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Fallopian Tube CancerPhase 3NCT00483782

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

A Phase 3 study testing bevacizumab, carboplatin and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Medical Research Council at 142 sites in 5 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

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
bevacizumab, carboplatin and paclitaxel
Type of treatment
Surgery or procedure
How many people
1,520 participants
Where
142 sitesin 5 countries
Study dates
Apr 2006to not given
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
  • Newly diagnosed disease
  • Meets 1 of the following staging criteria:
  • High-risk stage I or IIA disease (grade 3 disease or clear cell carcinoma only)
  • Stage IIB-IV disease (all grades and all histological types)
  • Must have undergone initial surgery (e.g., debulking cytoreductive surgery or a biopsy if the patient has stage IV disease) within the past 6 weeks
  • Patients with stage IV disease for which initial surgical debulking was not appropriate are eligible provided the following criteria are met:
  • Stage IV disease diagnosed by histology
  • 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)

Trial locations and contacts

142 sites in 5 countries.

142 sites in 5 countries

Germany50 sites

  • Evang. Waldkrankenhaus Spandau

    Berlin, 13589

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

  • Klinikum Bremen-Mitte

    Bremen, D-28205

  • Praxis Dres. F.& G. Doering

    Bremen, D-28205

  • Klinikum Chemnitz gGmbH

    Chemnitz, D-09116

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • Kreiskrankenhaus

    Ebersberg, D-85560

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Elisabeth-Krankenhaus

    Essen, D-45138

  • Staedtische Kliniken Esslingen

    Esslingen am Neckar, D-73730

  • Onkologie Bethanien

    Frankfurt, D-60389

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Staedtische Kliniken Frankfurt am Main - Hoechst

    Frankfurt, D-65929

  • Universitaetsfrauenklinik Freiburg

    Freiburg im Breisgau, D-79106

  • Franziskus Hospital Hardenberg

    Georgsmarienhütte, D-49124

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17487

  • Universitaetsklinikum Halle

    Halle, D-06097

  • Henriettenstiftung Frauenklinik

    Hanover, D-30559

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • St. Vincentius - Kliniken

    Karlsruhe, D-76137

  • Klinikum Kassel

    Kassel, D-34125

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

  • Kreiskrankenhaus Lahr

    Lahr, D-77993

  • Kreiskrankenhaus Leonberg - Frauenklinik

    Leonberg, D-71229

  • Asklepios Klinik Lich

    Lich, D-35423

  • St. Vincenz Hospital Limburg

    Limburg, D-65549

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, D-23538

  • Staedtisches Klinikum Lueneburg

    Lüneburg, D-21339

  • Klinik St. Marienstift Magdeburg

    Magdeburg, D-39110

  • St. Vincenz und Elisabeth Hospital

    Mainz, 55131

  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg

    Marburg, D-35043

  • Klinikum Minden

    Minden, D-32423

  • I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

    Munich, D-80337

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Staedtisches Klinikum Neunkirchen gGmbH

    Neunkirchen, D-66538

  • Lukaskrankenhaus Neuss

    Neuss, D-41464

  • Klinikum Offenback GmbH

    Offenbach, D-63069

  • Saint Vincenz-Krankenhaus Paderborn

    Paderborn, 33098

  • Klinikum Dorothea Christiane Erxleben - Quedlingburg

    Quedlinburg, D-06484

  • Krankenhaus St. Elisabeth - Ravensburg

    Ravensburg, D-88212

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Kliniken Landkreis Sigmaringen GMBH

    Sigmaringen, D-72488

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Marienhospital Stuttgart

    Stuttgart, D-70199

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

  • Marien-Hospital Witten

    Witten, 58452

  • Klinikum der Stadt Wolfsburg

    Wolfsburg, D-38440

  • Praxis Fuer Haemotologie Und Internistischer Onkologie

    Wuppertal, 42105

Other trials in Germany

United Kingdom46 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Centre for Cancer Research and Cell Biology at Queen's University Belfast

    Belfast, Northern Ireland, BT9 7AB

  • Broomfield Hospital

    Broomfield, England, CM1 7ET

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Queen Elizabeth Hospital

    Gateshead, England, NE9 6SX

  • St. Luke's Cancer Centre at Royal Surrey County Hospital

    Guildford, England, GU2 7XX

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Airedale General Hospital

    Keighley, England, BD20 6TD

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • University College of London Hospitals

    London, England, NW1 2PG

  • Guy's Hospital

    London, England, SE1 9RT

  • St. George's Hospital

    London, England, SW17 0QT

  • Hammersmith Hospital

    London, England, W12 OHS

  • Mid Kent Oncology Centre at Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England, CT9 4AN

