Clinical trial NCT01705158: Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum
Official title: Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Keywords: ovarian cancer in relapse
sensitive in platin
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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®).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Determine the control disease rate in 1 year
timeFrame: 12 months
Secondary outcomes:
measure: To estimate the rate of objective answer (CR/PR)
timeFrame: 2,5 years
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre de Radiothérapie et d'Oncologie
city: Angers
country: France
facility: Centre Paul Papin
city: Besancon
country: France
facility: Hôpital jean Minjoz
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: Hôpital Morvan - Centre Hospitalier Universitaire
city: Caen
country: France
facility: Centre François Baclesse
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Départemental Les Oudairies
city: Le Chesnay
country: France
facility: Hôpital André Mignot
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: CHU Dupuytren
city: Lorient
country: France
facility: Hopital de Scorff
city: Lyon
country: France
facility: Centre Léon bérard
city: Lyon
country: France
facility: Hopital privé Jean Mermoz
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Mont-de-Marsan
country: France
facility: Hôpital de Mont-de-Marsan
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nimes
country: France
facility: Polyclinique KENVAL - Site de Valdegour
city: Orleans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Paris
country: France
facility: Groupe Hospitalier Saint-Joseph
city: Paris
country: France
facility: Hopital des Diaconesses
city: PAU Universite
country: France
facility: Centre Hospitalier Général de Pau
city: Perigueux
country: France
facility: Clinique Francheville
city: Pierre-benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Pringy
country: France
facility: Centre Hospitalier de la Région d'Annecy
city: Quimper
country: France
facility: Centre intercommunal de Quimper
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Gregoire
country: France
facility: Centre hospitalier privé de Saint Grégoire
city: Saint-Brieuc
country: France
facility: Clinique Armoricaine
city: Saint-nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: St Herblain
country: France
facility: ICO René Gauducheau
city: St Priest en Jarez
country: France
facility: Institut cancérologuie de la loire
city: Strasbourg
country: France
facility: Centre de Radiothérapie - Clinique Sainte-Anne
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Valenciennes
country: France
facility: Centre Hospitalier General de Valenciennes
city: Vannes
country: France
facility: Centre d'oncologie Saint-Yves
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
Study officials:
affiliation: Hospices Civiles de Lyon
name: Gilles FREYER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romeo C, Joly F, Ray-Coquard I, El Kouri C, Mercier-Blas A, Berton-Rigaud D, Kalbacher E, Cojocarasu O, Fabbro M, Cretin J, Zannetti A, Abadie-Lacourtoisie S, Mollon D, Hardy-Bessard AC, Provansal M, Blot E, Delbaldo C, Lesoin A, Freyer G, You B. Non-pegylated liposomal doxorubicin (NPLD, Myocet(R)) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial. Gynecol Oncol. 2019 Jan;152(1):68-75. doi: 10.1016/j.ygyno.2018.10.043. Epub 2018 Nov 14.