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Ovarian CancerPhase 3MITO-8NCT00657878

Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

A Phase 3 study testing stealth liposomal doxorubicin, carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 40 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
stealth 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
215 participants
Where
40 sitesin 3 countries
Study dates
Nov 2008to 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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of ovarian cancer
  • Disease recurrence between 6 and 12 months after a first-line platinum based therapy
  • Indication for chemotherapy, but no more than 2 previous lines of previous therapy
  • Life expectancy of more than 3 months

Who cannot join

  • Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix)
  • ECOG Performance Status at least 3
  • Previous treatment with stealth liposomal doxorubicin
  • Residual peripheral neuropathy Grade 3 or higher
  • Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
  • Neutrophils < 2000 x mm3, platelets < 100000 x mm3
Show all 11Show fewer
  • Inadequate renal function (creatinine no greater than 1.25 x normal values) or liver function (ALT or AST no greater than 1.25 x normal values)
  • Present or suspected hemorrhagic syndromes
  • Inability to comply with protocol and follow-up
  • Inability to access study site for clinical visits
  • Refusal of informed consent

Trial locations and contacts

40 sites in 3 countries.

40 sites in 3 countries

Italy27 sites

  • Ospedale Mazzoni

    Ascoli Piceno

  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C

    Aviano, PN, 33081

  • Policlinico Universitario

    Bari

  • Universita di Bari Policinico I Clinical Ostetrica e Ginecologica

    Bari

  • Ospedale Fatebenefratelli

    Benevento

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • Universita Cattolica del Sacro Cuore

    Campobasso

  • Ospedale Renzetti di Lanciano

    Lanciano

  • Ospedale A. Manzoni

    Lecco

  • Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • Istituto Europeo di Oncologia

    Milan

  • Ospedale San Raffaele

    Milan

  • Ospedale S. Gerardo

    Monza

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

    Naples, 80131

  • Azienda Ospedaliera V. Cervello

    Palermo, PA

  • Ospedale S. Massimo, Day Hospital Oncologico

    Penne, PE, 65017

  • Ospedale Silvestrini

    Perugia

  • Ospedale Civile S. Spirito

    Pescara

  • A.O. Bianchi Melacrino Morelli Ospedale Riuniti

    Reggio Calabria

  • Arcispedale S. Maria Nuova

    Reggio Emilia

  • Ospedale degli Infermi, U.O. Oncologia Medica

    Rimini

  • Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia

    Roma

  • Universita Cattolica del Sacro Cuore

    Roma

  • A.O. Ordine Mauriziano

    Torino

  • Ospedale S. Chiara

    Trento

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

    Udine

  • Ospedale Del Ponte

    Varese

Other trials in Italy

Germany8 sites

  • Charité Campus Virchow-Klinkum

    Berlin

  • Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft

    Essen

  • Universitatsklinikum

    Essen

  • Universitatsklinikum

    Freiburg im Breisgau

  • Gynecology, Albertinen Krankenhaus

    Hamburg

  • Universitatskilinikum Schleswig-Holstein

    Kiel

  • Frauenklinik

    Marburg

  • Klinikum rechts der Isar der Technischen Universitat

    München

Other trials in Germany

Belgium5 sites

  • AZ Groeninge

    Kortrijk

  • UZ Gasthusiberg

    Leuven

  • CHC-Clinique St-Joseph

    Liège

  • Clinique & Maternité Sainte-Elisabeth

    Namur

  • AZ Nikolaas

    Sint-Niklaas

Other trials in Belgium

About this study

Official title: Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

Read the detailed description

Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen.

Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients.

This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.

Conditions
Ovarian Cancer
Being tested
stealth liposomal doxorubicin, carboplatin, paclitaxel, Topotecan, Gemcitabine
Keywords
platinum free interval, chemotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • stealth liposomal doxorubicinDrug

    stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days

  • carboplatinDrug

    carboplatin AUC 5 IV day 1 every 21 days

  • paclitaxelDrug

    paclitaxel 175 mg/m2 IV day 1 every 21 days

  • TopotecanDrug

    dosing and schedule according to Institutional guidelines

  • GemcitabineDrug

    1000 mg/m2 on days 1,8,15 every 28 days

Study groups in NCT00657878
Study groupRoleWhat they receive
non platinum based chemotherapyExperimentala non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression
Receives: Drug: stealth liposomal doxorubicin; Drug: carboplatin; Drug: paclitaxel; Drug: Topotecan; Drug: Gemcitabine
platinum based chemotherapyActive comparatorplatinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression
Receives: Drug: stealth liposomal doxorubicin; Drug: carboplatin; Drug: paclitaxel; Drug: Topotecan; Drug: Gemcitabine

What is being measured

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

  1. overall survival

    Measured: 18 months

Secondary outcomes (4)

  1. progression free survival

    Measured: 18 months

  2. changes in quality of life

    quality of life is measured at baseline and at 3 months and 6 months after patient begins study

    Measured: 9 months

  3. number of objective responses

    Measured: 6 months

  4. worst grade toxicity for each patient

    Measured: 6 months

Timeline

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

  1. First posted14 Apr 2008 (estimated)
  2. Study startNov 2008
  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
Crossover
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00657878
Sponsor's protocol ID
MITO-8
Other IDs
2008-001755-22, 2008
Acronym
MITO-8
Status last verified
Mar 2023
First submitted
8 Apr 2008
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • Piccirillo MC, Scambia G, Bologna A, Signoriello S, Vergote I, Baumann K, Lorusso D, Murgia V, Sorio R, Ferrandina G, Sacco C, Cormio G, Breda E, Cinieri S, Natale D, Mangili G, Pisano C, Cecere SC, Di Napoli M, Salutari V, Raspagliesi F, Arenare L, Bergamini A, Bryce J, Daniele G, Gallo C, Pignata S, Perrone F. Quality-of-life analysis of the MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study comparing platinum-based versus non-platinum-based chemotherapy in patients with partially platinum-sensitive recurrent ovarian cancer. Ann Oncol. 2018 May 1;29(5):1189-1194. doi: 10.1093/annonc/mdy062.

    PubMed 29462248

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing stealth liposomal doxorubicin, carboplatin and paclitaxel in people with Ovarian Cancer, run by National Cancer Institute, Naples at 40 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 11 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Italy, Germany, Belgium. 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?

overall survival (time frame: 18 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 NCT00657878, which also lists 1 linked publication.

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 13 Nov 2023.

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