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Recurrent Ovarian CancerPhase 3MITO16MANGO2bNCT01802749

Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Recurrent Ovarian Cancer, run by National Cancer Institute, Naples at 82 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Ovarian Cancer
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
406 participants
Where
82 sitesin 5 countries
Study dates
Nov 2013to Dec 2023
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

  • Female patients ≥18 years of age.
  • Patients with histologically confirmed epithelial ovarian or fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours
  • Recurrence or progression at least 6 months after the last chemotherapy cycle of a first line carboplatin + paclitaxel chemotherapy including bevacizumab (recurrence or progression might occur either during or after bevacizumab as maintenance)
  • Patients can be included if they have a RECIST progression, with either measurable or non-measurable disease
  • ECOG (Eastern Cooperative Oncology Group Performance) Status of 0-2.
  • Life expectancy of at least 12 weeks.
  • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements including blood samples for molecular analyses.
  • Availability of tumour samples for molecular analyses from primary surgery (mandatory) and secondary surgery (when available)

Who cannot join

  • Cancer related
  • Ovarian tumours with low malignant potential (i.e. borderline tumours)
  • History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
  • stage ≤Ia
  • no more than superficial myometrial invasion
  • no lymphovascular invasion
Show all 37Show fewer
  • not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).
  • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
  • Prior current or planned treatment:
  • More than one previous chemotherapy line
  • Previous therapy with other anti-angiogenetic agents different from bevacizumab.
  • Any prior radiotherapy to the pelvis or abdomen.
  • Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose.Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes (except for line patency, in which case international normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed.
  • Current or recent (within 30 days of first study dosing) treatment with any other investigational drug.
  • Laboratory:
  • Inadequate bone marrow function: ANC (absolute neutrophil count): <1500/mm3, or platelet count <100,000/mm3 or Haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9 g/dl.
  • Inadequate coagulation parameters:
  • activated partial thromboplastin time (APTT) >1.5 x upper limit of normal (ULN) or
  • INR (international normalized ratio) >1.5
  • Inadequate liver function, defined as:
  • serum (total) bilirubin >1.5 x ULN for the institution
  • AST/SGOT or ALT/SGPT > 2.5 x ULN.
  • Inadequate renal function, defined as:
  • serum creatinine >2.0 mg/dl or >177 micromol/l
  • urine dipstick for proteinuria >2+. Patients with ≥ 1+ proteinuria at baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in their 24-hour urine collection.
  • Prior or concomitant conditions or procedures:
  • History or evidence of brain metastases or spinal cord compression.
  • Pregnant or lactating females.
  • History or evidence of thrombotic or haemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within ≤6 months prior to the first study treatment).
  • Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including:
  • myocardial infarction or unstable angina within ≤6 months prior to the first study treatment
  • New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF)
  • serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia)
  • peripheral vascular disease ≥grade 3 (i.e. symptomatic and interfering with activities of daily living requiring repair or revision).
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, or with signs of impending bowel obstruction within 6 months prior to the first study treatment.
  • Non-healing 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.
  • Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.

Trial locations and contacts

82 sites in 5 countries.

82 sites in 5 countries

Italy36 sites

  • Centro di Riferimento Oncologico

    Aviano

  • A.O. G. Rummo

    Benevento

  • Spedali Civili Università di Brescia

    Brescia

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • Fondazione del Piemonte per l'Oncologia IRCCS

    Candiolo

  • Osp. Cannizzaro

    Catania

  • Ospedale Civile di Faenza

    Faenza

  • I.R.C.C.S. San Martino IST

    Genova

  • Ospedale Galliera

    Genova

  • ASL 5 Spezzino Ospedale Felettino

    La Spezia

  • A.O. Vito Fazzi

    Lecce

  • Ospedale Manzoni di Lecco

    Lecco

  • Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • Istituto Europeo di Oncologia

