Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum
MYCA
Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum
2 other identifiers
interventional
87
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 ovarian-cancer
Started Oct 2012
Typical duration for phase_1 ovarian-cancer
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedSeptember 6, 2023
September 1, 2023
2 years
October 1, 2012
September 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
12 months
Secondary Outcomes (1)
To estimate the rate of objective answer (CR/PR)
2,5 years
Study Arms (1)
carboplatin and liposomal doxorubicin
EXPERIMENTALcarboplatin and liposomal doxorubicin in ovarian cancer in realapse
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- Membership in a national insurance scheme.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
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, 29200, 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, 22015, 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, 67000, 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
Related Publications (1)
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.
PMID: 30446275DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilles FREYER, Dr
Hospices Civiles de Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 12, 2012
Study Start
October 1, 2012
Primary Completion
October 1, 2014
Study Completion
April 1, 2017
Last Updated
September 6, 2023
Record last verified: 2023-09