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

Primary Purpose

Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
liposomal doxorubicin
carboplatin
paclitaxel
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, chemotherapy, first-line

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica Malzoni, Reparto di Ginecologia Oncologica
  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
  • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
  • IRCCS Oncologico Bari, Oncologia Medica
  • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
  • Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
  • Ospedale Fatebenefratelli, U.O. di Oncologia
  • Ospedale di Bentivoglio
  • Ospedale Bellari, U.O. di Oncologia
  • Ospedale di Budrio
  • Policlinico Universitario, Oncologia Medica II
  • Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
  • Ospedale Mariano Santo, U.O. di Oncologia Medica
  • Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
  • Azienda Ospedaliera Universitaria Acrispedale Sant'Anna
  • Ospedale Pierantoni, Divisione di Oncologia Medica
  • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
  • Ospedale Ramazzini, Day Hospital Oncologico
  • Policlinico Universitario P. Giaccone
  • Ospedale M. Ascoli
  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
  • Ospedale S. Massimo, Day Hospital Oncologico
  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
  • Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
  • Ospedale Civile di Faenza, Divisione di Oncologia Medica
  • Azienda Ospedaliera Bianchi Melacrino Morelli Ospedale Riuniti, Divisione di Oncologia Medica
  • Ospedale degli Infermi, U.O. Oncologia Medica
  • Ospedale Civile Umberto I, Day Hospital Oncoematologico
  • Ospedale S. Chiara, U.O. di Oncologia Medica
  • Ospedale S. Anna, Day Hospital Oncologico Divisione A
  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
  • Azienda Ospedaliera D. Cotugno
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
  • Istituto Regina Elena, Divisione di Oncologia Medica
  • Ospedale S. Giovanni Calibita Gatebenefratelli
  • CHC Maternidade Bissaya-Barreto, Gynecology Unit
  • Istanbul University Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

carboplatin and liposomal doxorubicin

carboplatin and paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

overall survival
quality of life
objective response rate
adverse events
according to CTCAE criteria

Full Information

First Posted
May 15, 2006
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00326456
Brief Title
MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
Official Title
Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2003 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, chemotherapy, first-line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
820 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carboplatin and liposomal doxorubicin
Arm Type
Experimental
Arm Title
carboplatin and paclitaxel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin
Intervention Description
30 mg/m2 gieven intravenously on day 1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 5 intravenously on day 1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
175 mg/m2 intravenously on day 1 every 3 weeks
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
at 2 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
4 years
Title
quality of life
Time Frame
at baseline and every 3 weeks during treatment
Title
objective response rate
Time Frame
at 9 and 18 weeks after starting study therapy
Title
adverse events
Description
according to CTCAE criteria
Time Frame
every 3 weeks during chemotherapy

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Pignata, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Malzoni, Reparto di Ginecologia Oncologica
City
Avellino
State/Province
AV
ZIP/Postal Code
83100
Country
Italy
Facility Name
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
City
Monteforte Irpino
State/Province
AV
ZIP/Postal Code
83024
Country
Italy
Facility Name
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
City
Acquaviva delle Fonti
State/Province
BA
ZIP/Postal Code
70021
Country
Italy
Facility Name
IRCCS Oncologico Bari, Oncologia Medica
City
Bari
State/Province
BA
ZIP/Postal Code
70126
Country
Italy
Facility Name
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
City
Bari
State/Province
BA
ZIP/Postal Code
70126
Country
Italy
Facility Name
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
City
Bergamo
State/Province
BG
ZIP/Postal Code
24128
Country
Italy
Facility Name
Ospedale Fatebenefratelli, U.O. di Oncologia
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Ospedale di Bentivoglio
City
Bentivoglio
State/Province
BO
ZIP/Postal Code
40010
Country
Italy
Facility Name
Ospedale Bellari, U.O. di Oncologia
City
Bologna
State/Province
BO
ZIP/Postal Code
40139
Country
Italy
Facility Name
Ospedale di Budrio
City
Budrio
State/Province
BO
ZIP/Postal Code
40054
Country
Italy
Facility Name
Policlinico Universitario, Oncologia Medica II
City
Cagliari
State/Province
CA
ZIP/Postal Code
09042
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
City
Campobasso
State/Province
CB
ZIP/Postal Code
86100
Country
Italy
Facility Name
Ospedale Mariano Santo, U.O. di Oncologia Medica
City
Cosenza
State/Province
CS
ZIP/Postal Code
87100
Country
Italy
Facility Name
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
City
Catania
State/Province
CT
ZIP/Postal Code
95126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Acrispedale Sant'Anna
City
Ferrara
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Ospedale Pierantoni, Divisione di Oncologia Medica
City
Forli'
State/Province
FO
ZIP/Postal Code
47100
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
City
Mantova
State/Province
MN
ZIP/Postal Code
46100
Country
Italy
Facility Name
Ospedale Ramazzini, Day Hospital Oncologico
City
Carpi
State/Province
MO
ZIP/Postal Code
41012
Country
Italy
Facility Name
Policlinico Universitario P. Giaccone
City
Palermo
State/Province
PA
ZIP/Postal Code
90100
Country
Italy
Facility Name
Ospedale M. Ascoli
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Ospedale S. Massimo, Day Hospital Oncologico
City
Penne
State/Province
PE
ZIP/Postal Code
65017
Country
Italy
Facility Name
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
City
Pordenone
State/Province
PN
ZIP/Postal Code
33170
Country
Italy
Facility Name
Ospedale Civile di Faenza, Divisione di Oncologia Medica
City
Faenza
State/Province
RA
ZIP/Postal Code
48018
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi Melacrino Morelli Ospedale Riuniti, Divisione di Oncologia Medica
City
Reggio Calabria
State/Province
RE
ZIP/Postal Code
89100
Country
Italy
Facility Name
Ospedale degli Infermi, U.O. Oncologia Medica
City
Rimini
State/Province
RI
ZIP/Postal Code
47900
Country
Italy
Facility Name
Ospedale Civile Umberto I, Day Hospital Oncoematologico
City
Nocera Inferiore
State/Province
SA
ZIP/Postal Code
84014
Country
Italy
Facility Name
Ospedale S. Chiara, U.O. di Oncologia Medica
City
Trento
State/Province
TN
ZIP/Postal Code
38100
Country
Italy
Facility Name
Ospedale S. Anna, Day Hospital Oncologico Divisione A
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
City
Vicenza
State/Province
VI
ZIP/Postal Code
36100
Country
Italy
Facility Name
Azienda Ospedaliera D. Cotugno
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Regina Elena, Divisione di Oncologia Medica
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Gatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy
Facility Name
CHC Maternidade Bissaya-Barreto, Gynecology Unit
City
Coimbra
ZIP/Postal Code
3000
Country
Portugal
Facility Name
Istanbul University Medical Oncology
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16882344
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.
Results Reference
background
PubMed Identifier
19039248
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.
Results Reference
background
PubMed Identifier
21844495
Citation
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.
Results Reference
result

Learn more about this trial

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

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