaffenburg, Germany
Status: Recruiting
Klinikum Augsburg
Augsburg, Germany
Status: Recruiting
Hochtaunus-Klinik
Bad Homburg, Germany
Status: Recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany
Status: Recruiting
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Status: Recruiting
Praxisklinik Krebsheilkunde für Frauen
Berlin, Germany
Status: Recruiting
Augusta-Kranken-Anstalt Bochum
Bochum, Germany
Status: Recruiting
Johanniter-Krankenhaus
Bonn, Germany
Status: Recruiting
Medizinisches Zentrum Bonn-Friedensplatz
Bonn, Germany
Status: Recruiting
Schwerpunktpraxis für Onkologie / Hämatologie
Bottrop, Germany
Status: Recruiting
Städtisches Klinikum Brandenburg
Brandenburg, Germany
Status: Recruiting
Gynäkologisch-Onkologische Gemeinschaftspraxis
Braunschweig, Germany
Status: Recruiting
DIAKO Ev. Diakonie-Krankenhaus
Bremen, Germany
Status: Recruiting
Gynaekologicum Bremen
Bremen, Germany
Status: Recruiting
Klinikum Bremen-Mitte
Bremen, Germany
Status: Recruiting
Klinikum Chemnitz
Chemnitz, Germany
Status: Recruiting
Klinikum Darmstadt
Darmstadt, Germany
Status: Recruiting
Donau-Isar-Kliniken, Klinikum Deggendorf
Deggendorf, Germany
Status: Recruiting
Städtisches Klinikum Dessau
Dessau, Germany
Status: Recruiting
Klinikum Dortmund
Dortmund, Germany
Status: Recruiting
Onkozentrum Dresden
Dresden, Germany
Status: Recruiting
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Status: Recruiting
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany
Status: Recruiting
Kaiserswerther Diakonie, Florence-Nightingale-Krankenhaus
Düsseldorf, Germany
Status: Recruiting
Universitätsfrauenklinik Düsseldorf
Düsseldorf, Germany
Status: Recruiting
Rottal-Inn-Klinik Eggenfelden
Eggenfelden, Germany
Status: Recruiting
Universitätsklinikum Erlangen
Erlangen, Germany
Status: Recruiting
Klinikum Essen Mitte
Essen, Germany
Status: Recruiting
Universitätsklinikum Essen
Essen, Germany
Status: Recruiting
Klinikum Esslingen
Esslingen, Germany
Status: Recruiting
DIAKO Flensburg
Flensburg, Germany
Status: Recruiting
Agaplesion Markus Krankenhaus
Frankfurt, Germany
Status: Recruiting
Klinikum Frankfurt Höchst
Frankfurt, Germany
Status: Recruiting
Universitätsklinikum Frankfurt
Frankfurt, Germany
Status: Recruiting
Universitätsfrauenklinik Freiburg
Freiburg, Germany
Status: Recruiting
Kreiskrankenhaus Freudenstadt
Freudenstadt, Germany
Status: Recruiting
Klinikum Fürth
Fürth, Germany
Status: Recruiting
Franziskus-Hospital Harderberg
Georgsmarienhütte, Germany
Status: Recruiting
HELIOS-Klinikum Gifhorn
Gifhorn, Germany
Status: Recruiting
Onkologische Kooperation Harz
Goslar, Germany
Status: Recruiting
Die Frauenarztpraxis in Grafing
Grafing, Germany
Status: Recruiting
Universitätsmedizin Greifswald
Greifswald, Germany
Status: Recruiting
Universitätsklinikum Halle
Halle, Germany
Status: Recruiting
Albertinen Krankenhaus
Hamburg, Germany
Status: Recruiting
Marienkrankenhaus Hamburg
Hamburg, Germany
Status: Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Status: Recruiting
Sana-Klinikum Hameln-Pyrmont
Hameln, Germany
Status: Recruiting
Klinikum Hanau
Hanau, Germany
Status: Recruiting
Friederikenstift
Hannover, Germany
Status: Recruiting
Gynäkologisch-Onkologische Praxis Hannover
Hannover, Germany
Status: Recruiting
Medizinische Hochschule Hannover
Hannover, Germany
Status: Recruiting
Universitätsklinikum Heidelberg
Heidelberg, Germany
Status: Recruiting
Paracelsus-Klinik
Henstedt-Ulzburg, Germany
Status: Recruiting
Praxis Dres. Uleer / Pourfard
Hildesheim, Germany
Status: Recruiting
Klinikum Itzehoe
Itzehoe, Germany
Status: Recruiting
Universitätsklinikum Jena
Jena, Germany
Status: Recruiting
St. Vincentius Kliniken
Karlsruhe, Germany
Status: Recruiting
Klinikum Kassel
Kassel, Germany
Status: Recruiting
Klinikum Kempten
Kempten, Germany
Status: Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Status: Recruiting
Zentrum für Gynäkologische Onkologie
Kiel, Germany
Status: Recruiting
Klinikum Konstanz
Konstanz, Germany
Status: Recruiting
Klinikum Kulmbach
