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:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00326456
First received: May 15, 2006
Last updated: July 12, 2012
Last verified: July 2012
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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
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 12, 2012 |
| 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 |
Carboplatin Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013