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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.
First Received: May 15, 2006   Last Updated: November 15, 2007   History of Changes
Sponsor: National Cancer Institute, Naples
Information provided by: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00326456
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Secondary Outcome Measures:
  • overall survival
  • quality of life
  • objective response rate
  • toxicity

Estimated Enrollment: 820
Study Start Date: January 2003
Estimated Study Completion Date: January 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326456

  Hide Study Locations
Locations
Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Azienda Ospedaliera D. Cotugno
Napoli, Italy, 80131
Ospedale S. Giovanni Calibita Gatebenefratelli
Roma, Italy, 00186
Istituto Regina Elena, Divisione di Oncologia Medica
Roma, Italy, 00144
Italy, AV
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, Italy, 83100
Italy, BA
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Bari, BA, Italy, 70126
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
Italy, BG
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
Bergamo, BG, Italy, 24128
Italy, BN
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
Italy, BO
Ospedale Bellari, U.O. di Oncologia
Bologna, BO, Italy, 40139
Ospedale di Bentivoglio
Bentivoglio, BO, Italy, 40010
Ospedale di Budrio
Budrio, BO, Italy, 40054
Italy, CA
Policlinico Universitario, Oncologia Medica II
Cagliari, CA, Italy, 09042
Italy, CB
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
Campobasso, CB, Italy, 86100
Italy, CS
Ospedale Mariano Santo, U.O. di Oncologia Medica
Cosenza, CS, Italy, 87100
Italy, CT
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
Catania, CT, Italy, 95126
Italy, FE
Azienda Ospedaliera Universitaria Acrispedale Sant'Anna
Ferrara, FE, Italy, 44100
Italy, FO
Ospedale Pierantoni, Divisione di Oncologia Medica
Forli', FO, Italy, 47100
Italy, MN
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, Italy, 46100
Italy, MO
Ospedale Ramazzini, Day Hospital Oncologico
Carpi, MO, Italy, 41012
Italy, PA
Policlinico Universitario P. Giaccone
Palermo, PA, Italy, 90100
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy, 90146
Ospedale M. Ascoli
Palermo, PA, Italy, 90127
Italy, PE
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy, 65017
Italy, PN
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
Italy, RA
Ospedale Civile di Faenza, Divisione di Oncologia Medica
Faenza, RA, Italy, 48018
Italy, RE
Azienda Ospedaliera Bianchi Melacrino Morelli Ospedale Riuniti, Divisione di Oncologia Medica
Reggio Calabria, RE, Italy, 89100
Italy, RI
Ospedale degli Infermi, U.O. Oncologia Medica
Rimini, RI, Italy, 47900
Italy, SA
Ospedale Civile Umberto I, Day Hospital Oncoematologico
Nocera Inferiore, SA, Italy, 84014
Italy, TN
Ospedale S. Chiara, U.O. di Oncologia Medica
Trento, TN, Italy, 38100
Italy, to
Ospedale S. Anna, Day Hospital Oncologico Divisione A
Torino, to, Italy, 10126
Italy, VI
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy, 36100
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:
Study ID Numbers: MITO-2, EudraCT number 2005-004453-98
Study First Received: May 15, 2006
Last Updated: November 15, 2007
ClinicalTrials.gov Identifier: NCT00326456     History of Changes
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 22, 2009