Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer
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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
at 2 years
No
Sandro Pignata, M.D., Ph.D
Principal Investigator
National Cancer Institute, Naples
Italy: Ethics Committee
MITO-2
NCT00326456
January 2003
December 2013
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