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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00326456
• Other study ID #: MITO-2
• Secondary ID: 2005-004453-98
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 1, 2003
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 820
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica	Acquaviva delle Fonti	BA
Italy	Clinica Malzoni, Reparto di Ginecologia Oncologica	Avellino	AV
Italy	Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C	Aviano	PN
Italy	IRCCS Oncologico Bari, Oncologia Medica	Bari	BA
Italy	Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale	Bari	BA
Italy	Ospedale Fatebenefratelli, U.O. di Oncologia	Benevento	BN
Italy	Ospedale di Bentivoglio	Bentivoglio	BO
Italy	Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia	Bergamo	BG
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 Ramazzini, Day Hospital Oncologico	Carpi	MO
Italy	Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia	Catania	CT
Italy	Ospedale Mariano Santo, U.O. di Oncologia Medica	Cosenza	CS
Italy	Ospedale Civile di Faenza, Divisione di Oncologia Medica	Faenza	RA
Italy	Azienda Ospedaliera Universitaria Acrispedale Sant'Anna	Ferrara	FE
Italy	Ospedale Pierantoni, Divisione di Oncologia Medica	Forli'	FO
Italy	Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia	Mantova	MN
Italy	Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica	Monteforte Irpino	AV
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	Ospedale Civile Umberto I, Day Hospital Oncoematologico	Nocera Inferiore	SA
Italy	Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico	Palermo	PA
Italy	Ospedale M. Ascoli	Palermo	PA
Italy	Policlinico Universitario P. Giaccone	Palermo	PA
Italy	Ospedale S. Massimo, Day Hospital Oncologico	Penne	PE
Italy	Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia	Pordenone	PN
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	Istituto Regina Elena, Divisione di Oncologia Medica	Roma
Italy	Ospedale S. Giovanni Calibita Gatebenefratelli	Roma
Italy	Ospedale S. Anna, Day Hospital Oncologico Divisione A	Torino	TO
Italy	Ospedale S. Chiara, U.O. di Oncologia Medica	Trento	TN
Italy	Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica	Vicenza	VI
Portugal	CHC Maternidade Bissaya-Barreto, Gynecology Unit	Coimbra
Turkey	Istanbul University Medical Oncology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Countries where clinical trial is conducted

Italy,  Portugal,  Turkey, 

References & Publications (3)

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, L — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		at 2 years
Secondary	overall survival		4 years
Secondary	quality of life		at baseline and every 3 weeks during treatment
Secondary	objective response rate		at 9 and 18 weeks after starting study therapy
Secondary	adverse events	according to CTCAE criteria	every 3 weeks during chemotherapy