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Ovarian CancerPhase 4MITO16/MANGO-2NCT01706120

Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab

A Phase 4 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by National Cancer Institute, Naples at 47 sites in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
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
400 participants
Where
47 sitesItaly
Study dates
Oct 2012to Dec 2024
Phase
Phase 4
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 carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone.
  • FIGO stage IIIB \& C or IV
  • ECOG 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.
  • Availability of tumour samples for molecular analyses

Who cannot join

  • Cancer related
  • Ovarian tumours with low malignant potential (i.e. borderline tumours)
  • Previous systemic anti-cancer therapy for advanced ovarian cancer.
  • History or evidence of brain metastases or spinal cord compression.
  • History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
  • stage ≤Ia
Show all 36Show fewer
  • no more than superficial myometrial invasion
  • no lymphovascular invasion
  • 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.
  • Other-treatment related
  • Any prior radiotherapy to the pelvis or abdomen.
  • Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or planned (In this case the patient can be enrolled but the administration of bevacizumab should be omitted at first cycle).
  • Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for central venous access 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 another investigational drug.
  • Laboratory related
  • Inadequate bone marrow function: ANC: <1.5 x 109/l, or platelet count <100 x 109/l 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 xULN or
  • INR >1.5
  • Inadequate liver function, defined as:
  • serum (total) bilirubin >1.5 x the upper limit of normal (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
  • Proteinuria >1g in a 24-hour urine collection (to be performed only among patients who showed a ≥3+ at urine dipstick).
  • Patient related
  • Pregnant or lactating patients.
  • History or evidence of thrombotic or hemorrhagic 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 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 fascial 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

47 sites in 1 country.

47 sites in 1 country

Italy47 sites

  • A.S.O. SS Antonio e Biagio e Cesare Arrigo

    Alessandria

  • Centro di Riferimento Oncologico

    Aviano

  • Ospedale Fatebenefratelli

    Benevento

  • Spedali Civili - Università di Brescia

    Brescia

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • Fondazione del Piemonte per l'Oncologia

    Candiolo

  • Ospedale Ramazzini di Carpi /Ospedale di Mirandola

    Carpi

  • Azienda Ospedaliera Garibaldi Nesimadi Catania

    Catania

  • Ospedale Cannizzaro

    Catania

  • Ospedale Mater Domini

    Catanzaro

  • Ospedale Civile di Faenza

    Faenza

  • Ospedale Santa Croce

    Fano

  • A.O.U. Arcispedale Sant'Anna di Ferrara

    Ferrara

  • Ospedale Fabrizio Spaziani di Frosinone / Osp. SS Trinità di Sora

    Frosinone

  • E.O. Ospedali Galliera

    Genova

  • IRCCS San Martino IST

    Genova

  • Ospedale di Guastalla

    Guastalla

  • Ospedale A. Manzoni

    Lecco

  • Ospedale Mater Salutis

    Legnago

  • Presidio Ospedaliero Manerbio

    Manerbio

  • A.O. C. Poma

    Mantua

  • Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • Istituto Europeo di Oncologia

    Milan

  • Istituto Nazionale Tumori

    Milan

  • Ospedale San Raffaele

    Milan

  • U.L.S.S. 13

    Mirano

  • A.O.U. Policlinico Modena

    Modena

  • Ospedale S. Gerardo

    Monza

  • AOU Policlinico Federico II

    Naples

  • Istituto Nazionale dei Tumori

    Naples

  • Istituto Sacro Cuore Don Calabria

    Negrar

  • Istituto Oncologico Veneto

    Padova

  • Fondazione IRCCS S. Matteo

    Pavia

  • Ospedale Silvestrini

    Perugia

  • Ospedale Santa Chiara

    Pisa

  • A.O. Santa Maria degli Angeli

    Pordenone

  • Ospedale S. Maria delle Croci

    Ravenna

  • Arcispedale S. Maria Nuova

    Reggio Emilia

  • Ospedale degli Infermi / Ospedale Civile

    Rimini

  • Istituto Regina Elena

    Roma

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma

  • Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

    Roma

  • A.O. Ordine Mauriziano

    Torino

  • A.O.U. OIRM-S. Anna

    Torino

  • ASS N 1 Triestina

    Trieste

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

    Udine

  • Ospedale del Ponte

    Varese

Other trials in Italy

About this study

Official title: A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS

The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.

Read the detailed description

MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as first line treatment (in-label dose and scheduling). This is an exploratory study attempting to identify potential prognostic clinical factors(such as hypertension) and prognostic biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are those expressing the changing nature of the disease in relation to the treatment or simply the tumour progression, these are typically not inherited. Genetic biomarkers are typically inherited and are expression of some characteristics potentially able to interfere with the treatment effect (i.e. Pharmacogenomics).

