Assessment of cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in first or secondary platinum-resistant recurrent ovarian epithelial cancer.HIPOVA-01

Phase 1

• Conditions: Patients with First or second recurrence of platin-resistant epithelial ovarian cancer; MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002480-94-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

-18 < age = 75 years;
-First or second recurrence of platin-resistant epithelial ovarian cancer (clinical recurrence or persistence within 6 months of last treatment);
-White Blood cell Count >3,500/mm3, neutrophils =1,500/mm3, platelets =100,000/mm3;
-Good renal function: CKD-EPI >60 ml/min/1.73 m²;
-Eastern Cooperative Oncology Group Performance Status (ECOG PS) =2;
-Serum bilirubin =1.5 x Upper Limit of Normal (ULN);
-Prior debulking surgery whatever the residue
-Information on the residue of the debulking surgery available (R0 or R+)
-Treated with a maximum of two previous lines of chemotherapy
-Covered by a Healthcare System;
-Signed written informed consent obtained prior to any study-specific screening procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-Platinum-refractory EOC (i.e. progression under platinum containing chemotherapy);
-History of breast cancer or previous malignancies not considered in complete remission for at least 2 years;
-Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start);
-Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using highly-effective, hormonal or non-hormonal means of contraception (i.e. intrauterine contraceptive device) during the study and for 6 months after the last dose of study medication;
-Untreated central nervous system disease or symptomatic central nervous system metastasis;
-History or evidence of thrombotic or haemorrhagic disorders within 6 months before first study treatment;
-Uncontrolled hypertension (sustained systolic = 140 mmHg and/or diastolic = 90 mmHg confirmed by 2 measures despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified