LifePearl-Iri Pharmacokinetic Study

NCT ID: NCT02547480

Last Updated: 2017-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-09-19

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.

Conditions

Metastatic Colorectal Cancer; mCRC

Keywords

liver; metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE with irinotecan loaded LifePearl

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

Group Type: EXPERIMENTAL

TACE with irinotecan loaded LifePearl

Intervention Type: DEVICE

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.

Interventions

TACE with irinotecan loaded LifePearl

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.

Intervention Type: DEVICE

Other Intervention Names

TACE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Terumo Europe N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Prenen, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Leuven

Philippe Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

SLK Kliniken Heilbronn GmbH

Julien Taieb, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Georges Pompidou Paris

Locations

KUL

Leuven, , Belgium

SLK-Kliniken Heilbronn GmbH

Heilbronn, , Germany

Klinikum Bogenhausen, Städt. Klinikum München GmbH

Munich, , Germany

Countries

Belgium; Germany

Other Identifiers

T126E2

Identifier Type: -

Identifier Source: org_study_id