Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum
- First or second relapse of a carcinoma of the ovary, the fallopian tubes or the
peritoneal tissue histological proved.
- Interval without progress > 6 months after the last administration of a salt of
- Measurable Disease (according to the criteria RECIST 1.1) or an assessable disease
according to CA-125 (according to the criteria of the GCIG).
- Satisfactory biological Balance sheet(Assessment), according to the following
- Neutrophiles > 1,5x 109/L, Plaques > 100 x 109/L, Haemoglobin > 9,0 g/dL.
- Bilirubine < 1.5 x LSN (Normal Superior Limit), transaminases and alkaline
phosphatase < 2. 5 x LSN.
- Creatinin clearance > 50 mL/min calculated according to the formula of
Cockroft-Gault or MDRD.
- Performance status < 2.
- Life expectancy of at least 12 weeks.
- Age > 18 years.
- Capacity to follow the protocol.
- Consent signed before any procedure of inclusion.
- Membership in a national insurance scheme.
- Tumor of mild histology or borderline, or malignant not epithelial tumor of the
ovary, the fallopian tubes or the peritoneal tissue(eg. tumor of germ cells, tumor of
the sexual cords and the stroma).
- History of abdominal or pelvic radiotherapy.
- Patient having received more than 2 lines of chemotherapy.
- Patient in 3rd relapse or more.
- History of another malignant tumor during the last 5 years, with the exception of a
carcinoma in situ by the neck of the womb or by a squamous-cell carcinoma of the skin
treated in a adequate way or any solid tumor considered in forgiveness completes
without relapse for at least 5 years.
- Patients having a stubborn illness in the platinum, (eg. progress during the last
chemotherapy or in 6 months following the last administration of platinum).
- Occlusive or sub-occlusive disease or presence of symptomatic intellectual
- Heart disorder dissuading the use of an anthracycline.
- Left venticular ejection fraction (LVEF) defined by MUGA/ECHO < 50%.
- Wait presenting a severe infection.
- Woman old enough to procreate not using adequate contraceptive method.
- Concomitant disease not allowing a surgery and/or a chemotherapy.
- Pathology severe or concomitant not compatible with the taking of the study treatment
or the participation of the patient in the study.