Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed platinum-resistant Epithelial Ovarian Carcinoma (EOC)(clinical recurrence or persistence within 6 months of last treatment);
White blood cells >3,500/mm3, neutrophils ≥1,500/mm3, platelets ≥100,000/mm3;
Good renal function: serum creatinine values <1.5 mg/dl, creatinine clearance >60ml/min;
Performance Status ≤2, Karnofsky Index ≥70%;
Serum bilirubin ≤1.5 x Upper limit of normal (UNL) 2 mg/dl;
Prior ovarian surgery before starting study treatment;
Covered by a Healthcare System, where applicable, and/or in compliance with therecommendations of the national laws in force relating to biomedical research;
Signed written informed consent obtained prior to any study-specific screeningprocedures.
Exclusion
Exclusion Criteria:
Platinum-refractory EOC (i.e progression under platinum containing chemotherapy);
Any prior malignancy not considered in complete remission for at least 2 years;
Pregnancy or breastfeeding;
Untreated central nervous system disease or symptomatic central nervous systemmetastasis, history or evidence of thrombotic or hemorrhagic disorders within 6 monthsbefore first study treatment;
Uncontrolled hypertension or active clinically significant cardiovascular disease;
Females of childbearing age not using medically accepted contraceptive measures, asjudged by the investigator;
Contraindication to any drug contained in the chemotherapy regimen;
Known contraindication to cisplatin
Medical, geographical, sociological, psychological or legal conditions that wouldprevent the patient from completing the study or signing the informed consent;
Any significant disease which, in the investigator's opinion, excludes the patientfrom the study;
Under any administrative or legal supervision.
Study Design
Connect with a study center
Centre Hospitalier Universitaire Jean Minjoz
Besançon, 25030
FranceSite Not Available
CHRU Claude Huriez
Lille, 59067
FranceSite Not Available
Centre Oscar Lambret
Lille, 59000
FranceSite Not Available
Centre Léon Bérard
Lyon, 69008
FranceSite Not Available
Institut du Cancer de Montpellier
Montpellier, 34298
FranceSite Not Available
Centre Hospitalier Universitaire L'Archet II
Nice, 06200
FranceSite Not Available
Hôpital Européen Georges Pompidou - APHP
Paris, 75015
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre-Bénite,
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre-benite, 69495
FranceSite Not Available
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
FranceSite Not Available
Centre Hospitalier Universitaire de St Etienne
Saint-Priest-en-Jarez, 42270
FranceSite Not Available
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270
FranceSite Not Available
Centre Hospitalier Universitaire de St Etienne
Saint-priest-en-jarez, 42270
FranceSite Not Available
Centre Hospitalier Universitaire Hautepierre
Strasbourg, 67200
FranceSite Not Available
Institut de Cancérologie de Lorraine - Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
FranceSite Not Available
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