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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705158
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin and liposomal doxorubicin Phase 1 Phase 2

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®).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : April 2017


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705158


Locations
Show Show 42 study locations
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
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Principal Investigator: Gilles FREYER, Dr Hospices Civiles de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01705158    
Other Study ID Numbers: MYCA (GINECO-OV220)
2012-001999-10 ( EudraCT Number )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Keywords provided by ARCAGY/ GINECO GROUP:
ovarian cancer in relapse
sensitive in platin
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Recurrence
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Immune System Diseases
Carboplatin
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action