Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatment carboplatin and liposomal doxorubicin
Phase phase 1/phase 2
Sponsor ARCAGY/ GINECO GROUP
Start date October 2012
End date October 2014
Trial size 87 participants
Trial identifier NCT01705158, 2012-001999-10, MYCA (GINECO-OV220)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
carboplatin and liposomal doxorubicin in ovarian cancer in realapse
carboplatin and liposomal doxorubicin carboplatin
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.

Primary Outcomes

Measure
Determine the control disease rate in 1 year
time frame: 12 months

Secondary Outcomes

Measure
To estimate the rate of objective answer (CR/PR)
time frame: 2,5 years

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Gilles FREYER, Dr
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®).
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by ARCAGY/ GINECO GROUP.