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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hôpital Jean Minjoz
      • Bordeaux, France
        • Institut Bergonie
      • 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 Departemental 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 Régional D'orléans
      • PAU Universite, France
        • Centre Hospitalier Général 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 Rene Gauducheau
      • St Priest en Jarez, France
        • Institut cancérologuie de la loire
      • Strasbourg, France
        • Hopitaux 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCAGY/ GINECO GROUP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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