Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum
- Registration Number
- NCT01705158
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- Brief Summary
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.
- Detailed Description
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®).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 87
-
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 platinum(deck).
-
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 criteria:
- 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 metastases.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description carboplatin and liposomal doxorubicin carboplatin and liposomal doxorubicin carboplatin and liposomal doxorubicin in ovarian cancer in realapse
- Primary Outcome Measures
Name Time Method Determine the control disease rate in 1 year 12 months 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)
- Secondary Outcome Measures
Name Time Method To estimate the rate of objective answer (CR/PR) 2,5 years * 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.
Trial Locations
- Locations (42)
Centre Catherine de Sienne
🇫🇷Nantes, France
Centre d'oncologie Saint-Yves
🇫🇷Vannes, France
Centre Hospitalier Départemental Les Oudairies
🇫🇷La Roche Sur Yon, France
Hôpital André Mignot
🇫🇷Le Chesnay, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Centre Hospitalier du Mans
🇫🇷Le Mans, France
Groupe Hospitalier Saint-Joseph
🇫🇷Paris, France
Centre Jean Perrin
🇫🇷Clermont-ferrand, France
CHU Dupuytren
🇫🇷Limoges, France
Hôpital Morvan - Centre Hospitalier Universitaire
🇫🇷Brest, France
Hopital de Scorff
🇫🇷Lorient, France
Clinique Tivoli
🇫🇷Bordeaux, France
Centre Léon bérard
🇫🇷Lyon, France
ICM Val d'Aurelle
🇫🇷Montpellier, France
Centre Azuréen de Cancérologie
🇫🇷Mougins, France
Centre Hospitalier Général de Pau
🇫🇷PAU Universite, France
Clinique Francheville
🇫🇷Perigueux, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-benite, France
Centre Hospitalier de la Région d'Annecy
🇫🇷Pringy, France
Centre intercommunal de Quimper
🇫🇷Quimper, France
Hôpital de Mont-de-Marsan
🇫🇷Mont-de-Marsan, France
Hopital privé Jean Mermoz
🇫🇷Lyon, France
Clinique Armoricaine
🇫🇷Saint-Brieuc, France
Clinique Mutualiste de l'Estuaire
🇫🇷Saint-nazaire, France
ICO René Gauducheau
🇫🇷St Herblain, France
Institut cancérologuie de la loire
🇫🇷St Priest en Jarez, France
Centre de Radiothérapie - Clinique Sainte-Anne
🇫🇷Strasbourg, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Centre Hospitalier General de Valenciennes
🇫🇷Valenciennes, France
Centre Hospitalier Bretagne Atlantique
🇫🇷Vannes, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre de Radiothérapie et d'Oncologie
🇫🇷Agen, France
Institut Bergonié
🇫🇷Bordeaux, France
Hopital des Diaconesses
🇫🇷Paris, France
Centre Paul Papin
🇫🇷Angers, France
Hôpital jean Minjoz
🇫🇷Besancon, France
Centre François Baclesse
🇫🇷Caen, France
Centre Hospitalier de Cholet
🇫🇷Cholet, France
Polyclinique KENVAL - Site de Valdegour
🇫🇷Nimes, France
Centre Hospitalier Régional d'Orléans
🇫🇷Orleans, France
Institut Jean Godinot
🇫🇷Reims, France
Centre hospitalier privé de Saint Grégoire
🇫🇷Saint Gregoire, France