Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum
NCT ID: NCT01705158
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
87 participants
INTERVENTIONAL
2012-10-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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carboplatin and liposomal doxorubicin
carboplatin and liposomal doxorubicin in ovarian cancer in realapse
carboplatin and liposomal doxorubicin
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.
Interventions
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carboplatin and liposomal doxorubicin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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Principal Investigators
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Gilles FREYER, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civiles de Lyon
Locations
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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
Hôpital André Mignot
Le Chesnay, , France
Centre Hospitalier du Mans
Le Mans, , France
Centre Oscar Lambret
Lille, , France
CHU Dupuytren
Limoges, , France
Hopital de Scorff
Lorient, , France
Centre Léon bérard
Lyon, , France
Hopital privé Jean Mermoz
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Hôpital de Mont-de-Marsan
Mont-de-Marsan, , France
ICM Val d'Aurelle
Montpellier, , France
Centre Azuréen de Cancérologie
Mougins, , France
Centre Catherine de Sienne
Nantes, , France
Polyclinique KENVAL - Site de Valdegour
Nîmes, , France
Centre Hospitalier Régional d'Orléans
Orléans, , France
Groupe Hospitalier Saint-Joseph
Paris, , France
Hopital des Diaconesses
Paris, , France
Centre Hospitalier Général de Pau
PAU Universite, , France
Clinique Francheville
Périgueux, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier de la Région d'Annecy
Pringy, , France
Centre intercommunal de Quimper
Quimper, , France
Institut Jean Godinot
Reims, , France
Clinique Armoricaine
Saint-Brieuc, , France
Centre hospitalier privé de Saint Grégoire
Saint-Grégoire, , France
ICO René Gauducheau
Saint-Herblain, , France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, , France
Institut cancérologuie de la loire
Saint-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 d'oncologie Saint-Yves
Vannes, , France
Centre Hospitalier Bretagne Atlantique
Vannes, , France
Countries
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References
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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.
Other Identifiers
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2012-001999-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MYCA (GINECO-OV220)
Identifier Type: -
Identifier Source: org_study_id
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