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Genital Diseases, FemalePhase 3BOOSTNCT01462890

Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Genital Diseases, Female and Ovarian Diseases, run by AGO Study Group at 131 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

The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
927 participants
Where
131 sitesin 6 countries
Study dates
Nov 2011to Dec 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

  • Signed written informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements
  • Primary diagnosis is confirmed by specialized pathology review (Germany only)
  • Females aged ≥ 18 years
  • Histologically confirmed, newly diagnosed
  • Epithelial ovarian carcinoma
  • Fallopian tube carcinoma
Show all 25Show fewer
  • Primary peritoneal carcinoma AND FIGO stage IIb - IV (all grades and all histological types)
  • Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in whom initial surgical debulking was not appropriate or possible will still be eligible providing
  • the patient has a histological diagnosis and
  • debulking surgery prior to disease progression is not foreseen
  • Patients must be able to commence cytotoxic chemotherapy within 8 weeks of cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks of surgery.
  • ECOG 0-2
  • Life expectancy > 3 months
  • Adequate bone marrow function (within 14 days prior to randomization)
  • ANC ≥ 1.5 x 10^9/L
  • PLT ≥ 100 x 10^9/L
  • Hb ≥ 9 g/dL (can be post-transfusion)
  • Adequate coagulation parameters (within 14 days prior to randomization)
  • Patients not receiving anticoagulant medication who have an INR ≤ 1.5 and an aPTT ≤ 1.5 x ULN
  • The use of full-dose oral or par-enteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of randomization.
  • Adequate liver function (within 14 days prior to randomization)
  • Serum bilirubin ≤ 1.5 x ULN
  • Serum transaminases ≤ 2.5 x ULN
  • Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours
  • Adequate postoperative GFR > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula are sufficient)

Who cannot join

  • Non-epithelial origin of the ovary, the fallopian tube or the peritoneum
  • Borderline tumours (tumours of low malignant potential) and FIGO stage Ia - IIa tumours
  • Planned intraperitoneal cytotoxic chemotherapy
  • Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
  • Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from the first cycle of chemotherapy). It is strongly recommended that an interval of 7 days is left between the insertion of any central venous access devices (CVADs) and the onset of bevacizumab treatment.
  • Any planned surgery during the study treatment period plus 4 additional weeks to allow for bevacizumab clearance
Show all 34Show fewer
  • Uncontrolled hypertension (sustained elevation of BP systolic > 150mmHg and/or diastolic > 100mmHg despite antihypertensive therapy)
  • Any previous radiotherapy to the abdomen or pelvis
  • Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab
  • History or clinical suspicion of brain metastases or spinal cord compression. CT/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.
  • History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures
  • Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomization
  • 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 study duration and at least 6 months afterwards
  • Pregnant or lactating women
  • Treatment with other investigational agents, or participation in another clinical trial testing a drug within the past 4 weeks before start of therapy concomitantly with this trial
  • Malignancies other than ovarian cancer within 5 years prior to randomization, except for adequately treated
  • carcinoma in situ of the cervix
  • and/or basal cell skin cancer
  • and/or non-melanomatous skin cancer
  • carcinoma in situ of the breast
  • and/or early endometrial carcinoma as specified below. Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago with no evidence of subsequent recurrence.
  • Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met
  • Disease stage FIGO stage ≤ IA (tumour invades less than one half of the myometrium)
  • Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell products or other recombinant human or humanised antibodies
  • Non healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations
  • History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
  • Clinically significant cardiovascular disease, including
  • Myocardial infarction or unstable angina within 6 months of randomization
  • NYHA ≥ Grade 2 Congestive Heart Failure (CHF)
  • Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)
  • Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activities of daily living requiring repair or revision)
  • Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day
  • Pre-existing sensory or motor neuropathy ≥ Grade 2
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

Trial locations and contacts

131 sites in 6 countries.

131 sites in 6 countries

Germany86 sites

  • Study site

    Aachen

  • Study site

    Arnsberg

  • Study site

    Aschaffenburg

  • Study site

    Augsburg

  • Study site

    Bad Homburg

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Bonn

  • Study site

    Bottrop

  • Study site

    Brandenburg

  • Study site

    Bremen

  • Study site

    Chemnitz

  • Study site

    Coburg

  • Study site

    Cologne

  • Study site

    Deggendorf

  • Study site

    Dessau

  • Study site

    Dresden

  • Study site

    Düsseldorf

  • Study site

    Ebersberg

  • Study site

    Eggenfelden

  • Study site

    Erlangen

  • Study site

    Essen

  • Study site

    Esslingen am Neckar

  • Study site

    Flensburg

  • Study site

    Frankfurt/M.

