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Completed

NCT Number: NCT01705158

Myocet ® - Carboplatine in Ovarian Cancer 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre de Radiothérapie et d'Oncologie, Agen, France

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About this study

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®).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carboplatin and liposomal doxorubicin

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study title

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

Acronym: MYCA

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Oct 12, 2012
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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