Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
NCT ID: NCT00483782
Last Updated: 2013-08-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1520 participants
INTERVENTIONAL
2006-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bevacizumab
carboplatin
paclitaxel
questionnaire administration
study of socioeconomic and demographic variables
quality-of-life assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No planned surgery prior to disease progression, including interval debulking surgery
* Patients with prior early-stage ovarian epithelial or fallopian tube carcinoma treated with surgery alone are eligible at the time of diagnosis of abdominopelvic recurrence provided no further interval cytoreductive therapy is planned prior to disease progression
* Synchronous primary endometrial carcinoma or a past history of primary endometrial carcinoma allowed provided the following criteria are met:
* Disease ≤ stage IB
* No more than superficial myometrial invasion
* No lymphovascular invasion
* Not poorly differentiated (i.e., no grade 3, papillary serous, or clear cell disease)
* Measurable or nonmeasurable disease
* No ovarian nonepithelial cancer, including malignant mixed Müllerian tumors
* No borderline tumors (e.g., tumors of low malignant potential)
* No history or clinical suspicion of brain metastases or spinal cord compression
* CT scan or MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases
* Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL (can be post-transfusion)
* INR ≤ 1.5
* APTT ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* ALT and AST ≤ 2.5 times ULN
* Creatinine ≤ 2.0 mg/dL
* Proteinuria ≤ 1+ by urine dipstick OR ≤ 1 g by 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 weeks after completion of study therapy
* No significant traumatic injury within the past 4 weeks
* No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
* No other malignancies within the past 5 years except for adequately treated carcinoma in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial carcinoma
* No pre-existing sensory or motor neuropathy ≥ grade 2
* No history or evidence of CNS disease (e.g., uncontrolled seizures) by neurological examination unless adequately treated with standard medical therapy
* No history or evidence of thrombotic or hemorrhagic disorders
* No uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg despite antihypertensive therapy)
* No known hypersensitivity to bevacizumab and its excipients, chemotherapy, or Cremophor EL
* No nonhealing wound, ulcer, or bone fracture
* Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations
* No clinically significant cardiovascular disease, including any of the following:
* Myocardial infarction or unstable angina within the past 6 months
* New York Heart Association class II-IV congestive heart failure
* Poorly controlled cardiac arrhythmia despite medication
* Rate-controlled atrial fibrillation allowed
* Peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision)
* No evidence of other disease or condition, metabolic dysfunction, physical examination findings, or laboratory findings that would contraindicate the use of an investigational drug or put the patient at high-risk for treatment-related complications
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since other prior surgery or open biopsy
* No prior systemic therapy for ovarian cancer (e.g., chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy)
* Prior adjuvant chemotherapy allowed for other malignancies (e.g., breast or colorectal carcinoma) if malignancy was diagnosed over 5 years ago with no evidence of subsequent recurrence
* No prior mouse CA 125 antibody
* No prior radiotherapy to the abdomen or pelvis
* More than 10 days since prior and no concurrent chronic use of acetylsalicylic acid (\> 325 mg/day)
* Low-dose (\< 325 mg/day) acetylsalicylic acid allowed
* More than 10 days since prior and no concurrent full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
* Use of therapy for line patency allowed provided INR \< 1.5
* More than 30 days since prior and no other concurrent investigational agent or participation in another clinical trial
* No other concurrent systemic antitumor agents
* No concurrent surgery
* No concurrent maintenance chemotherapy or intraperitoneal chemotherapy (including cytotoxic chemotherapy)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Council
OTHER_GOV
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tim J. Perren, MD
Role: STUDY_CHAIR
Leeds Cancer Centre at St. James's University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia
Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital
Wentworthville, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Royal Women's Hospital
Carlton, Victoria, Australia
Mercy Hospital for Women
East Melbourne, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia
Centre Paul Papin
Angers, , France
Institut Sainte Catherine
Avignon, , France
