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

September 5, 2023 updated by: ARCAGY/ GINECO GROUP

Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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®).

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France
        • Centre de Radiothérapie et d'Oncologie
      • Angers, France
        • Centre Paul Papin
      • Besancon, France
        • Hopital Jean Minjoz
      • Bordeaux, France
        • Institut Bergonié
      • Bordeaux, France
        • Clinique Tivoli
      • Brest, France, 29200
        • Hôpital Morvan - Centre Hospitalier Universitaire
      • Caen, France
        • Centre Francois Baclesse
      • Cholet, France
        • Centre Hospitalier de Cholet
      • Clermont-ferrand, France
        • Centre Jean Perrin
      • La Roche Sur Yon, France
        • Centre Hospitalier Départemental Les Oudairies
      • Le Chesnay, France
        • Hôpital André Mignot
      • Le Mans, France
        • Centre Hospitalier du Mans
      • Lille, France
        • Centre Oscar Lambret
      • Limoges, France
        • Chu Dupuytren
      • Lorient, France
        • Hopital de Scorff
      • Lyon, France
        • Centre Leon Berard
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Marseille, France
        • Institut Paoli Calmettes
      • Mont-de-Marsan, France
        • Hôpital de Mont-de-Marsan
      • Montpellier, France
        • ICM Val D'Aurelle
      • Mougins, France
        • Centre Azuréen de Cancérologie
      • Nantes, France
        • Centre Catherine de Sienne
      • Nimes, France
        • Polyclinique KENVAL - Site de Valdegour
      • Orleans, France
        • Centre Hospitalier Regional D'Orleans
      • PAU Universite, France
        • Centre Hospitalier General de Pau
      • Paris, France
        • Hôpital des Diaconesses
      • Paris, France
        • Groupe Hospitalier Saint-Joseph
      • Perigueux, France
        • Clinique Francheville
      • Pierre-benite, France
        • Centre Hospitalier Lyon Sud
      • Pringy, France
        • Centre Hospitalier de la Région d'Annecy
      • Quimper, France
        • Centre intercommunal de Quimper
      • Reims, France
        • Institut Jean Godinot
      • Saint Gregoire, France
        • Centre hospitalier privé de Saint Grégoire
      • Saint-Brieuc, France, 22015
        • Clinique Armoricaine
      • Saint-nazaire, France
        • Clinique Mutualiste de l'Estuaire
      • St Herblain, France
        • ICO René Gauducheau
      • St Priest en Jarez, France
        • Institut cancérologuie de la loire
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67000
        • Centre de Radiothérapie - Clinique Sainte-Anne
      • Valenciennes, France
        • Centre Hospitalier General de Valenciennes
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique
      • Vannes, France
        • Centre d'Oncologie Saint-Yves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carboplatin and liposomal doxorubicin
carboplatin and liposomal doxorubicin in ovarian cancer in realapse
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.
Other Names:
  • carboplatin
  • liposomal doxorubicin, Myocet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the control disease rate in 1 year
Time Frame: 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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the rate of objective answer (CR/PR)
Time Frame: 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.
2,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Gilles FREYER, Dr, Hospices Civiles de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimated)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYCA (GINECO-OV220)
  • 2012-001999-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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