The purpose of this study is to determine the efficacy and the safety of the association of carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive to platin.
In front of a shortage of Caelyx, the implementation of an alternative treatment must be considered to treat patients with ovarian cancer in relapse, sensitive to platin: associate the carboplatin with another drug of the family of the doxorubicin: liposomal doxorubicin (Myocet®).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Carboplatin AUC5 and liposomal doxorubicin 40 or 50 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.
Determine the control disease rate in 1 year
To determine the proportion of not progressive patients in 1 year (rate of control of the disease or the rate of not progress in 12 months)
Time frame: 12 months
To estimate the rate of objective answer (CR/PR)
* To estimate the survival without progress (PFS) * To estimate the overal survival (OS) * To estimate the profile of toxicity of the association. * Quality of life. * Validation of the clearance of CA-125 as predictive marker of the efficiency of the treatment and as factor forecast of the survival.
Time frame: 2,5 years
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Centre de Radiothérapie et d'Oncologie
Agen, France
Centre Paul Papin
Angers, France
Hôpital jean Minjoz
Besançon, France
Clinique Tivoli
Bordeaux, France
Institut Bergonié
Bordeaux, France
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, France
Centre François Baclesse
Caen, France
Centre Hospitalier de Cholet
Cholet, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France
...and 32 more locations