Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00483782
- Lead Sponsor
- Medical Research Council
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the progression-free survival and overall survival of patients with newly diagnosed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with carboplatin and paclitaxel with vs without bevacizumab.
Secondary
* Compare the response rate in patients treated with these regimens.
* Compare the duration of tumor response in patients treated with these regimens.
* Compare the biological progression-free interval, as measured by increasing CA 125 levels, in patients treated with these regimens.
* Compare the safety (e.g., adverse events, laboratory results, and performance status) of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the cost-effectiveness of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized, controlled study. Patients are stratified according to FIGO stage (stage I-III with residual disease ≤ 1 cm vs stage I-III with residual disease \> 1 cm vs stage IV disease), intended time to start chemotherapy after surgery (≤ 4 weeks vs \> 4 weeks), and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I (control): Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive bevacizumab IV over 30-90 minutes followed by paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab alone every 3 weeks for 12 courses.
Quality of life is assessed at baseline, before every course, every 6 weeks for 1 year, every 3 months until disease progression or for up to 2 years, and then at 3 years. Health economic data is assessed periodically, including days of inpatient hospitalization visits, outpatient visits, and use of anticancer therapies.
After completion of study treatment, patients are followed every 3-6 months for 5 years and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1520
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Duration of overall survival Objective response rate Duration of response Biological progression-free interval as measured by increasing CA 125 levels Safety as measured by NCI CTAE version 3.0 Quality of life Health economics
Trial Locations
- Locations (142)
Cancer Therapy Centre at Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
St. George's Hospital
🇬🇧London, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
🇬🇧Hull, England, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Stoke Mandeville Hospital
🇬🇧Shrewsbury, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Airedale General Hospital
🇬🇧Keighley, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint Herblain, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Institut Curie Hopital
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Franziskus Hospital Hardenberg
🇩🇪Georgsmarienhuette, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Universitaetsklinikum Halle
🇩🇪Halle, Germany
St. Vincentius - Kliniken
🇩🇪Karlsruhe, Germany
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Paul Papin
🇫🇷Angers, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Newcastle Mater Misericordiae Hospital
🇦🇺Waratah, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Adelaide Hospital Cancer Centre
🇦🇺Adelaide, South Australia, Australia
Sir Charles Gairdner Hospital - Perth
🇦🇺Perth, Western Australia, Australia
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Institut Sainte Catherine
🇫🇷Avignon, France
Institut Prive de Cancerologie
🇫🇷Grenoble, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Klinikum Bremen-Mitte
🇩🇪Bremen, Germany
Praxis Dres. F.& G. Doering
🇩🇪Bremen, Germany
Centre Jean Bernard
🇫🇷Le Mans, France
Institut Bergonie
🇫🇷Bordeaux, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Centre D'Oncologie De Gentilly
🇫🇷Nancy, France
Mercy Hospital for Women
🇦🇺East Melbourne, Victoria, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Universitatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Clinique Tivoli
🇫🇷Bordeaux, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Centre Henri Becquerel
🇫🇷Rouen, France
Evang. Waldkrankenhaus Spandau
🇩🇪Berlin, Germany
Charite University Hospital - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Universitaetsfrauenklinik Freiburg
🇩🇪Freiburg, Germany
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
Staedtische Kliniken Frankfurt am Main - Hoechst
🇩🇪Frankfurt, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Kreiskrankenhaus Leonberg - Frauenklinik
🇩🇪Leonberg, Germany
St. Vincenz Hospital Limburg
🇩🇪Limburg, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
🇩🇪Luebeck, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Kliniken Landkreis Sigmaringen GMBH
🇩🇪Sigmaringen, Germany
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
🇩🇪Munich, Germany
Staedtisches Klinikum Neunkirchen gGmbH
🇩🇪Neunkirchen, Germany
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Kreiskrankenhaus Lahr
🇩🇪Lahr, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Klinikum Minden
🇩🇪Minden, Germany
Praxis Fuer Haemotologie Und Internistischer Onkologie
🇩🇪Wuppertal, Germany
Asklepios Klinik Lich
🇩🇪Lich, Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
🇩🇪Marburg, Germany
St. Vincenz und Elisabeth Hospital
🇩🇪Mainz, Germany
Lukaskrankenhaus Neuss
🇩🇪Neuss, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Marienhospital Stuttgart
🇩🇪Stuttgart, Germany
Krankenhaus St. Elisabeth - Ravensburg
🇩🇪Ravensburg, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Klinikum Offenback GmbH
🇩🇪Offenbach, Germany
Marien-Hospital Witten
🇩🇪Witten, Germany
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Norwegian Radium Hospital
🇳🇴Oslo, Norway
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
Hammersmith Hospital
🇬🇧London, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Royal Women's Hospital
🇦🇺Carlton, Victoria, Australia
Henriettenstiftung Frauenklinik
🇩🇪Hannover, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Hotel Dieu de Paris
🇫🇷Paris, France
Yeovil District Hospital
🇬🇧Yeovil - Somerset, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Murray Valley Private Hospital and Cancer Treatment Centre
🇦🇺Wodonga, Victoria, Australia
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Onkologie Bethanien
🇩🇪Frankfurt, Germany
Staedtische Kliniken Esslingen
🇩🇪Esslingen, Germany
Staedtisches Klinikum Lueneburg
🇩🇪Lueneburg, Germany
Kreiskrankenhaus
🇩🇪Ebersberg, Germany
Elisabeth-Krankenhaus
🇩🇪Essen, Germany
Klinik St. Marienstift Magdeburg
🇩🇪Magdeburg, Germany
Klinikum Dorothea Christiane Erxleben - Quedlingburg
🇩🇪Quedlinburg, Germany
Saint Vincenz-Krankenhaus Paderborn
🇩🇪Paderborn, Germany
Klinikum der Stadt Wolfsburg
🇩🇪Wolfsburg, Germany
Broomfield Hospital
🇬🇧Broomfield, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Churchill Hospital
🇬🇧Oxford, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Hopital Cochin
🇫🇷Paris, France
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Great Western Hospital
🇬🇧Swindon, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom