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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
820
30 mg/m2 gieven intravenously on day 1 every 3 weeks
AUC 5 intravenously on day 1 every 3 weeks
175 mg/m2 intravenously on day 1 every 3 weeks
Progression free survival
Time frame: at 2 years
overall survival
Time frame: 4 years
quality of life
Time frame: at baseline and every 3 weeks during treatment
objective response rate
Time frame: at 9 and 18 weeks after starting study therapy
adverse events
according to CTCAE criteria
Time frame: every 3 weeks during chemotherapy
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Clinica Malzoni, Reparto di Ginecologia Oncologica
Avellino, AV, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Bari, BA, Italy
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
Bergamo, BG, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy
Ospedale di Bentivoglio
Bentivoglio, BO, Italy
Ospedale Bellari, U.O. di Oncologia
Bologna, BO, Italy
Ospedale di Budrio
Budrio, BO, Italy
...and 28 more locations