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    Clinical Trial Results:
    Phase II trial of Cetuximab in combination with chemotherapy (Carboplatinum and Navelbine) for patients with platinum-resistant head- and neckcancer

    Summary
    EudraCT number
    		 2009-013878-40
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jun 2012

    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
    09.08
    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. Winsløvs 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
    15 Jun 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to find a new effective second line treatment regimen for patients with locally advanced or metastatic head- and neck-cancer, who progressed during or after first-line treatment with cisplatinum. Primary objective(s): Response rate (RR) and progression-free survival (PFS)
    Protection of trial subjects
    Pre-medication administered to minimize nausea.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jan 2010
    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: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment for 24 months (01.01.2010-31.12.2011)

    Pre-assignment
    Screening details
    		 Patients with histologically confirmed head- and neck-cancer, where curatively intended treatment is not possible.

    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, Carboplatin, and Vinorelbine .
    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. day 1 every other week.

    Investigational medicinal product name
    Carboplatin
    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
    AUC = 2.4 i.v. on day 1 every other week.

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/m2 i.v. on day 1 every other week.

    Number of subjects in period 1
    		Experimental
    Started
    5
    Completed
    5

    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
    		 5 5
    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)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 4 4
    Subject analysis sets

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

    Subject analysis sets values
    		 Patients
    Number of subjects
    5
    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)
    5
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    1
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Cetuximab, Carboplatin, and Vinorelbine .

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

    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: It makes no sense to perform a statistical analysis on a study of only five patients. The study ended because not enough patients could be recruited.
    End point values
    		 Experimental Patients
    Number of subjects analysed
    5
    5
    Units: months
        median (confidence interval 95%)
    2 (1 to 9)
    2 (1 to 9)
    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
    2 / 5 (40.00%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Allergic reaction to excipient
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abscess oral
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
         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
    5 / 5 (100.00%)
    General disorders and administration site conditions
    Nail disorder
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1

    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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