Metastatic Colorectal CancerNCT02547480
LifePearl-Iri Pharmacokinetic Study
A study testing TACE with irinotecan loaded LifePearl in people with Metastatic Colorectal Cancer and mCRC, run by Terumo Europe N.V. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, mCRC
- What is being tested?
- TACE with irinotecan loaded LifePearl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2015to 19 Sep 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
SLK-Kliniken Heilbronn GmbH
Heilbronn
Klinikum Bogenhausen, Städt. Klinikum München GmbH
Munich
About this study
Official title: Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan
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
- Being tested
- TACE with irinotecan loaded LifePearl
- Keywords
- liver, metastatic
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE with irinotecan loaded LifePearlDevice
Also called TACE
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.
| Study group | Role | What they receive |
|---|---|---|
| TACE with irinotecan loaded LifePearl | Experimental | 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 Receives: Device: TACE with irinotecan loaded LifePearl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38
Measured: 2 days
Time to reach Cmax (Tmax)
Tmax will be estimated directly from concentration-time data
Measured: 2 days
Area Under the Curve (AUC)
The trapezoidal rule will be used to calculate the area under the curve over 24 hours
Measured: 1 day
Secondary outcomes (6)
Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment
Measured: 1 month
Overall Survival
Measured: 12 months
Progression-Free Survival
Measured: 12 months
Response rate
Response rate (mRECIST criteria) 3 months after the first treatment
Measured: 3 months
Technical success - treatment delivery
Ability to deliver ≥75% of the planned dose during the first chemoembolization
Measured: 1 day
Technical success - total dose delivered
Sum of all doses delivered during the course of the study
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion28 Apr 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federation Francophone de Cancerologie Digestive, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Hans Prenen, MD, Principal investigator, Universitair Ziekenhuis LeuvenPhilippe Pereira, MD, Principal investigator, SLK Kliniken Heilbronn GmbHJulien Taieb, MD, Principal investigator, Hôpital Georges Pompidou Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547480
- Sponsor's protocol ID
- T126E2
- Status last verified
- Nov 2017
- First submitted
- 27 Aug 2015
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes