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Ovarian CancerPhase 1/2MYCANCT01705158

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

A Phase 1/2 study testing carboplatin and liposomal doxorubicin in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 42 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
carboplatin and liposomal doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
42 sitesFrance
Study dates
Oct 2012to Apr 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

France42 sites

  • Centre de Radiothérapie et d'Oncologie

    Agen

  • Centre Paul Papin

    Angers

  • Hôpital jean Minjoz

    Besançon

  • Clinique Tivoli

    Bordeaux

  • Institut Bergonié

    Bordeaux

  • Hôpital Morvan - Centre Hospitalier Universitaire

    Brest, 29200

  • Centre François Baclesse

    Caen

  • Centre Hospitalier de Cholet

    Cholet

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon

  • Hôpital André Mignot

    Le Chesnay

  • Centre Hospitalier du Mans

    Le Mans

  • Centre Oscar Lambret

    Lille

  • CHU Dupuytren

    Limoges

  • Hopital de Scorff

    Lorient

  • Centre Léon bérard

    Lyon

  • Hopital privé Jean Mermoz

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • Hôpital de Mont-de-Marsan

    Mont-de-Marsan

  • ICM Val d'Aurelle

    Montpellier

  • Centre Azuréen de Cancérologie

    Mougins

  • Centre Catherine de Sienne

    Nantes

  • Polyclinique KENVAL - Site de Valdegour

    Nîmes

  • Centre Hospitalier Régional d'Orléans

    Orléans

  • Groupe Hospitalier Saint-Joseph

    Paris

  • Hopital des Diaconesses

    Paris

  • Centre Hospitalier Général de Pau

    PAU Universite

  • Clinique Francheville

    Périgueux

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre Hospitalier de la Région d'Annecy

    Pringy

  • Centre intercommunal de Quimper

    Quimper

  • Institut Jean Godinot

    Reims

  • Clinique Armoricaine

    Saint-Brieuc, 22015

  • Centre hospitalier privé de Saint Grégoire

    Saint-Grégoire

  • ICO René Gauducheau

    Saint-Herblain

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire

  • Institut cancérologuie de la loire

    Saint-Priest-en-Jarez

  • Centre de Radiothérapie - Clinique Sainte-Anne

    Strasbourg, 67000

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • Centre Hospitalier General de Valenciennes

    Valenciennes

  • Centre d'oncologie Saint-Yves

    Vannes

  • Centre Hospitalier Bretagne Atlantique

    Vannes

Other trials in France

About this study

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

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.

Read the 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®).

Conditions
Ovarian Cancer
Being tested
carboplatin and liposomal doxorubicin
Keywords
ovarian cancer in relapse, sensitive in platin
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatin and liposomal doxorubicinDrug

    Also called carboplatin, liposomal doxorubicin, Myocet

    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.

Study groups in NCT01705158
Study groupRoleWhat they receive
carboplatin and liposomal doxorubicinExperimentalcarboplatin and liposomal doxorubicin in ovarian cancer in realapse
Receives: Drug: carboplatin and liposomal doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 months

Secondary outcomes (1)

  1. 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.

    Measured: 2,5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2014
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705158
Sponsor's protocol ID
MYCA (GINECO-OV220)
Other IDs
2012-001999-10
Acronym
MYCA
Status last verified
Sep 2023
First submitted
1 Oct 2012
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30446275

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing carboplatin and liposomal doxorubicin in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 42 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the control disease rate in 1 year (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01705158, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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