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

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: carboplatin and liposomal doxorubicin

• Registration Number: NCT01705158
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Primary Completion: 2014-10
• Study Completion: 2017-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
carboplatin and liposomal doxorubicin	carboplatin and liposomal doxorubicin	carboplatin and liposomal doxorubicin in ovarian cancer in realapse

Primary Outcome Measures

Name	Time	Method
Determine the control disease rate in 1 year	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

Name	Time	Method
To estimate the rate of objective answer (CR/PR)	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.

Trial Locations

Locations (42)

Centre de Radiothérapie et d'Oncologie; 🇫🇷 Agen, France

Centre Paul Papin; 🇫🇷 Angers, France

Hôpital jean Minjoz; 🇫🇷 Besancon, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Hôpital Morvan - Centre Hospitalier Universitaire; 🇫🇷 Brest, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Hospitalier de Cholet; 🇫🇷 Cholet, France

Centre Jean Perrin; 🇫🇷 Clermont-ferrand, France

Centre Hospitalier Départemental Les Oudairies; 🇫🇷 La Roche Sur Yon, France

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