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Ovarian CancerPhase 3NCT00326456

MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer

A Phase 3 study testing liposomal doxorubicin, carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 38 sites in 3 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The purpose of this study is to compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer. Read more about this study

Who is it for?
Ages Up to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
liposomal doxorubicin, carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
820 participants
Where
38 sitesin 3 countries
Study dates
1 Jan 2003to 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 Up to 75 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Cytologic / histologic diagnosis of stage Ic-IV ovarian cancer
  • Indication for chemotherapy treatment
  • Age 75 years or less
  • Life expectancy of at least 3 months

Who cannot join

  • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
  • Performance status (ECOG) > 2
  • Previous chemotherapy treatment
  • Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)
  • Leukocytes < 4000/mm3, neutrophils < 2000/mm3, platelets < 100000/mm3
  • Impaired renal function (creatinine > 1.25 times the upper normal limit) or liver function (SGOT or SGPT > 1.25 times the upper normal limit)
Show all 10Show fewer
  • Present or suspected hemorrhagic syndromes
  • Uncooperative and/or unreliable patients
  • Patient's inability to access the center
  • Refusal of informed consent

Trial locations and contacts

38 sites in 3 countries.

38 sites in 3 countries

Italy36 sites

  • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica

    Acquaviva delle Fonti, BA, 70021

  • Clinica Malzoni, Reparto di Ginecologia Oncologica

    Avellino, AV, 83100

  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C

    Aviano, PN, 33081

  • IRCCS Oncologico Bari, Oncologia Medica

    Bari, BA, 70126

  • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale

    Bari, BA, 70126

  • Ospedale Fatebenefratelli, U.O. di Oncologia

    Benevento, BN, 82100

  • Ospedale di Bentivoglio

    Bentivoglio, BO, 40010

  • Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia

    Bergamo, BG, 24128

  • Ospedale Bellari, U.O. di Oncologia

    Bologna, BO, 40139

  • Ospedale di Budrio

    Budrio, BO, 40054

  • Policlinico Universitario, Oncologia Medica II

    Cagliari, CA, 09042

  • Università Cattolica del Sacro Cuore, Dipartimento di Oncologia

    Campobasso, CB, 86100

  • Ospedale Ramazzini, Day Hospital Oncologico

    Carpi, MO, 41012

  • Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia

    Catania, CT, 95126

  • Ospedale Mariano Santo, U.O. di Oncologia Medica

    Cosenza, CS, 87100

  • Ospedale Civile di Faenza, Divisione di Oncologia Medica

    Faenza, RA, 48018

  • Azienda Ospedaliera Universitaria Acrispedale Sant'Anna

    Ferrara, FE, 44100

  • Ospedale Pierantoni, Divisione di Oncologia Medica

    Forlì, FO, 47100

  • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia

    Mantua, MN, 46100

  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

    Monteforte Irpino, AV, 83024

  • Azienda Ospedaliera D. Cotugno

    Naples, 80131

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

    Naples, 80131

  • Ospedale Civile Umberto I, Day Hospital Oncoematologico

    Nocera Inferiore, SA, 84014

  • Policlinico Universitario P. Giaccone

    Palermo, PA, 90100

  • Ospedale M. Ascoli

    Palermo, PA, 90127

  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico

    Palermo, PA, 90146

  • Ospedale S. Massimo, Day Hospital Oncologico

    Penne, PE, 65017

  • Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia

    Pordenone, PN, 33170

  • Azienda Ospedaliera Bianchi Melacrino Morelli Ospedale Riuniti, Divisione di Oncologia Medica

    Reggio Calabria, RE, 89100

  • Ospedale degli Infermi, U.O. Oncologia Medica

    Rimini, RI, 47900

  • Istituto Regina Elena, Divisione di Oncologia Medica

    Roma, 00144

  • Ospedale S. Giovanni Calibita Gatebenefratelli

    Roma, 00186

  • Ospedale S. Anna, Day Hospital Oncologico Divisione A

    Torino, TO, 10126

  • Ospedale S. Chiara, U.O. di Oncologia Medica

    Trento, TN, 38100

  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

    Vicenza, VI, 36100

Other trials in Italy

Portugal1 site

  • CHC Maternidade Bissaya-Barreto, Gynecology Unit

    Coimbra, 3000

Other trials in Portugal

Turkey (Türkiye)1 site

  • Istanbul University Medical Oncology

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer

The purpose of this study is to compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer.

Secondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.

