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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00326456
First received: May 15, 2006
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: liposomal doxorubicin
Drug: carboplatin
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at baseline and every 3 weeks during treatment ] [ Designated as safety issue: No ]
  • objective response rate [ Time Frame: at 9 and 18 weeks after starting study therapy ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: every 3 weeks during chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 820
Study Start Date: January 2003
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326456

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

Publications:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00326456     History of Changes
Other Study ID Numbers: MITO-2, 2005-004453-98
Study First Received: May 15, 2006
Last Updated: July 29, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
ovarian cancer
chemotherapy
first-line

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Liposomal doxorubicin
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014