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Northampton General Hospital

    Northampton, England, NN1 5BD

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Norfolk and Norwich University Hospital

    Norwich, England, NR4 7UY

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

  • Churchill Hospital

    Oxford, England, OX3 7LJ

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Dorset Cancer Centre

    Poole Dorset, England, BH15 2JB

  • Portsmouth Oncology Centre at Saint Mary's Hospital

    Portsmouth Hants, England, PO3 6AD

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Royal Shrewsbury Hospital

    Shrewsbury, England, SY3 8XQ

  • Stoke Mandeville Hospital

    Shrewsbury, England, SY3 8XQ

  • Wexham Park Hospital

    Slough, Berkshire, England, SL2 4HL

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • South West Wales Cancer Institute

    Swansea, Wales, SA2 8QA

  • Great Western Hospital

    Swindon, England, SN3 6BB

  • Royal Cornwall Hospital

    Truro, Cornwall, England, TR1 3LJ

  • Yeovil District Hospital

    Yeovil - Somerset, England, BA21 4AT

Other trials in United Kingdom

France29 sites

  • Centre Paul Papin

    Angers, 49100

  • Institut Sainte Catherine

    Avignon, 84082

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Clinique Tivoli

    Bordeaux, F-33000

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur

    Colmar, 68024

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Institut Prive de Cancerologie

    Grenoble, 38100

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Jean Bernard

    Le Mans, 72000

  • Centre Leon Berard

    Lyon, 69373

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Centre D'Oncologie De Gentilly

    Nancy, 54100

  • Centre Catherine de Sienne

    Nantes, 02

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Institut Curie Hopital

    Paris, 75020

  • Hotel Dieu de Paris

    Paris, 75181

  • Hopital Cochin

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Henri Becquerel

    Rouen, 76038

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia16 sites

  • Royal Adelaide Hospital Cancer Centre

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Royal Women's Hospital

    Carlton, Victoria, 3053

  • Mercy Hospital for Women

    East Melbourne, Victoria, 3002

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Cancer Therapy Centre at Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Sir Charles Gairdner Hospital - Perth

    Perth, Western Australia, 6009

  • Prince of Wales Private Hospital

    Randwick, New South Wales, 2031

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales, 2298

  • Westmead Institute for Cancer Research at Westmead Hospital

    Wentworthville, New South Wales, 2145

  • Murray Valley Private Hospital and Cancer Treatment Centre

    Wodonga, Victoria, 3690

Other trials in Australia

Norway1 site

  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

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.

Read the 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.

Being tested
bevacizumab, carboplatin, paclitaxel, questionnaire administration, study of socioeconomic and demographic variables
Keywords
stage IV ovarian epithelial cancer, Brenner tumor, ovarian carcinosarcoma, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IA fallopian tube cancer, stage IB fallopian tube cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Brenner Tumor

What participants receive

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

  • bevacizumabBiological

  • carboplatinDrug

  • paclitaxelDrug

  • questionnaire administrationOther

  • study of socioeconomic and demographic variablesOther

  • quality-of-life assessmentProcedure or surgery

What is being measured

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

  1. Progression-free survival

Secondary outcomes (7)

  1. Duration of overall survival

  2. Objective response rate

  3. Duration of response

  4. Biological progression-free interval as measured by increasing CA 125 levels

  5. Safety as measured by NCI CTAE version 3.0

  6. Quality of life

  7. Health economics

Timeline

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

  1. First posted7 Jun 2007 (estimated)
  2. Study startApr 2006

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
Masking
None (open label)
Enrolment
1,520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00483782
Sponsor's protocol ID
MREC-ICON7
Other IDs
CDR0000548777, EUDRACT-2005-003929-22, ISRCTN91273375, ROCHE-MREC-ICON7, EU-20730, MREC-06/MRE02/52
Status last verified
Apr 2012
First submitted
6 Jun 2007
Last updated
12 Aug 2013
Results posted
No

Publications

  • 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.

    PubMed 22515620

  • 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.

    PubMed 22204725

  • 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.

    PubMed 37185961

  • 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.

    PubMed 21941283

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab, carboplatin and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Medical Research Council at 142 sites in 5 countries.

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

Who may be eligible to take part?

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 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in Germany, United Kingdom, France, Australia, Norway. 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?

Progression-free survival. 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 NCT00483782, which also lists 4 linked publications.

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 12 Aug 2013.

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