Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum

Ovarian Cancer Clinical Trial

— MYCA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705158
• Other study ID #: MYCA (GINECO-OV220)
• Secondary ID: 2012-001999-10
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2012
• Est. completion date: April 2017

Study information

• Verified date: September 2023
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Cancer
• Ovarian Neoplasms
• Recurrence

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	Centre de Radiothérapie et d'Oncologie	Agen
France	Centre Paul Papin	Angers
France	Hôpital jean Minjoz	Besancon
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	Nimes
France	Centre Hospitalier Régional d'Orléans	Orleans
France	Groupe Hospitalier Saint-Joseph	Paris
France	Hopital des Diaconesses	Paris
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	Institut Jean Godinot	Reims
France	Centre hospitalier privé de Saint Grégoire	Saint Gregoire
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 d'oncologie Saint-Yves	Vannes
France	Centre Hospitalier Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To estimate the rate of objective answer (CR/PR)	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.	2,5 years