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    Clinical Trial Results:
    FOLFIRI + Erbitux versus alternating FOLFIRI + Erbitux/FOLFOX + Erbitux to patients with RAS wild type metastatic colorectalcancer

    Summary
    EudraCT number
    		 2011-004188-65
    Trial protocol
    		 SE   DK  
    Global end of trial date
    29 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2021
    First version publication date
    15 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KFE 11.17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J. B. Winsløws Vej 4, entrance 140, basement, Odense C, Denmark, 5000
    Public contact
    Ida Coordt Elle, Odense University Hospital, +45 29335922, ida.coordt.elle@rsyd.dk
    Scientific contact
    Per Pfeiffer, Odense University Hospital, +45 26283844, per.pfeiffer@rsyd.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Response rate (RR) estimated by the investigator.
    Protection of trial subjects
    Pre-medication to minimize AEs was administered when appropriate.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 49
    Country: Number of subjects enrolled
    Sweden: 41
    Country: Number of subjects enrolled
    Denmark: 83
    Worldwide total number of subjects
    173
    EEA total number of subjects
    173
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    95
    From 65 to 84 years
    78
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between May 2012 and May 2018, 173 patients with RAS and BRAF wildtype metastatic colorectal cancer were included.

    Pre-assignment
    Screening details
    		 RAS and BRAF wildtype mCRC, non-resectable mCRC, 1st line therapy, PS 0-1

    Period 1
    Period 1 title
    Trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FOLFIRI + Cetuximab
    Arm description
    		 FOLFIRI + Cetuximab every two weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m2 i.v. every two weeks.

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m2 i.v.

    Investigational medicinal product name
    5'-fluorouracil
    Investigational medicinal product code
    Other name
    5FU
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    400 mg/m2 i.v. bolus

    Investigational medicinal product name
    5'-fluorouracil
    Investigational medicinal product code
    Other name
    5FU
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2400 mg/m2 i.v. 46 hours.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    180 mg/m2 i.v.

    Arm title
    		 FOLFIRI + Cetuximab/FOLFOX + Cetuximab
    Arm description
    		 Cetuximab every two weeks with alternating FOLFOX/FOLFIRI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m2 i.v. every two weeks.

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m2 i.v.

    Investigational medicinal product name
    5'-fluorouracil
    Investigational medicinal product code
    Other name
    5FU
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    400 mg/m2 i.v. bolus

    Investigational medicinal product name
    5'-fluorouracil
    Investigational medicinal product code
    Other name
    5FU
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2400 mg/m2 i.v. 46 hours.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    180 mg/m2 i.v.

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m2 i.v.

    Number of subjects in period 1
    		FOLFIRI + Cetuximab FOLFIRI + Cetuximab/FOLFOX + Cetuximab
    Started
    86
    87
    Completed
    86
    87

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trial period
    Reporting group description
    		 -

    Reporting group values
    		 Trial period Total
    Number of subjects
    		 173 173
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 95 95
        From 65-84 years
    		 78 78
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 59 59
        Male
    		 114 114

    End points

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    End points reporting groups
    Reporting group title
    FOLFIRI + Cetuximab
    Reporting group description
    		 FOLFIRI + Cetuximab every two weeks.

    Reporting group title
    FOLFIRI + Cetuximab/FOLFOX + Cetuximab
    Reporting group description
    		 Cetuximab every two weeks with alternating FOLFOX/FOLFIRI

    Subject analysis set title
    FOLFIRI + Cetuximab
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients in the active comparator arm.

    Subject analysis set title
    Cetuximab + FOLFOX/FOLFIRI
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients in the experimental arm.

    Primary: Response rate

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    End point title
    		 Response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    60 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see attached poster for additional analyses and information.
    End point values
    		 FOLFIRI + Cetuximab FOLFIRI + Cetuximab/FOLFOX + Cetuximab FOLFIRI + Cetuximab Cetuximab + FOLFOX/FOLFIRI
    Number of subjects analysed
    86
    87
    86
    87
    Units: percent
        number (not applicable)
    11.9
    11.8
    68
    78
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    42 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    FOLFIRI + Cetuximab
    Reporting group description
    		 FOLFIRI + Cetuximab every two weeks.

    Reporting group title
    FOLFIRI + Cetuximab/FOLFOX + Cetuximab
    Reporting group description
    		 Cetuximab every two weeks with alternating FOLFOX/FOLFIRI

    Serious adverse events
    		 FOLFIRI + Cetuximab FOLFIRI + Cetuximab/FOLFOX + Cetuximab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 87 (1.15%)
         number of deaths (all causes)
    86
    87
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 FOLFIRI + Cetuximab FOLFIRI + Cetuximab/FOLFOX + Cetuximab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 86 (100.00%)
    87 / 87 (100.00%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    21 / 86 (24.42%)
    21 / 87 (24.14%)
         occurrences all number
    21
    21
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    25 / 86 (29.07%)
    37 / 87 (42.53%)
         occurrences all number
    25
    37
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    19 / 86 (22.09%)
    23 / 87 (26.44%)
         occurrences all number
    19
    23
    Vomiting
         subjects affected / exposed
    8 / 86 (9.30%)
    7 / 87 (8.05%)
         occurrences all number
    8
    7
    Diarrhoea
         subjects affected / exposed
    22 / 86 (25.58%)
    26 / 87 (29.89%)
         occurrences all number
    22
    26
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    43 / 86 (50.00%)
    50 / 87 (57.47%)
         occurrences all number
    43
    50

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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