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

NCT00326456 | Unknown Phase 3 DMC

• 2 other identifiers: MITO-22005-004453-98
• Study Type: interventional
• Target: 820
• Locations: 3 countries
• Sites: 38

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

Conditions

Ovarian Cancer

Keywords

ovarian cancer; chemotherapy; first-line

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  at 2 years

Secondary Outcomes (4)

• overall survival

  4 years

• quality of life

  at baseline and every 3 weeks during treatment

• objective response rate

  at 9 and 18 weeks after starting study therapy

• adverse events

  every 3 weeks during chemotherapy

Study Arms (2)

carboplatin and liposomal doxorubicin

EXPERIMENTAL

Drug: liposomal doxorubicin; Drug: carboplatin

carboplatin and paclitaxel

ACTIVE COMPARATOR

Drug: carboplatin; Drug: paclitaxel

Interventions

liposomal doxorubicin DRUG

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

carboplatin and liposomal doxorubicin

carboplatin DRUG

AUC 5 intravenously on day 1 every 3 weeks

carboplatin and liposomal doxorubicin; carboplatin and paclitaxel

paclitaxel DRUG

175 mg/m2 intravenously on day 1 every 3 weeks

carboplatin and paclitaxel

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (38)

Clinica Malzoni, Reparto di Ginecologia Oncologica

Avellino, AV, 83100, Italy

Location

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

Monteforte Irpino, AV, 83024, Italy

Location

Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica

Acquaviva delle Fonti, BA, 70021, Italy

Location

IRCCS Oncologico Bari, Oncologia Medica

Bari, BA, 70126, Italy

Location

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

Bari, BA, 70126, Italy

Location

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

Bergamo, BG, 24128, Italy

Location

Ospedale Fatebenefratelli, U.O. di Oncologia

Benevento, BN, 82100, Italy

Location

Ospedale di Bentivoglio

Bentivoglio, BO, 40010, Italy

Location

Ospedale Bellari, U.O. di Oncologia

Bologna, BO, 40139, Italy

Location

Ospedale di Budrio

Budrio, BO, 40054, Italy

Location

Policlinico Universitario, Oncologia Medica II

Cagliari, CA, 09042, Italy

Location

Università Cattolica del Sacro Cuore, Dipartimento di Oncologia

Campobasso, CB, 86100, Italy

Location

Ospedale Mariano Santo, U.O. di Oncologia Medica

Cosenza, CS, 87100, Italy

Location

Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia

Catania, CT, 95126, Italy

Location

Azienda Ospedaliera Universitaria Acrispedale Sant'Anna

Ferrara, FE, 44100, Italy

Location

Ospedale Pierantoni, Divisione di Oncologia Medica

Forlì, FO, 47100, Italy

Location

Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia

Mantova, MN, 46100, Italy

Location

Ospedale Ramazzini, Day Hospital Oncologico

Carpi, MO, 41012, Italy

Location

Policlinico Universitario P. Giaccone

Palermo, PA, 90100, Italy

Location

Ospedale M. Ascoli

Palermo, PA, 90127, Italy

Location

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

Palermo, PA, 90146, Italy

Location

Ospedale S. Massimo, Day Hospital Oncologico

Penne, PE, 65017, Italy

Location

Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C

Aviano, PN, 33081, Italy

Location

Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia

Pordenone, PN, 33170, Italy

Location

Ospedale Civile di Faenza, Divisione di Oncologia Medica

Faenza, RA, 48018, Italy

Location

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

Reggio Calabria, RE, 89100, Italy

Location

Ospedale degli Infermi, U.O. Oncologia Medica

Rimini, RI, 47900, Italy

Location

Ospedale Civile Umberto I, Day Hospital Oncoematologico

Nocera Inferiore, SA, 84014, Italy

Location

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

Trento, TN, 38100, Italy

Location

Ospedale S. Anna, Day Hospital Oncologico Divisione A

Torino, TO, 10126, Italy

Location

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

Vicenza, VI, 36100, Italy

Location

Azienda Ospedaliera D. Cotugno

Napoli, 80131, Italy

Location

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, 80131, Italy

Location

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, 80131, Italy

Location

Istituto Regina Elena, Divisione di Oncologia Medica

Roma, 00144, Italy

Location

Ospedale S. Giovanni Calibita Gatebenefratelli

Roma, 00186, Italy

Location

CHC Maternidade Bissaya-Barreto, Gynecology Unit

Coimbra, 3000, Portugal

Location

Istanbul University Medical Oncology

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 16882344 BACKGROUND

• 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.

  PMID: 19039248 BACKGROUND

• 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.

  PMID: 21844495 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicin; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Sandro Pignata, M.D., Ph.D

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2006
• First Posted: May 16, 2006
• Study Start: January 1, 2003
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

TU (1); PT (1); IT (36)