NCT01963182

Brief Summary

This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

6.2 years

First QC Date

October 10, 2013

Last Update Submit

December 24, 2019

Conditions

First Line Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan

    during the treatment (an expected average of 7 months)

Secondary Outcomes (2)

  • Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab

    during the first 24 hours of the first cure

  • evaluation of treatment efficacy (progression-free survival, duration of response)

    to progression (1 year)

Study Arms (1)

irinotecan dose based on genetic polymorphism of UGT1A1

EXPERIMENTAL
Drug: Irinotecan

Interventions

IrinotecanDRUG
irinotecan dose based on genetic polymorphism of UGT1A1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal cancer histologically or cytologically proven
  • Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or panitumumab
  • Age\> 18 years
  • Presence of at least one measurable target by RECIST
  • Life expectancy\> 3 months
  • Satisfactory biological functions (renal, hepatic and hematologic)
  • Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the Act of August 9, 2004
  • Patient has signed, after informing the informed consent form

You may not qualify if:

  • Patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing
  • Patient with another pathology deemed incompatible with the entry in the protocol
  • Prior treatment in metastatic
  • Patients taking antiepileptic
  • Allergic reaction or intolerance to irinotecan
  • Heart failure , kidney , bone marrow , liver or respiratory
  • Higher bilirubin 1.5 times the upper limit of normal
  • Significant psychiatric or neurological abnormality
  • Infectious syndrome requiring treatment with antibiotics or antiviral long-term
  • Patients with chronic inflammatory bowel disease and / or bowel obstruction
  • Contraindication Association St. John's wort and yellow fever vaccine
  • Against Heart indication 5-FU
  • Concurrent treatment with a drug test , participation in a clinical trial within \<30 days
  • Patient refused to sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinique de la Châtaigneraie

Beaumont, 63110, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU Estaing

Clermont-Ferrand, 63011, France

Location

Related Publications (1)

  • Ginzac A, Thivat E, Petorin C, Richard D, Herviou P, Molnar I, Devaud H, Creveaux I, Ferrer F, Authier N, Jary M, Pezet D, Durando X. A phase-II study based on dose adjustment according to UGT1A1 polymorphism: is irinotecan underdosed in first-line FOLFIRI regimen for mCRC? Cancer Chemother Pharmacol. 2024 Mar;93(3):225-236. doi: 10.1007/s00280-023-04603-x. Epub 2023 Nov 7.

    PMID: 37932443DERIVED

MeSH Terms

Interventions

Irinotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Hervé DEVAUD, MD

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 16, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 9, 2019

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

FR(3)