This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (\> 6 months).
The main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. And it is hoped that substituting paclitaxel with Caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
976
30 mg/m² every 4 weeks during 6 cycles or until progression
AUC 5 every 3/4 weeks during 6 cycles or until progression
175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression
Hôpital Hôtel Dieu
Paris, France
Progression-free survival of patients in both study groups
Time frame: 5 years
Qualitative and quantitative toxicities
Time frame: 6 months
Quality of life
Time frame: 6 months
Overall survival
Time frame: 5 years
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