Know Cancer

forgot password

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

Phase 1/Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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

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

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Gilles FREYER, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civiles de Lyon


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

October 2012

Completion Date:

June 2016

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer in relapse
  • sensitive in platin
  • Ovarian Neoplasms