LifePearl-Iri Pharmacokinetic Study

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547480
• Other study ID #: T126E2
• Status: Completed
• Phase: N/A
• First received: August 27, 2015
• Last updated: November 23, 2017
• Start date: November 2015
• Est. completion date: September 19, 2017

Study information

• Verified date: November 2017
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 19, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• mCRC
• Metastatic Colorectal Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	KUL	Leuven
Germany	SLK-Kliniken Heilbronn GmbH	Heilbronn
Germany	Klinikum Bogenhausen, Städt. Klinikum München GmbH	Munich

Sponsors (3)

Lead Sponsor	Collaborator
Terumo Europe N.V.	Federation Francophone de Cancerologie Digestive, Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38	2 days
Primary	Time to reach Cmax (Tmax)	Tmax will be estimated directly from concentration-time data	2 days
Primary	Area Under the Curve (AUC)	The trapezoidal rule will be used to calculate the area under the curve over 24 hours	1 day
Secondary	Adverse Events (AE) (grade =3) and Serious AEs related with study treatment up to 30 days post initial treatment		1 month
Secondary	Overall Survival		12 months
Secondary	Progression-Free Survival		12 months
Secondary	Response rate	Response rate (mRECIST criteria) 3 months after the first treatment	3 months
Secondary	Technical success - treatment delivery	Ability to deliver =75% of the planned dose during the first chemoembolization	1 day
Secondary	Technical success - total dose delivered	Sum of all doses delivered during the course of the study	6 weeks