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

March 23, 2023 updated by: National Cancer Institute, Naples

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

820

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
      • Napoli, Italy, 80131
        • Azienda Ospedaliera D. Cotugno
      • Roma, Italy, 00144
        • Istituto Regina Elena, Divisione di Oncologia Medica
      • Roma, Italy, 00186
        • Ospedale S. Giovanni Calibita Gatebenefratelli
    • AV
      • Avellino, AV, Italy, 83100
        • Clinica Malzoni, Reparto di Ginecologia Oncologica
      • Monteforte Irpino, AV, Italy, 83024
        • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
    • BA
      • Acquaviva delle Fonti, BA, Italy, 70021
        • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
      • Bari, BA, Italy, 70126
        • IRCCS Oncologico Bari, Oncologia Medica
      • Bari, BA, Italy, 70126
        • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
    • BG
      • Bergamo, BG, Italy, 24128
        • Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
    • BN
      • Benevento, BN, Italy, 82100
        • Ospedale Fatebenefratelli, U.O. di Oncologia
    • BO
      • Bentivoglio, BO, Italy, 40010
        • Ospedale di Bentivoglio
      • Bologna, BO, Italy, 40139
        • Ospedale Bellari, U.O. di Oncologia
      • Budrio, BO, Italy, 40054
        • Ospedale di Budrio
    • CA
      • Cagliari, CA, Italy, 09042
        • Policlinico Universitario, Oncologia Medica II
    • CB
      • Campobasso, CB, Italy, 86100
        • Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
    • CS
      • Cosenza, CS, Italy, 87100
        • Ospedale Mariano Santo, U.O. di Oncologia Medica
    • CT
      • Catania, CT, Italy, 95126
        • Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
    • FE
      • Ferrara, FE, Italy, 44100
        • Azienda Ospedaliera Universitaria Acrispedale Sant'Anna
    • FO
      • Forli', FO, Italy, 47100
        • Ospedale Pierantoni, Divisione di Oncologia Medica
    • MN
      • Mantova, MN, Italy, 46100
        • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
    • MO
      • Carpi, MO, Italy, 41012
        • Ospedale Ramazzini, Day Hospital Oncologico
    • PA
      • Palermo, PA, Italy, 90100
        • Policlinico Universitario P. Giaccone
      • Palermo, PA, Italy, 90146
        • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
      • Palermo, PA, Italy, 90127
        • Ospedale M. Ascoli
    • PE
      • Penne, PE, Italy, 65017
        • Ospedale S. Massimo, Day Hospital Oncologico
    • PN
      • Aviano, PN, Italy, 33081
        • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
      • Pordenone, PN, Italy, 33170
        • Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
    • RA
      • Faenza, RA, Italy, 48018
        • Ospedale Civile di Faenza, Divisione di Oncologia Medica
    • RE
      • Reggio Calabria, RE, Italy, 89100
        • Azienda Ospedaliera Bianchi Melacrino Morelli Ospedale Riuniti, Divisione di Oncologia Medica
    • RI
      • Rimini, RI, Italy, 47900
        • Ospedale degli Infermi, U.O. Oncologia Medica
    • SA
      • Nocera Inferiore, SA, Italy, 84014
        • Ospedale Civile Umberto I, Day Hospital Oncoematologico
    • TN
      • Trento, TN, Italy, 38100
        • Ospedale S. Chiara, U.O. di Oncologia Medica
    • TO
      • Torino, TO, Italy, 10126
        • Ospedale S. Anna, Day Hospital Oncologico Divisione A
    • VI
      • Vicenza, VI, Italy, 36100
        • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
  • Portugal
      • Coimbra, Portugal, 3000
        • CHC Maternidade Bissaya-Barreto, Gynecology Unit
  • Turkey
      • Istanbul, Turkey
        • Istanbul University Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Present or suspected hemorrhagic syndromes
  • Uncooperative and/or unreliable patients
  • Patient's inability to access the center
  • Refusal of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carboplatin and liposomal doxorubicin
Drug: liposomal doxorubicin
30 mg/m2 gieven intravenously on day 1 every 3 weeks
Drug: carboplatin
AUC 5 intravenously on day 1 every 3 weeks
Active Comparator: carboplatin and paclitaxel
Drug: carboplatin
AUC 5 intravenously on day 1 every 3 weeks
Drug: paclitaxel
175 mg/m2 intravenously on day 1 every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: at 2 years
at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 4 years
4 years
quality of life
Time Frame: at baseline and every 3 weeks during treatment
at baseline and every 3 weeks during treatment
objective response rate
Time Frame: at 9 and 18 weeks after starting study therapy
at 9 and 18 weeks after starting study therapy
adverse events
Time Frame: every 3 weeks during chemotherapy
according to CTCAE criteria
every 3 weeks during chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Francesco Perrone, M.D., Ph.D, National Cancer Institute, Naples
  • Principal Investigator: Sandro Pignata, M.D., Ph.D, National Cancer Institute, Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2003

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITO-2
  • 2005-004453-98 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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