Cytoreductive Surgery and HIPEC in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer

Launched by HOSPICES CIVILS DE LYON · Jul 17, 2017

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• 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 \>60 ml/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 the recommendations of the national laws in force relating to biomedical research;
• • Signed written informed consent obtained prior to any study-specific screening procedures.
• 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 system metastasis, history or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment;
• • Uncontrolled hypertension or active clinically significant cardiovascular disease;
• • Females of childbearing age not using medically accepted contraceptive measures, as judged by the investigator;
• • Contraindication to any drug contained in the chemotherapy regimen;
• • Known contraindication to cisplatin
• • Medical, geographical, sociological, psychological or legal conditions that would prevent the patient from completing the study or signing the informed consent;
• • Any significant disease which, in the investigator's opinion, excludes the patient from the study;
• • Under any administrative or legal supervision.