Kulmbach, Germany
Status: Recruiting
St. Elisabeth-Krankenhaus Hohenlind
Köln, Germany
Status: Recruiting
Universitätsklinikum Köln
Köln, Germany
Status: Recruiting
Asklepios Klinik Lich
Lich, Germany
Status: Recruiting
St. Vincenz Krankenhaus
Limburg, Germany
Status: Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Status: Recruiting
Onkologische Schwerpunktpraxis Lüneburg
Lüneburg, Germany
Status: Recruiting
Klinik St. Marienstift
Magdeburg, Germany
Status: Recruiting
Universitätsklinikum Magdeburg
Magdeburg, Germany
Status: Recruiting
Universitätsmedizin Mainz
Mainz, Germany
Status: Recruiting
Universitätsfrauenklinik Mannheim
Mannheim, Germany
Status: Recruiting
Universitätsklinikum Gießen und Marburg
Marburg, Germany
Status: Recruiting
Johannes Wesling Klinikum
Minden, Germany
Status: Recruiting
Klinikum rechts der Isar
München, Germany
Status: Recruiting
LMU München, Frauenklinik Großhadern
München, Germany
Status: Recruiting
Rotkreuzklinikum München
München, Germany
Status: Recruiting
Universitätsklinikum Münster
Münster, Germany
Status: Recruiting
Kliniken des Landkreises Neumarkt
Neumarkt, Germany
Status: Recruiting
Lukaskrankenhaus
Neuss, Germany
Status: Recruiting
MVZ Nordhausen
Nordhausen, Germany
Status: Recruiting
Klinikum Nürnberg
Nürnberg, Germany
Status: Recruiting
Klinikum Offenbach
Offenbach, Germany
Status: Recruiting
Ortenau-Klinikum
Offenburg, Germany
Status: Recruiting
Marienhospital
Osnabrück, Germany
Status: Recruiting
St. Vincenz Krankenhaus
Paderborn, Germany
Status: Recruiting
Onkologische Praxis Pinneberg
Pinneberg, Germany
Status: Recruiting
Harzklinikum Quedlinburg
Quedlinburg, Germany
Status: Recruiting
Onkologie Ravensburg
Ravensburg, Germany
Status: Recruiting
imland Klinik Rendsburg
Rendsburg, Germany
Status: Recruiting
Klinikum am Steinenberg
Reutlingen, Germany
Status: Recruiting
Universitätsfrauenklinik Rostock
Rostock, Germany
Status: Recruiting
Thüringen-Kliniken
Saalfeld, Germany
Status: Recruiting
Caritasklinikum St. Theresia
Saarbrücken, Germany
Status: Recruiting
Praxis Dr. med. W. Dietz
Salzgitter, Germany
Status: Recruiting
Leopoldina-Krankenhaus
Schweinfurt, Germany
Status: Recruiting
HELIOS Kliniken Schwerin
Schwerin, Germany
Status: Recruiting
Diakonie-Klinikum Schwäbisch Hall
Schwäbisch Hall, Germany
Status: Recruiting
Diakonie Klinikum Jung-Stilling
Siegen, Germany
Status: Recruiting
Klinikum Schaumburg, Krankenhaus Stadthagen
Stadthagen, Germany
Status: Recruiting
Klinikum Starnberg
Starnberg, Germany
Status: Recruiting
g.Sund Gyn. Kompetenzzentrum
Stralsund, Germany
Status: Recruiting
Marienhospital Stuttgart
Stuttgart, Germany
Status: Recruiting
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Status: Recruiting
SRH Zentralklinikum Suhl
Suhl, Germany
Status: Recruiting
Kreiskrankenhaus "J. Kentmann"
Torgau, Germany
Status: Recruiting
Klinikum Traunstein
Traunstein, Germany
Status: Recruiting
Klinikum Mutterhaus
Trier, Germany
Status: Recruiting
Universitätsklinikum Tübingen
Tübingen, Germany
Status: Recruiting
Universitätsfrauenklinik Ulm
Ulm, Germany
Status: Recruiting
Praxis Dr. med. W. W. Reiter
Viersen, Germany
Status: Recruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Status: Recruiting
Lahn-Dill-Kliniken Wetzlar
Wetzlar, Germany
Status: Recruiting
Dr. Horst Schmidt Kliniken
Wiesbaden, Germany
Status: Recruiting
St. Josefs Hospital Wiesbaden
Wiesbaden, Germany
Status: Recruiting
amO am Klieversberg
Wolfsburg, Germany
Status: Recruiting
Klinikum Worms
Worms, Germany
Status: Recruiting
Heinrich-Braun-Klinikum
Zwickau, Germany
Status: Recruiting
Gwynedd Hospital
Bangor, United Kingdom
Status: Recruiting
Velindre Cancer Centre
Cardiff, United Kingdom
Status: Recruiting
The Beatson West of Scotland Cancer Center
Glasgow, United Kingdom
Status: Recruiting
Glan Clywd Hospital
Rhyl, United Kingdom
Status: Recruiting
Start Date
May 2013
Completion Date
November 2019
Sponsors
AGO Research GmbH
Source
AGO Research GmbH
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page