Clinical trial NCT02547480: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Colorectal Cancer
mCRC
Keywords: liver
metastatic
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
Collaborators: name: Federation Francophone de Cancerologie Digestive
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2015-09-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 2 days
measure: Time to reach Cmax (Tmax)
timeFrame: 2 days
measure: Area Under the Curve (AUC)
timeFrame: 1 day
Secondary outcomes:
measure: Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment
timeFrame: 1 month
measure: Overall Survival
timeFrame: 12 months
measure: Progression-Free Survival
timeFrame: 12 months
measure: Response rate
timeFrame: 3 months
measure: Technical success - treatment delivery
timeFrame: 1 day
measure: Technical success - total dose delivered
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KUL
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Munich
country: Germany
facility: Klinikum Bogenhausen, Städt. Klinikum München GmbH
Study officials:
affiliation: Universitair Ziekenhuis Leuven
name: Hans Prenen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SLK Kliniken Heilbronn GmbH
name: Philippe Pereira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Georges Pompidou Paris
name: Julien Taieb, MD
role: PRINCIPAL_INVESTIGATOR
References: