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    Clinical Trial Results:
    Dose determination of Taxotere®, Eloxatin® and Xeloda® (TEX) in combination with Herpectin® as first line treatment to patients with HER2-positive non-resectable esophagus, cardia or gastric cancer

    Summary
    EudraCT number
    		 2010-021016-41
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jun 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    10.05
    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
    03 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine maximum tolerable dose (MTD) for the combination regime TEX (docetaxel, oxaliplatin and capecitabine) + trastuzumab and to evaluate the toxicity
    Protection of trial subjects
    Administration of pre-medication to minimize adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Mar 2011
    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: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    10
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 March 2011-November 2014.

    Pre-assignment
    Screening details
    		 Patients with histologically confirmed ECV adenocarcinoma, non-resectable or metastatic disease. Tumor tissue must be HER2 positive.

    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
    		 Six treatments with Her-TEX followed by Trastuzumab monotherapy until disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab
    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
    8 mg/kg i.v. over 90 minutes on day 1, hereafter 6 mg/kg i.v. over 30 minutes every three weeks.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 42-60 mg/kg (70-100% dose) i.v. over 60 minutes on day 1 every three weeks.

    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
    Oxaliplatin 100 mg/m2 i.v. over 30 minutes on day 1 every three weeks.

    Investigational medicinal product name
    Capecitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    625 mg/m2/day twice a day (1250 mg/m2 daily) continuously.

    Number of subjects in period 1
    		Experimental
    Started
    17
    Completed
    17

    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
    		 17 17
    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)
    		 10 10
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 12 12
    Subject analysis sets

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

    Subject analysis sets values
    		 Patients
    Number of subjects
    17
    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)
    10
        From 65-84 years
    7
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    12

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Six treatments with Her-TEX followed by Trastuzumab monotherapy until disease progression.

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

    Primary: Dose establishment

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    End point title
    		 Dose establishment [1]
    End point description
    Dose level escalation of Docetaxel: 42 - 60 mg/m2. Dose level 3 was never included. Dose level 2 is the maximal tolerable dose.
    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 this type of end point. It is based on doctors' evaluation of MTD.
    End point values
    		 Experimental Patients
    Number of subjects analysed
    17
    17
    Units: dose level
    2
    2
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Five patients did not progress during the five year time frame. Four are still alive as of March 2021.
    End point type
    Secondary
    End point timeframe
    60 months
    End point values
    		 Experimental Patients
    Number of subjects analysed
    17
    17
    Units: months
        median (confidence interval 95%)
    10 (3 to 60)
    10 (3 to 60)
    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
    13 / 17 (76.47%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Edema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Febrile infection
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 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
    17 / 17 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    5
    Nail toxicity
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    7

    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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