The safety of this regimen in routine clinical practice will also be described.

Conditions
Ovarian Cancer
Keywords
prognostic factors, biologic factors, clinical factors, routine clinical practice
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    • Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles

  • PaclitaxelDrug

    • Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles

  • CarboplatinDrug

    • Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Study groups in NCT01706120
Study groupRoleWhat they receive
First-line chemotherapy with bevacizumabOther* Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. expression of soluble and tissutal biomarkers

    Measured: measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient

Secondary outcomes (5)

  1. progression free survival

    Measured: one year

  2. overall survival

    Measured: three years

  3. worst grade toxicity per patient

    according to Common Toxicity Criteria for Adverse Events v. 4.03

    Measured: evaluated every 3 weeks up to 15 month

  4. number of patients taking oral antidiabetic therapy

    Measured: at baseline

  5. number of patients taking antithrombotic therapy

    Measured: at baseline

Timeline

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

  1. First posted15 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706120
Sponsor's protocol ID
MITO-16 - MANGO-OV2
Other IDs
2012-003043-29
Acronym
MITO16/MANGO-2
Status last verified
Mar 2023
First submitted
10 Oct 2012
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No

Publications

  • Scaglione GL, Roma C, Califano D, Cecere SC, Lorusso D, Normanno N, Fagotti A, Capoluongo ED, Colombo N, De Luca A, Beltrame L, Pisano C, Russo D, Alberto Lissoni LA, Arenare L, Paracchini L, Ferrero A, De Giorgi U, Musacchio L, Perrone F, Marchini S, Pignata S. Somatic BRCA1 and BRCA2 detection in homologous recombination deficiency testing: concordance of four sequencing workflows with the Myriad myChoice companion diagnostic. Int J Gynecol Cancer. 2026 Jun 20:104823. doi: 10.1016/j.ijgc.2026.104823. Online ahead of print.

    PubMed 42575837

  • Bignotti E, Simeon V, Ardighieri L, Kuhn E, Marchini S, Califano D, Cecere SC, Bugatti M, Spina A, Scognamiglio G, Paracchini L, Russo D, Arenare L, Tognon G, Lorusso D, Beltrame L, D'Incalci M, Sartori E, De Censi A, Odicino F, Perrone F, Chiodini P, Pignata S. TP53 mutations and survival in ovarian carcinoma patients receiving first-line chemotherapy plus bevacizumab: Results of the MITO16A/MaNGO OV-2 study. Int J Cancer. 2025 Mar 1;156(5):1085-1096. doi: 10.1002/ijc.35203. Epub 2024 Oct 16.

    PubMed 39415516

  • Di Liello R, Arenare L, Raspagliesi F, Scambia G, Pisano C, Colombo N, Frezzini S, Tognon G, Artioli G, Gadducci A, Lauria R, Ferrero A, Cinieri S, De Censi A, Breda E, Scollo P, De Giorgi U, Lissoni AA, Katsaros D, Lorusso D, Salutari V, Cecere SC, Lapresa M, Nardin M, Bogani G, Distefano M, Greggi S, Gargiulo P, Schettino C, Gallo C, Daniele G, Califano D, Perrone F, Pignata S, Piccirillo MC. Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO-16A/MaNGO-OV2A trial. Int J Gynecol Cancer. 2021 Oct;31(10):1348-1355. doi: 10.1136/ijgc-2021-002786. Epub 2021 Aug 30.

    PubMed 34462317

  • Daniele G, Raspagliesi F, Scambia G, Pisano C, Colombo N, Frezzini S, Tognon G, Artioli G, Gadducci A, Lauria R, Ferrero A, Cinieri S, De Censi A, Breda E, Scollo P, De Giorgi U, Lissoni AA, Katsaros D, Lorusso D, Salutari V, Cecere SC, Zaccarelli E, Nardin M, Bogani G, Distefano M, Greggi S, Piccirillo MC, Fossati R, Giannone G, Arenare L, Gallo C, Perrone F, Pignata S. Bevacizumab, carboplatin, and paclitaxel in the first line treatment of advanced ovarian cancer patients: the phase IV MITO-16A/MaNGO-OV2A study. Int J Gynecol Cancer. 2021 Jun;31(6):875-882. doi: 10.1136/ijgc-2021-002434. Epub 2021 Apr 30.

    PubMed 33931498

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by National Cancer Institute, Naples at 47 sites in Italy.

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 7 inclusion and 36 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 47 sites in Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

expression of soluble and tissutal biomarkers (time frame: measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient). 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 NCT01706120, 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 24 Mar 2023.

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MITO16/MANGO-2 Clinical Trial NCT01706120 | AzTrials