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    Clinical Trial Results:
    Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum resistant esofagus- or gastric cancer

    Summary
    EudraCT number
    		 2008-006168-12
    Trial protocol
    		 DK  
    Global end of trial date
    25 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2021
    First version publication date
    19 Mar 2021
    Other versions
    Summary report(s)
    		 SAE list

    Trial information

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    Trial identification
    Sponsor protocol code
    08.14
    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
    03 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objektives are responserate and time to progression.
    Protection of trial subjects
    Administration of pre-medication to minimize adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2009
    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: 71
    Worldwide total number of subjects
    71
    EEA total number of subjects
    71
    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
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Jan. 2009-Feb. 2013

    Pre-assignment
    Screening details
    		 Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum-resistent esophagus- or stomach-cancer. Patients with either adenocarcinoma or planocellular carcinoma can be included in the trial.

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

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Cetuximab+Irinotecan
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m2 i.v. on day 1 every two weeks.

    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. on day 1 every two weeks.

    Number of subjects in period 1
    		Experimental
    Started
    71
    Completed
    71

    Baseline characteristics

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

    Reporting group values
    		 Trial Total
    Number of subjects
    		 71 71
    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
    		 31 31
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 56 56
    Subject analysis sets

    Subject analysis set title
    Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis of all patients included in Odense.

    Subject analysis sets values
    		 Patients
    Number of subjects
    71
    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
    31
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    56

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Cetuximab+Irinotecan

    Subject analysis set title
    Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis of all patients included in Odense.

    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: No statistical analysis has been performed on the 71 patients from Odense. Analysis of 63 patients included in Odense and Aalborg has been performed in the attached publication.
    End point values
    		 Experimental Patients
    Number of subjects analysed
    71
    71
    Units: months
        median (confidence interval 95%)
    2.8 (1.8 to 3.5)
    2.8 (1.8 to 3.5)
    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.
    Adverse event reporting additional description
    Please refer to the attached SAE list (attached as Summary) and publication.
    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
    6 / 71 (8.45%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    6
    Cardiac disorders
    Ischaemia
    Additional description: Visceral arterial ischemia.
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Nervous system disorders
    Cerebral vascular occlusion
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Ileus
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Pseudomonas infection
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    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
    20 / 71 (28.17%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 71 (12.68%)
         occurrences all number
    15
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 71 (11.27%)
         occurrences all number
    8
    Nausea
         subjects affected / exposed
    3 / 71 (4.23%)
         occurrences all number
    6

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22244801
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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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