Carboplatin + paclitaxel vs carboplatin + stealth liposomal doxorubicin. A randomised multicentre trial.

INTERVENTION: Product Name: Pegylated Liposomal Doxorubicin Product Code: 9254 Pharmaceutical Form: Concentrate for solution for infusion Product Name: Carboplatin Pharmaceutical Form: Concentrate for solution for infusion Product Name: Paclitaxel Product Code: L01CD01 Pharmaceutical Form: CONDITION: Recurrent ovarian cancer Cytologic / histologic diagnosis of stage IC‐IV ovarian cancer PRIMARY OUTCOME: Main Objective: To compare the efficacy of the experimental combination (carboplatin + liposomal; doxorubicin), with the efficacy of the standard combination (carboplatin + paclitaxel),; as first‐line treatment of ovarian cancer patients. Primary end point(s): Primary end‐point; To compare the efficacy, in terms of progression‐free survival (PFS) of the; experimental combination of carboplatin + liposomal doxorubicin, compared with the; standard combination of carboplatin + paclitaxel, in the first line treatment of ovarian; cancer patients.; Secondary Objective: Toxicity.; INCLUSION CRITERIA: Inclusion criteria *Cytologic / histologic diagnosis of stage IC‐IV ovarian cancer *Indication for chemotherapy treatment *Age < 75 years. *Life expectancy of at least 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range