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LifePearl-Iri Pharmacokinetic Study

Primary Purpose

Metastatic Colorectal Cancer, mCRC

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

TACE with irinotecan loaded LifePearl

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring liver, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is at least 18 years old
Histologically proven mCRC
At least 1 measurable liver metastasis > 1 cm (mRECIST) Liver predominant disease ( ≥ 80% of metastatic disease confined to the liver)
No portal vein involvement
Performance status 0 or 1
Life Expectancy ≥ 3m
Adequate Hematologic function (ANC≥1.5 10^9/l; PLT≥75 10^9/l; INR (international normalized ratio) ≤1.3)
Adequate liver and renal function (Total bilirubin ≤2.0 mg/dl; ALBUMINE 2.5g/dl; Serum creatinine ≤2.0 mg/dl; ALT (alanine transaminase),AST (aspartate transaminase) ≤5 times ULN)
Less than 50% liver tumor replacement
Patient has provided written informed consent
Patient is affiliated to social security or equivalent system (France only)

Exclusion Criteria:

Eligible for curative treatment (resection/RFA) History of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment)
Previous liver embolization
Contraindication for intra-arterial embolization and local irinotecan administration
Allergy to contrast media
Patient is co-treated with potent CYP3A4/UGT1A1 (cytochrome P450 3A4/uridine diphosphate glucuronosyltransferase 1A1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and St John's Wort
Patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
Patient is under judicial protection (France only)

Sites / Locations

KUL
SLK-Kliniken Heilbronn GmbH
Klinikum Bogenhausen, Städt. Klinikum München GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TACE with irinotecan loaded LifePearl

Arm Description

10 patients receiving unilobar treatment: day 1=chemoembolization of first lobe of liver, day 14=chemoembolization of second lobe of liver, day 30=chemoembolization of first lobe of liver, day 44= chemoembolization of second lobe of liver; AND 10 patient receiving bilobar treatment: day 1=chemoembolization of both lobes of the liver, day 30=chemoembolization of both lobes of the liver

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38

Time to reach Cmax (Tmax)

Tmax will be estimated directly from concentration-time data

Area Under the Curve (AUC)

The trapezoidal rule will be used to calculate the area under the curve over 24 hours

Secondary Outcome Measures

Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment

Overall Survival

Progression-Free Survival

Response rate

Response rate (mRECIST criteria) 3 months after the first treatment

Technical success - treatment delivery

Ability to deliver ≥75% of the planned dose during the first chemoembolization

Technical success - total dose delivered

Sum of all doses delivered during the course of the study

Full Information

NCT ID

NCT02547480

First Posted

August 27, 2015

Last Updated

November 23, 2017

Sponsor

Terumo Europe N.V.

Collaborators

Federation Francophone de Cancerologie Digestive, Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT02547480

Brief Title

LifePearl-Iri Pharmacokinetic Study

Official Title

Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

April 28, 2017 (Actual)

Study Completion Date

September 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Terumo Europe N.V.

Collaborators

Federation Francophone de Cancerologie Digestive, Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer, mCRC

Keywords

liver, metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TACE with irinotecan loaded LifePearl

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

TACE with irinotecan loaded LifePearl

Other Intervention Name(s)

TACE

Intervention Description

Arterial embolization will be performed through lobar infusion and using a microcatheter. LifePearl microspheres of 200 µm will be used as preferred beads. They will be loaded with the appropriate dose of irinotecan hydrochloride injectable solution, mixed with the contrast media and distributed to the targeted lobe. The targeted dose is 100 mg of irinotecan per lobe treated, meaning that when treated unilobarly at baseline the total dose received will be 100 mg ( all in one lobe) and in during bilobar treatment, 200 mg in both lobes.

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Description

Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38

Time Frame

2 days

Title

Time to reach Cmax (Tmax)

Description

Tmax will be estimated directly from concentration-time data

Time Frame

2 days

Title

Area Under the Curve (AUC)

Description

The trapezoidal rule will be used to calculate the area under the curve over 24 hours

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment

Time Frame

1 month

Title

Overall Survival

Time Frame

12 months

Title

Progression-Free Survival

Time Frame

12 months

Title

Response rate

Description

Response rate (mRECIST criteria) 3 months after the first treatment

Time Frame

3 months

Title

Technical success - treatment delivery

Description

Ability to deliver ≥75% of the planned dose during the first chemoembolization

Time Frame

1 day

Title

Technical success - total dose delivered

Description

Sum of all doses delivered during the course of the study

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is at least 18 years old Histologically proven mCRC At least 1 measurable liver metastasis > 1 cm (mRECIST) Liver predominant disease ( ≥ 80% of metastatic disease confined to the liver) No portal vein involvement Performance status 0 or 1 Life Expectancy ≥ 3m Adequate Hematologic function (ANC≥1.5 10^9/l; PLT≥75 10^9/l; INR (international normalized ratio) ≤1.3) Adequate liver and renal function (Total bilirubin ≤2.0 mg/dl; ALBUMINE 2.5g/dl; Serum creatinine ≤2.0 mg/dl; ALT (alanine transaminase),AST (aspartate transaminase) ≤5 times ULN) Less than 50% liver tumor replacement Patient has provided written informed consent Patient is affiliated to social security or equivalent system (France only) Exclusion Criteria: Eligible for curative treatment (resection/RFA) History of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment) Previous liver embolization Contraindication for intra-arterial embolization and local irinotecan administration Allergy to contrast media Patient is co-treated with potent CYP3A4/UGT1A1 (cytochrome P450 3A4/uridine diphosphate glucuronosyltransferase 1A1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and St John's Wort Patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study Patient is under judicial protection (France only)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Prenen, MD

Organizational Affiliation

Universitair Ziekenhuis Leuven

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Philippe Pereira, MD

Organizational Affiliation

SLK Kliniken Heilbronn GmbH

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Julien Taieb, MD

Organizational Affiliation

Hôpital Georges Pompidou Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

KUL

City

Leuven

Country

Belgium

Facility Name

SLK-Kliniken Heilbronn GmbH

City

Heilbronn

Country

Germany

Facility Name

Klinikum Bogenhausen, Städt. Klinikum München GmbH

City

Munich

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

LifePearl-Iri Pharmacokinetic Study

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