Clinical Trials Register

Summary
EudraCT Number:	2015-000418-23
Sponsor's Protocol Code Number:	AGO/2015/002
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-06-04
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2015-000418-23

A.3

Full title of the trial

Intraoperative intraperitoneal chemoperfusion to treat peritoneal minimal residual disease in stage III ovarian cancer: a randomized phase II trial.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Intraoperatieve intraperitoneale Chemoperfusie voor de behandeling van minimale residuele ziekte bij stadium III Eierstokkanker: een gerandomiseerde fase II studie.

A.4.1

Sponsor's protocol code number

AGO/2015/002

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Ghent University Hospital
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ghent University Hospital
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Ghent University Hospital
B.5.2	Functional name of contact point	Bimetra Clinics
B.5.3	Address:
B.5.3.1	Street Address	De Pintelaan 185
B.5.3.2	Town/ city	Ghent
B.5.3.3	Post code	9000
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3293320500
B.5.5	Fax number	+3293320520
B.5.6	E-mail	bimetra.clinics@uzgent.be

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cisplatin Hospira
D.2.1.1.2	Name of the Marketing Authorisation holder	Hospira Benelux BVBA
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cisplatine Hospira
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cisplatine Hospira
D.3.9.3	Other descriptive name	CISPLATIN
D.3.9.4	EV Substance Code	SUB07483MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	75 to 100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Physioneal
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Physioneal 35 Glucose 1.36%
D.3.4	Pharmaceutical form	Solution for peritoneal dialysis
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Glucosemonohydraat
D.3.9.3	Other descriptive name	GLUCOSE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB13983MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Natriumchloride
D.3.9.3	Other descriptive name	SODIUM CHLORIDE SOLUTION 0.9%
D.3.9.4	EV Substance Code	SUB20079
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5.67
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	calciumchloridedihydraat
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE DIHYDRATE
D.3.9.4	EV Substance Code	SUB12664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.257
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	magnesiumchloridehexahydraat
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.051
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	natriumbicarbonaat
D.3.9.1	CAS number	144-55-8
D.3.9.3	Other descriptive name	SODIUM HYDROGEN CARBONATE
D.3.9.4	EV Substance Code	SUB12290MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Natrium-(S)-lactaatoplossing
D.3.9.3	Other descriptive name	SODIUM LACTATE
D.3.9.4	EV Substance Code	SUB15300MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.12
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

stage III ovarian cancer

E.1.1.1

Medical condition in easily understood language

stage III ovarian cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To study the effect of cytoreductive surgery (CRS) and efficacy of cisplatin-based intraoperative intraperitoneal chemoperfusion (IPEC) in patients with primary or recurrent serous epithelial ovarian cancer (OC), in order to treat peritoneal minimal residual disease (pMRD).

E.2.2

Secondary objectives of the trial

To study the pharmacodynamics of IP drug delivery and the value of hyperthermic administration.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

 Tumor type
o Biopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma
 Primary or recurrent disease
 Extent of disease
o Positive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III)
o Stage IV with unilateral pleural fluid allowed
o Complete or nearly complete macroscopic cytoreduction at the time of surgery (CC-0 or CC-1) deemed possible based on imaging, laparoscopy, or both
 Second-line patients; platinum sensitive
 Age over 18 years
 No major cardiac or respiratory disease
 Absent or limited (<500ml) clinical ascites
 Adequate performance status (Karnofsky index > 70%)
 Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
 Expected life expectancy more than 6 months
 Laboratory data
o Serum creatinine  1.5 mg/dl or a calculated GFR (CKD-EPI) ≥ 60 mL/min/1.73 m2
o Serum total bilirubin  1.5 mg/dl, except for known Gilbert’s disease
o Platelet count > 100.000/µl
o Hemoglobin > 9g/dl
o Neutrophil granulocytes > 1.500/ml
o International Normalized Ratio (INR)  2
 Absence of alcohol and/or drug abuse
 No other concurrent malignant disease
 No inclusion in other clinical trials interfering with the study protocol
 No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy
 Absence of any severe organ insufficiency
 No pregnancy or breast feeding
 Written informed consent

E.4

Principal exclusion criteria

 Severe or uncontrolled cardiac insufficiency, including recent (< 6 months) occurrence of myocardial infarction, the presence of congestive cardiac insufficiency, of symptomatic angor in spite of optimal medical care, of cardiac arrhythmia requiring medical treatment presenting insufficient rhythm control, or uncontrolled arterial hypertension
 Pregnancy or breast feeding
 Platinum resistant (relapse > 12 months after completion of Pt containing therapy) or refractory disease
 Active bacterial, viral or fungal infection
 Active gastro-duodenal ulcer
 Parenchymal liver disease (any stage cirrhosis)
 Uncontrolled diabetes mellitus
 Severe obstructive or restrictive respiratory insufficiency
 Psychiatric pathology capable of affecting comprehension and judgment faculty
 Tumor in the presence of obstruction
 Evidence of extra-abdominal disease (with the exception of unilateral malignant pleural effusion) or extensive liver metastasis
 Peritoneal cancer index (sPCI) ≥ 25

E.5 End points

E.5.1

Primary end point(s)

Tissue penetration distance of cisplatin in peritoneal tumor tissue nodules

E.5.1.1

Timepoint(s) of evaluation of this end point

end of surgery

E.5.2

Secondary end point(s)

o Postoperative morbidity and mortality
o Quality of Life
o Pharmacokinetics of cisplatin in peritoneal perfusate and plasma samples
o Pharmacodynamics: Pt DNA adduct formation
o Overall survival, disease free survival, peritoneal recurrence free survival
o Effects of (H)IPEC on peritoneal cytology
o Translational research: analyzing gene expression of selected biomarkers for Pt sensitivity, stromal density and composition of tumor slices.

E.5.2.1

Timepoint(s) of evaluation of this end point

o Postoperative morbidity and mortality: 30 days after debulking
o Quality of Life: preoperatively, after 6 weeks and after 3, 6, 12, 18 and 24 months.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

standard treatment of the condition

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-06-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-08-25

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