Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00326456
Status:
UNKNOWN
Last Update Posted:
2023-03-27
First Post:
2006-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 820}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2006-05-15', 'studyFirstSubmitQcDate': '2006-05-15', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'at 2 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '4 years'}, {'measure': 'quality of life', 'timeFrame': 'at baseline and every 3 weeks during treatment'}, {'measure': 'objective response rate', 'timeFrame': 'at 9 and 18 weeks after starting study therapy'}, {'measure': 'adverse events', 'timeFrame': 'every 3 weeks during chemotherapy', 'description': 'according to CTCAE criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ovarian cancer', 'chemotherapy', 'first-line'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '16882344', 'type': 'BACKGROUND', '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."}, {'pmid': '19039248', 'type': 'BACKGROUND', '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.'}, {'pmid': '21844495', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.', 'detailedDescription': '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.\n\nPatients enrolled into this study will be randomly assigned to one of two treatment groups:\n\n· Standard therapy consisting of 6 cycles of chemotherapy:\n\n* carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND\n* paclitaxel 175 mg/m2 given intravenously on day 1 every 3 weeks\n\nOR\n\n· Experimental therapy consisting of 6 cycles of chemotherapy:\n\n* carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND\n* liposomal doxorubicin 30 mg/m2 given intravenously on day 1 every 3 weeks'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cytologic / histologic diagnosis of stage Ic-IV ovarian cancer\n* Indication for chemotherapy treatment\n* Age 75 years or less\n* Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* 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)\n* Performance status (ECOG) \\> 2\n* Previous chemotherapy treatment\n* Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)\n* Leukocytes \\< 4000/mm3, neutrophils \\< 2000/mm3, platelets \\< 100000/mm3\n* Impaired renal function (creatinine \\> 1.25 times the upper normal limit) or liver function (SGOT or SGPT \\> 1.25 times the upper normal limit)\n* Present or suspected hemorrhagic syndromes\n* Uncooperative and/or unreliable patients\n* Patient's inability to access the center\n* Refusal of informed consent"}, 'identificationModule': {'nctId': 'NCT00326456', 'briefTitle': 'MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer', 'orgStudyIdInfo': {'id': 'MITO-2'}, 'secondaryIdInfos': [{'id': '2005-004453-98', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'carboplatin and liposomal doxorubicin', 'interventionNames': ['Drug: liposomal doxorubicin', 'Drug: carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'carboplatin and paclitaxel', 'interventionNames': ['Drug: carboplatin', 'Drug: paclitaxel']}], 'interventions': [{'name': 'liposomal doxorubicin', 'type': 'DRUG', 'description': '30 mg/m2 gieven intravenously on day 1 every 3 weeks', 'armGroupLabels': ['carboplatin and liposomal doxorubicin']}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'AUC 5 intravenously on day 1 every 3 weeks', 'armGroupLabels': ['carboplatin and liposomal doxorubicin', 'carboplatin and paclitaxel']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': '175 mg/m2 intravenously on day 1 every 3 weeks', 'armGroupLabels': ['carboplatin and paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83100', 'city': 'Avellino', 'state': 'AV', 'country': 'Italy', 'facility': 'Clinica Malzoni, Reparto di Ginecologia Oncologica', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': '83024', 'city': 'Monteforte Irpino', 'state': 'AV', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica', 'geoPoint': {'lat': 40.90246, 'lon': 14.744}}, {'zip': '70021', 'city': 'Acquaviva delle Fonti', 'state': 'BA', 'country': 'Italy', 'facility': 'Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica', 'geoPoint': {'lat': 40.89704, 'lon': 16.8433}}, {'zip': '70126', 'city': 'Bari', 'state': 'BA', 'country': 'Italy', 'facility': 'IRCCS Oncologico Bari, Oncologia Medica', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '70126', 'city': 'Bari', 'state': 'BA', 'country': 'Italy', 'facility': 'Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '24128', 'city': 'Bergamo', 'state': 'BG', 'country': 'Italy', 'facility': 'Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '82100', 'city': 'Benevento', 'state': 'BN', 'country': 'Italy', 'facility': 'Ospedale Fatebenefratelli, U.O. di Oncologia', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'zip': '40010', 'city': 'Bentivoglio', 'state': 'BO', 'country': 'Italy', 'facility': 'Ospedale di Bentivoglio', 'geoPoint': {'lat': 44.6369, 'lon': 11.41737}}, {'zip': '40139', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'Ospedale Bellari, U.O. di Oncologia', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40054', 'city': 'Budrio', 'state': 'BO', 'country': 'Italy', 'facility': 'Ospedale di Budrio', 'geoPoint': {'lat': 44.53745, 'lon': 11.53439}}, {'zip': '09042', 'city': 'Cagliari', 'state': 'CA', 'country': 'Italy', 'facility': 'Policlinico Universitario, Oncologia Medica II', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '86100', 'city': 'Campobasso', 'state': 'CB', 'country': 'Italy', 'facility': 'Università Cattolica del Sacro Cuore, Dipartimento di Oncologia', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'zip': '87100', 'city': 'Cosenza', 'state': 'CS', 'country': 'Italy', 'facility': 'Ospedale Mariano Santo, U.O. di Oncologia Medica', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'zip': '95126', 'city': 'Catania', 'state': 'CT', 'country': 'Italy', 'facility': 'Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '44100', 'city': 'Ferrara', 'state': 'FE', 'country': 'Italy', 'facility': "Azienda Ospedaliera Universitaria Acrispedale Sant'Anna", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '47100', 'city': 'Forlì', 'state': 'FO', 'country': 'Italy', 'facility': 'Ospedale Pierantoni, Divisione di Oncologia Medica', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'zip': '46100', 'city': 'Mantova', 'state': 'MN', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia', 'geoPoint': {'lat': 45.16031, 'lon': 10.79784}}, {'zip': '41012', 'city': 'Carpi', 'state': 'MO', 'country': 'Italy', 'facility': 'Ospedale Ramazzini, Day Hospital Oncologico', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}, {'zip': '90100', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Policlinico Universitario P. 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Chiara, U.O. di Oncologia Medica', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'zip': '10126', 'city': 'Torino', 'state': 'TO', 'country': 'Italy', 'facility': 'Ospedale S. Anna, Day Hospital Oncologico Divisione A', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '36100', 'city': 'Vicenza', 'state': 'VI', 'country': 'Italy', 'facility': 'Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera D. 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Giovanni Calibita Gatebenefratelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '3000', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'CHC Maternidade Bissaya-Barreto, Gynecology Unit', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Medical Oncology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Sandro Pignata, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Francesco Perrone, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}