    Milan

  • Istituto Nazionale Tumori

    Milan

  • U.L.S.S. 13

    Mirano

  • A.O.U. Federico II

    Naples

  • A.O.U. Seconda Università di Napoli

    Naples

  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

    Naples

  • Ist. Sacro Cuore Don Calabria

    Negrar

  • NO AOU Maggiore della Carità

    Novara

  • Istituto Oncologico Veneto

    Padova

  • Casa di Cura La Maddalena

    Palermo

  • Osp Silvestrini

    Perugia

  • Ospedale Santa Chiara

    Pisa

  • A.O. S. Maria degli Angeli

    Pordenone

  • AO ASL 4

    Prato

  • Ospedale S. Maria delle Croci AUSL di Ravenna

    Ravenna

  • Arcispedale S. Maria Nuova

    Reggio Emilia

  • Ospedale Civile Rimini

    Rimini

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma

  • Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

    Roma

  • Policlinico Università Campus Biomedico

    Roma

  • Ospedale di Sondrio

    Sondrio

  • A.O. Ordine Mauriziano

    Torino

  • A.O. di Udine S. Maria della Misericordia

    Udine

Other trials in Italy

France29 sites

  • Centre Hospitalier d'Aix-en-Provence

    Aix-en-Provence

  • Hôpital de la Côte Basque

    Bayonne

  • Institut Bergoniè

    Bordeaux

  • Hôpital Fleyriat

    Bourg-en-Bresse

  • Centre François Baclesse

    Caen

  • Centre Hospitalier Intercommunal de Créteil

    Créteil

  • Centre d'Oncologie et de Radiothérapie

    Dijon

  • Centre Georges Francois Leclerc

    Dijon

  • Centre Hospitalier du Mans

    Le Mans

  • Centre Hospitalier Universitaire Dupuytren

    Limoges

  • Centre Léon Bérard

    Lyon

  • Clinique de la Sauvegarde

    Lyon

  • Hôpital Nord

    Marseille

  • Hôpital Saint-Joseph

    Marseille

  • Clinique Claude Bernard

    Metz

  • Centre Azuréen de Cancérologie

    Mougins

  • Centre Hospitalier Général de Pau

    Paris

  • Hopital Cochin

    Paris

  • Hôpital des Diaconesses

    Paris

  • Hôpital Tenon

    Paris

  • Centre Hospitalier Général de Pau

    Pau

  • Centre Hospitalier de la Région d'Annecy

    Pringy

  • Institut Jean Godinot

    Reims

  • Hopital Renè Huguenin, Institut Curie

    Saint-Cloud

  • Hôpital Inter Armées de Begin (HIA Begin),

    Saint-Mandé

  • GHPSO

    Senlis

  • Centre de Radiothèrapie - Clinique Sainte-Anne

    Strasbourg

  • Clinique des Dentellières,

    Valenciennes

  • Institut de Cancérologie Gustave Roussy

    Villejuif

Other trials in France

Switzerland12 sites

  • Zentrum fùr Onkologie/ Hamat. und Transf

    Aarau

  • Universitatsspital,Frauenklinik

    Basel

  • IOSI

    Bellinzona

  • Klinik Engeried

    Bern

  • Kantonsspital

    Chur

  • Kantonsspital

    Frauenfeld

  • HUG Breast Center

    Geneva

  • Kantonsspital

    Lucerne

  • Kantonsspital

    Münsterlingen

  • Kantonsspital

    Olten

  • Klinische Forschung Onkologie

    Sankt Gallen

  • Kantonsspital

    Winterthur

Other trials in Switzerland

Greece4 sites

  • Anticancer Hospital Agio Savvas

    Athens

  • General Hospital of Athens Alexandra

    Athens

  • General Oncology Hospital Agii Anargiri

    Athens

  • General Hospital of Thessaloniki Papageorgiou

    Thessaloniki

Other trials in Greece

Monaco1 site

  • Centre Hospitalier Princesse Grace

    Monaco

Other trials in Monaco

About this study

Official title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

Being tested
Bevacizumab, Paclitaxel, Carboplatin, pegylated liposomal doxorubicin, Gemcitabine
Keywords
second line, platinum sensitive, first line bevacizumab, biologic factors, clinical factors
Medical subject headings
Ovarian Neoplasms

