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

Study Overview
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Brief Summary
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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
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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®).

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: carboplatin and liposomal doxorubicin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carboplatin and liposomal doxorubicin<br>carboplatin and liposomal doxorubicin in ovarian cancer in realapse | Drug: carboplatin and liposomal doxorubicin<br>* 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.<br>* Other names: liposomal doxorubicin, Myocet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2,5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer in relapse, sensitive in platin