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| 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: | 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 |
| Estimated Enrollment: | 820 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | July 2010 (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
|
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:
OR
· Experimental therapy consisting of 6 cycles of chemotherapy:
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| 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 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 | |
| Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico | |
| Palermo, PA, Italy, 90146 | |
| Policlinico Universitario P. Giaccone | |
| Palermo, PA, Italy, 90100 | |
| 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 | |
| Azienda Ospedaliera D. Cotugno | |
| Napoli, Italy, 80131 | |
| Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B | |
| Napoli, Italy, 80131 | |
| Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C | |
| 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 | |
| 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
| Responsible Party: | Sandro Pignata, M.D., Ph.D, NCI Naples |
| ClinicalTrials.gov Identifier: | NCT00326456 History of Changes |
| Other Study ID Numbers: | MITO-2, EudraCT number 2005-004453-98 |
| Study First Received: | May 15, 2006 |
| Last Updated: | February 1, 2010 |
| Health Authority: | Italy: Ethics Committee |
|
ovarian cancer chemotherapy first-line |
|
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 |