Institut Bergonie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Louis Pasteur
Colmar, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Institut Prive de Cancerologie
Grenoble, , France
Hopital Andre Mignot
Le Chesnay, , France
Centre Jean Bernard
Le Mans, , France
Centre Leon Berard
Lyon, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre D'Oncologie De Gentilly
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
Hopital Europeen Georges Pompidou
Paris, , France
Institut Curie Hopital
Paris, , France
Hotel Dieu de Paris
Paris, , France
Hopital Cochin
Paris, , France
Hopital Tenon
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Hopital Universitaire Hautepierre
Strasbourg, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Evang. Waldkrankenhaus Spandau
Berlin, , Germany
Charite University Hospital - Campus Virchow Klinikum
Berlin, , Germany
Klinikum Bremen-Mitte
Bremen, , Germany
Praxis Dres. F.& G. Doering
Bremen, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Kreiskrankenhaus
Ebersberg, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Elisabeth-Krankenhaus
Essen, , Germany
Staedtische Kliniken Esslingen
Esslingen am Neckar, , Germany
Onkologie Bethanien
Frankfurt, , Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , Germany
Staedtische Kliniken Frankfurt am Main - Hoechst
Frankfurt, , Germany
Universitaetsfrauenklinik Freiburg
Freiburg im Breisgau, , Germany
Franziskus Hospital Hardenberg
Georgsmarienhütte, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , Germany
Universitaetsklinikum Halle
Halle, , Germany
Henriettenstiftung Frauenklinik
Hanover, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
St. Vincentius - Kliniken
Karlsruhe, , Germany
Klinikum Kassel
Kassel, , Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, , Germany
Kreiskrankenhaus Lahr
Lahr, , Germany
Kreiskrankenhaus Leonberg - Frauenklinik
Leonberg, , Germany
Asklepios Klinik Lich
Lich, , Germany
St. Vincenz Hospital Limburg
Limburg, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, , Germany
Staedtisches Klinikum Lueneburg
Lüneburg, , Germany
Klinik St. Marienstift Magdeburg
Magdeburg, , Germany
St. Vincenz und Elisabeth Hospital
Mainz, , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, , Germany
Klinikum Minden
Minden, , Germany
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
Munich, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, , Germany
Staedtisches Klinikum Neunkirchen gGmbH
Neunkirchen, , Germany
Lukaskrankenhaus Neuss
Neuss, , Germany
Klinikum Offenback GmbH
Offenbach, , Germany
Saint Vincenz-Krankenhaus Paderborn
Paderborn, , Germany
Klinikum Dorothea Christiane Erxleben - Quedlingburg
Quedlinburg, , Germany
Krankenhaus St. Elisabeth - Ravensburg
Ravensburg, , Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, , Germany
Kliniken Landkreis Sigmaringen GMBH
Sigmaringen, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Marienhospital Stuttgart
Stuttgart, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, , Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, , Germany
Marien-Hospital Witten
Witten, , Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, , Germany
Praxis Fuer Haemotologie Und Internistischer Onkologie
Wuppertal, , Germany
Norwegian Radium Hospital
Oslo, , Norway
North Devon District Hospital
Barnstaple, England, United Kingdom
Broomfield Hospital
Broomfield, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Airedale General Hospital
Keighley, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Guy's Hospital
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Hammersmith Hospital
London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Dorset Cancer Centre
Poole Dorset, 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
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
Stoke Mandeville Hospital
Shrewsbury, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Great Western Hospital
Swindon, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Yeovil District Hospital
Yeovil - Somerset, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
South West Wales Cancer Institute
Swansea, Wales, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dhillon S. Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Drugs. 2012 May 7;72(7):917-30. doi: 10.2165/11208940-000000000-00000.
Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stahle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. doi: 10.1056/NEJMoa1103799.
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000548777
Identifier Type: REGISTRY
Identifier Source: secondary_id
EUDRACT-2005-003929-22
Identifier Type: -
Identifier Source: secondary_id
ISRCTN91273375
Identifier Type: -
Identifier Source: secondary_id
ROCHE-MREC-ICON7
Identifier Type: -
Identifier Source: secondary_id
EU-20730
Identifier Type: -
Identifier Source: secondary_id
MREC-06/MRE02/52
Identifier Type: -
Identifier Source: secondary_id
MREC-ICON7
Identifier Type: -
Identifier Source: org_study_id