What participants receive

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

Study groups in NCT01802749
Study groupRoleWhat they receive
chemotherapyActive comparatorCombination chemotherapy with ONE of the following regimens: * PLD-C: Pegylated liposomal doxorubicin 30 mg/m2 + Carboplatin AUC (area under curve) 5 on day 1 every 4 weeks; * GEM-C: Gemcitabine 1000 mg/m2 on day 1, 8 every 21 + Carboplatin AUC of 4 on day 1 every 21 days; * PAC-C: Paclitaxel 175 mg/m2 on day 1, every 21 + Carboplatin AUC of 5 on day 1 every 21 days.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: pegylated liposomal doxorubicin; Drug: Gemcitabine
Chemotherapy and bevacizumabExperimentalCombination chemotherapy AND bevacizumab with ONE of the following regimens: * PLD-C: Pegylated liposomal doxorubicin 30 mg/m2 + Carboplatin AUC 5 on day 1 every 4 weeks and Bevacizumab 10 mg/kg i.v. on Day 1 every 2 weeks; * GEM-C: Gemcitabine 1000 mg/m2 on day 1, 8 every 21 + Carboplatin AUC of 4 on day 1 every 21 days AND Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks;L * PAC-C: Paclitaxel 175 mg/m2 on day 1, every 21 + Carboplatin AUC of 5 on day 1 every 21 days AND Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks. Patients whose disease has not progressed after the initial six cycles of combination treatment will continue bevacizumab, at 15 mg/kg every 3 weeks until disease progression,unacceptable toxicity or patient withdrawn.
Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin; Drug: pegylated liposomal doxorubicin; Drug: Gemcitabine

What is being measured

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

  1. progression free survival

    assessed by local Investigator

    Measured: 12 months

Secondary outcomes (6)

  1. overall survival

    Measured: 12 months

  2. number of complete or partial responses

    according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 6 months

  3. worst grade toxicity per patient

    according to Common Toxicity Criteria for Adverse Events v. 4.03

    Measured: evaluated every 3 weeks up to 12 months

  4. number of patients taking oral antidiabetic therapy

    Measured: at baseline

  5. number of patients taking antithrombotic therapy

    Measured: at baseline

  6. progression free survival

    as measured by independent central review

    Measured: 12 months

Timeline

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

  1. First posted1 Mar 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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
Masking
None (open label)
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01802749
Sponsor's protocol ID
MITO-16 -MANGO-OV2b
Other IDs
2012-004362-17, ENGOT-ov 17
Acronym
MITO16MANGO2b
Status last verified
Mar 2023
First submitted
27 Feb 2013
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes

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

  • Pignata S, Lorusso D, Joly F, Gallo C, Colombo N, Sessa C, Bamias A, Salutari V, Selle F, Frezzini S, De Giorgi U, Pautier P, Bologna A, Orditura M, Dubot C, Gadducci A, Mammoliti S, Ray-Coquard I, Zafarana E, Breda E, Favier L, Ardizzoia A, Cinieri S, Largillier R, Sambataro D, Guardiola E, Lauria R, Pisano C, Raspagliesi F, Scambia G, Daniele G, Perrone F; MITO16b/MANGO-OV2/ENGOT-ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):267-276. doi: 10.1016/S1470-2045(20)30637-9.

    PubMed 33539744

  • Arend R, Westin SN, Coleman RL. Decision analysis for secondline maintenance treatment of platinum sensitive recurrent ovarian cancer: a review. Int J Gynecol Cancer. 2020 May;30(5):684-694. doi: 10.1136/ijgc-2019-001041. Epub 2020 Feb 19.

    PubMed 32079709

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Recurrent Ovarian Cancer, run by National Cancer Institute, Naples at 82 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?

The sponsor lists 8 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Italy, France, Switzerland, Greece, Monaco. 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?

Results are not available in the source record.

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 (time frame: 12 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 NCT01802749, which also lists 3 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 24 Mar 2023.

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