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    Clinical Trial Results:
    Phase II study with cetuximab, irinotecan and sunitinib (CIS) for patients with treatment resistant colorectal cancer.

    Summary
    EudraCT number
    2007-004232-22
    Trial protocol
    DK  
    Global end of trial date
    07 May 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Mar 2021
    First version publication date
    18 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SIC
    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 2, 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
    01 Jun 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the combination of Cetuximab, Irinotecan and Sunitinib (CIS or SIC) for treatment of patients with treatment-resistant colorectal cancer.
    Protection of trial subjects
    Administration of pre-medication to minimize adverse reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Jan 2008
    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
    Denmark: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    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)
    40
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    November 2007-January 2009. Follow-up until disease progression. Expected number of patients: 55.

    Pre-assignment
    Screening details
    In Denmark, approximately 150 patients per year will be of adequate performance status to be offered 3rd line chemotherapy. Before the introduction of Cetuximab and Irinotecan, there was no 3rd line treatment to offer these patients. Adding Sunitinib to the regimen is expected to prolong PFS and thereby quality of life for these patients.

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

    Arms
    Arm title
    Experimental
    Arm description
    Cetuximab 500 mg/m² i.v. day 1 every 2 weeks. Irinotecan 180 mg/m² i.v. day 1 every 2 weeks. Sunitinib 25 mg p.o. daily for 4 weeks and afterwards 37.5 mg daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m2 on day 1 every two weeks.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    180 mg/m2 on day 1 every two weeks.

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Sutent
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg per day for 4 weeks and then 37.5 mg per day.

    Number of subjects in period 1
    Experimental
    Started
    55
    Completed
    55

    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
    55 55
    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)
    40 40
        From 65-84 years
    15 15
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Male
    30 30
        Female
    25 25
    Subject analysis sets

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients in the study.

    Subject analysis sets values
    Patients
    Number of subjects
    55
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    40
        From 65-84 years
    15
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Male
    30
        Female
    25

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    Cetuximab 500 mg/m² i.v. day 1 every 2 weeks. Irinotecan 180 mg/m² i.v. day 1 every 2 weeks. Sunitinib 25 mg p.o. daily for 4 weeks and afterwards 37.5 mg daily.

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients in the study.

    Primary: Progression-free survival

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    End point title
    Progression-free survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 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: The study was not deemed publishable; therefore no thurough analysis of the data was performed.
    End point values
    Experimental Patients
    Number of subjects analysed
    20
    20
    Units: months
        median (confidence interval 95%)
    3 (0 to 8)
    3 (0 to 8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Last treatment+30 days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Patients
    Reporting group description
    -

    Serious adverse events
    Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 55 (36.36%)
         number of deaths (all causes)
    19
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombosis
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Febrile neutropenia
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile infection
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 55 (81.82%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    40 / 55 (72.73%)
         occurrences all number
    40
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    18 / 55 (32.73%)
         occurrences all number
    18
    Nausea
         subjects affected / exposed
    20 / 55 (36.36%)
         occurrences all number
    24

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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