Read the detailed description

Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. The high mortality rate is due to the late diagnosis of this malignancy that often develops without symptoms, as well as to limited results in treatment of the disease. Patients may respond well initially to chemotherapy, but the vast majority of patients will experience a progression of the disease. The poor long term results in the standard treatment available today for first-line chemotherapy of ovarian cancer make research into new, more beneficial treatment strategies necessary. The proven efficacy of liposomal doxorubicin in second line treatment, where it is the first drug to have shown some significant benefit in terms of survival, and the possibility of easily combining it with full doses and normal use of carboplatin, encourages the testing of the effectiveness of the combination of carboplatin and liposomal doxorubicin in first line treatment.

Patients enrolled into this study will be randomly assigned to one of two treatment groups:

  • Standard therapy consisting of 6 cycles of chemotherapy:
  • carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND
  • paclitaxel 175 mg/m2 given intravenously on day 1 every 3 weeks

OR

  • Experimental therapy consisting of 6 cycles of chemotherapy:
  • carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND
  • liposomal doxorubicin 30 mg/m2 given intravenously on day 1 every 3 weeks
Conditions
Ovarian Cancer
Being tested
liposomal doxorubicin, carboplatin, paclitaxel
Keywords
ovarian cancer, chemotherapy, first-line
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • liposomal doxorubicinDrug

    30 mg/m2 gieven intravenously on day 1 every 3 weeks

  • carboplatinDrug

    AUC 5 intravenously on day 1 every 3 weeks

  • paclitaxelDrug

    175 mg/m2 intravenously on day 1 every 3 weeks

Study groups in NCT00326456
Study groupRoleWhat they receive
carboplatin and liposomal doxorubicinExperimentalNot described
Receives: Drug: liposomal doxorubicin; Drug: carboplatin
carboplatin and paclitaxelActive comparatorNot described
Receives: Drug: carboplatin; Drug: paclitaxel

What is being measured

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

  1. Progression free survival

    Measured: at 2 years

Secondary outcomes (4)

  1. overall survival

    Measured: 4 years

  2. quality of life

    Measured: at baseline and every 3 weeks during treatment

  3. objective response rate

    Measured: at 9 and 18 weeks after starting study therapy

  4. adverse events

    according to CTCAE criteria

    Measured: every 3 weeks during chemotherapy

Timeline

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

  1. First posted16 May 2006 (estimated)
  2. Study start1 Jan 2003
  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
820 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00326456
Sponsor's protocol ID
MITO-2
Other IDs
2005-004453-98, 2005
Status last verified
Mar 2023
First submitted
15 May 2006
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Pignata S, Scambia G, Savarese A, Breda E, Scollo P, De Vivo R, Rossi E, Gebbia V, Natale D, Del Gaizo F, Naglieri E, Ferro A, Musso P, D'Arco AM, Sorio R, Pisano C, Di Maio M, Signoriello G, Annunziata A, Perrone F; MITO Investigators. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial. BMC Cancer. 2006 Aug 1;6:202. doi: 10.1186/1471-2407-6-202.

    PubMed 16882344

  • Pignata S, Scambia G, Savarese A, Breda E, Sorio R, Pisano C, Lorusso D, Cognetti F, Vernaglia Lombardi A, Gebbia V, Scollo P, Morabito A, Signoriello G, Perrone F. Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer: preliminary activity results of the MITO-2 phase III trial. Oncology. 2009;76(1):49-54. doi: 10.1159/000178760. Epub 2008 Nov 27.

    PubMed 19039248

  • Pignata S, Scambia G, Ferrandina G, Savarese A, Sorio R, Breda E, Gebbia V, Musso P, Frigerio L, Del Medico P, Lombardi AV, Febbraro A, Scollo P, Ferro A, Tamberi S, Brandes A, Ravaioli A, Valerio MR, Aitini E, Natale D, Scaltriti L, Greggi S, Pisano C, Lorusso D, Salutari V, Legge F, Di Maio M, Morabito A, Gallo C, Perrone F. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. J Clin Oncol. 2011 Sep 20;29(27):3628-35. doi: 10.1200/JCO.2010.33.8566. Epub 2011 Aug 15.

    PubMed 21844495

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liposomal doxorubicin, carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 38 sites in 3 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 4 inclusion and 10 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 27 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 38 sites in Italy, Portugal, Turkey (Türkiye). 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: at 2 years). 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 NCT00326456, 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 27 Mar 2023.

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