MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
NCT ID: NCT00326456
Last Updated: 2023-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
820 participants
INTERVENTIONAL
2003-01-01
2023-12-31
Brief Summary
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Secondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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carboplatin and liposomal doxorubicin
liposomal doxorubicin
30 mg/m2 gieven intravenously on day 1 every 3 weeks
carboplatin
AUC 5 intravenously on day 1 every 3 weeks
carboplatin and paclitaxel
carboplatin
AUC 5 intravenously on day 1 every 3 weeks
paclitaxel
175 mg/m2 intravenously on day 1 every 3 weeks
Interventions
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liposomal doxorubicin
30 mg/m2 gieven intravenously on day 1 every 3 weeks
carboplatin
AUC 5 intravenously on day 1 every 3 weeks
paclitaxel
175 mg/m2 intravenously on day 1 every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Indication for chemotherapy treatment
* Age 75 years or less
* Life expectancy of at least 3 months
Exclusion Criteria
* 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
75 Years
FEMALE
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Sandro Pignata, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Locations
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Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Bari, BA, Italy
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
Bergamo, BG, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy
Ospedale di Bentivoglio
Bentivoglio, BO, Italy
Ospedale Bellari, U.O. di Oncologia
Bologna, BO, Italy
Ospedale di Budrio
Budrio, BO, Italy
Policlinico Universitario, Oncologia Medica II
Cagliari, CA, Italy
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
Campobasso, CB, Italy
Ospedale Mariano Santo, U.O. di Oncologia Medica
Cosenza, CS, Italy
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
Catania, CT, Italy
Azienda Ospedaliera Universitaria Acrispedale Sant'Anna
Ferrara, FE, Italy
Ospedale Pierantoni, Divisione di Oncologia Medica
Forlì, FO, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, Italy
Ospedale Ramazzini, Day Hospital Oncologico
Carpi, MO, Italy
Policlinico Universitario P. Giaccone
Palermo, PA, Italy
Ospedale M. Ascoli
Palermo, PA, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Aviano, PN, Italy
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
Pordenone, PN, Italy
Ospedale Civile di Faenza, Divisione di Oncologia Medica
Faenza, RA, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli Ospedale Riuniti, Divisione di Oncologia Medica
Reggio Calabria, RE, Italy
Ospedale degli Infermi, U.O. Oncologia Medica
Rimini, RI, Italy
Ospedale Civile Umberto I, Day Hospital Oncoematologico
Nocera Inferiore, SA, Italy
Ospedale S. Chiara, U.O. di Oncologia Medica
Trento, TN, Italy
Ospedale S. Anna, Day Hospital Oncologico Divisione A
Torino, TO, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy
Azienda Ospedaliera D. Cotugno
Napoli, , Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, , Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, , Italy
Istituto Regina Elena, Divisione di Oncologia Medica
Roma, , Italy
Ospedale S. Giovanni Calibita Gatebenefratelli
Roma, , Italy
CHC Maternidade Bissaya-Barreto, Gynecology Unit
Coimbra, , Portugal
Istanbul University Medical Oncology
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
Other Identifiers
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2005-004453-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MITO-2
Identifier Type: -
Identifier Source: org_study_id
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