  • Study site

    Freiburg im Breisgau

  • Study site

    Fürstenfeldbruck

  • Study site

    Fürth

  • Study site

    Georgsmarienhütte

  • Study site

    Gera

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Gütersloh

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Hanau

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Henstedt-Ulzburg

  • Study site

    Hildesheim

  • Study site

    Jena

  • Study site

    Kaiserslautern

  • Study site

    Karlsruhe

  • Study site

    Kassel

  • Study site

    Kiel

  • Study site

    Krefeld

  • Study site

    Lich

  • Study site

    Limburg

  • Study site

    Lübeck

  • Study site

    Lüneburg

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Mannheim

  • Study site

    Marburg

  • Study site

    Minden

  • Study site

    München

  • Study site

    Neumarkt

  • Study site

    Neuss

  • Study site

    Nordhausen

  • Study site

    Offenbach

  • Study site

    Offenburg

  • Study site

    Oldenburg

  • Study site

    Osnabrück

  • Study site

    Ravensburg

  • Study site

    Regensburg

  • Study site

    Reutlingen

  • Study site

    Rosenheim

  • Study site

    Rostock

  • Study site

    Rottweil

  • Study site

    Saalfeld

  • Study site

    Salzgitter

  • Study site

    Schwäbisch Hall

  • Study site

    Schweinfurt

  • Study site

    Sigmaringen

  • Study site

    Solingen

  • Study site

    Stralsund

  • Study site

    Stuttgart

  • Study site

    Torgau

  • Study site

    Trier

  • Study site

    Tübingen

  • Study site

    Ulm

  • Study site

    Viersen

  • Study site

    Wiesbaden

  • Study site

    Witten

  • Study site

    Wolfsburg

  • Study site

    Worms

Other trials in Germany

France33 sites

  • Study site

    Angers

  • Study site

    Besançon

  • Study site

    Blois

  • Study site

    Bordeaux

  • Study site

    Caen

  • Study site

    Cahors

  • Study site

    Clamart

  • Study site

    Clermont-Ferrand

  • Study site

    Créteil

  • Study site

    Dax

  • Study site

    Draguignan

  • Study site

    Grenoble

  • Study site

    Limoges

  • Study site

    Lyon

  • Study site

    Mougins

  • Study site

    Nancy

  • Study site

    Nantes

  • Study site

    Nice

  • Study site

    Nîmes

  • Study site

    Orléans

  • Study site

    Paris

  • Study site

    Pau

  • Study site

    Plérin

  • Study site

    Poitiers

  • Study site

    Quimper

  • Study site

    Reims

  • Study site

    Rouen

  • Study site

    Saint-Herblain

  • Study site

    Strasbourg

  • Study site

    Toulouse

  • Study site

    Vandœuvre-lès-Nancy

  • Study site

    Vannes

  • Study site

    Villejuif

Other trials in France

Finland4 sites

  • Study site

    Kuopio

  • Study site

    Oulu

  • Study site

    Tampere

  • Study site

    Turku

Other trials in Finland

Denmark3 sites

  • Study site

    Aalborg

  • Study site

    Copenhagen

  • Study site

    Herlev

Other trials in Denmark

Norway3 sites

  • Study site

    Bergen

  • Study site

    Oslo

  • Study site

    Trondheim

Other trials in Norway

Sweden2 sites

  • Study site

    Falun

  • Study site

    Uppsala

Other trials in Sweden

About this study

Official title: A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.

Read the detailed description

Determination whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months

Being tested
Bevacizumab, Paclitaxel, Carboplatin, specialized pathology review (Germany only)
Keywords
Ovarian Carcinoma, Bevacizumab, Paclitaxel, Carboplatin
Medical subject headings
Genital Diseases, Female, Ovarian Diseases, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

What participants receive

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

  • BevacizumabBiological

    15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44

  • PaclitaxelDrug

    175 mg/m², iv on day 1 every 3 weeks for 6 cycles

  • CarboplatinDrug

    AUC 5, iv on day 1 every 3 weeks for 6 cycles

  • specialized pathology review (Germany only)Other

    before randomization

Study groups in NCT01462890
Study groupRoleWhat they receive
Control ArmOtherPatients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab iv alone every 3 weeks for 16 cycles.
Receives: Biological: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin; Other: specialized pathology review (Germany only)
Research ArmExperimentalPatients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab iv alone every 3 weeks for 38 cycles.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Other: specialized pathology review (Germany only)

What is being measured

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

  1. Progression Free Survival (PFS)

    Measured: every 12 weeks until progression or up to 30 months, thereafter every 6 months

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Measured: every 12 weeks until progression or up to 30 months, thereafter every 6 months

  2. Overall survival (OS)

    Measured: every 3 weeks, 31 months after start of treatment, thereafter every 6 months

  3. Health related Quality of life (QoL)

    Measured: baseline, then every 12 weeks until progression, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)

  4. Safety and tolerability, i.e. type, frequency, severity and duration of adverse reactions

    Measured: every 3 weeks, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)

  5. Translational Research - Tumor Tissue Block

    may be obtained at any time during therapy, preferably at cycle 1 or at a subsequent visit

    Measured: Assessment at end of study planned

  6. Translational Research - Complementary and Alternative Treatment Questionnaires

    Measured: baseline, 6 months and 12 months after start of treatment, if required at timepoint of treatment termination

Timeline

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

  1. First posted1 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completion31 Dec 2020
  4. Study completionDec 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
Model description
Randomized Phase III study
Masking
None (open label)
Enrolment
927 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462890
Sponsor's protocol ID
AGO-OVAR 17
Acronym
BOOST
Status last verified
Jul 2022
First submitted
25 Oct 2011
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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

  • Pfisterer J, Joly F, Kristensen G, Rau J, Mahner S, Pautier P, El-Balat A, Kurtz JE, Canzler U, Sehouli J, Heubner ML, Hartkopf AD, Baumann K, Hasenburg A, Hanker LC, Belau A, Schmalfeldt B, Denschlag D, Park-Simon TW, Selle F, Jackisch C, Burges A, Luck HJ, Emons G, Meier W, Gropp-Meier M, Schroder W, de Gregorio N, Hilpert F, Harter P. Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial. J Clin Oncol. 2023 Feb 1;41(4):893-902. doi: 10.1200/JCO.22.01010. Epub 2022 Nov 4.

    PubMed 36332161

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Genital Diseases, Female and Ovarian Diseases, run by AGO Study Group at 131 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 25 inclusion and 34 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in Germany, France, Finland, Denmark, Norway 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?

Progression Free Survival (PFS) (time frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months). 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 NCT01462890, which also lists 2 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 20 Jul 2022.

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