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LifePearl-Iri Pharmacokinetic Study

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ClinicalTrials.gov Identifier: NCT02547480
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : November 27, 2017
Sponsor:
Collaborators:
Federation Francophone de Cancerologie Digestive
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Terumo Europe N.V.

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer mCRC Device: TACE with irinotecan loaded LifePearl Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan
Study Start Date : November 2015
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : September 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.
Other Name: TACE




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 2 days ]
    Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38

  2. Time to reach Cmax (Tmax) [ Time Frame: 2 days ]
    Tmax will be estimated directly from concentration-time data

  3. Area Under the Curve (AUC) [ Time Frame: 1 day ]
    The trapezoidal rule will be used to calculate the area under the curve over 24 hours


Secondary Outcome Measures :
  1. Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment [ Time Frame: 1 month ]
  2. Overall Survival [ Time Frame: 12 months ]
  3. Progression-Free Survival [ Time Frame: 12 months ]
  4. Response rate [ Time Frame: 3 months ]
    Response rate (mRECIST criteria) 3 months after the first treatment

  5. Technical success - treatment delivery [ Time Frame: 1 day ]
    Ability to deliver ≥75% of the planned dose during the first chemoembolization

  6. Technical success - total dose delivered [ Time Frame: 6 weeks ]
    Sum of all doses delivered during the course of the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547480


Locations
Belgium
KUL
Leuven, Belgium
Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
Klinikum Bogenhausen, Städt. Klinikum München GmbH
Munich, Germany
Sponsors and Collaborators
Terumo Europe N.V.
Federation Francophone de Cancerologie Digestive
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Hans Prenen, MD Universitair Ziekenhuis Leuven
Principal Investigator: Philippe Pereira, MD SLK Kliniken Heilbronn
Principal Investigator: Julien Taieb, MD Hôpital Georges Pompidou Paris

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT02547480     History of Changes
Other Study ID Numbers: T126E2
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by Terumo Europe N.V.:
liver
metastatic

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action