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    Clinical Trial Results:
    Pre-emptive cycline treatment on Cetuximab-induced skin toxicity in patients with metastatic colorectal cancer treated with an intensified FOLFIRI.

    Summary
    EudraCT number
    		 2010-019140-39
    Trial protocol
    		 FR  
    Global end of trial date
    10 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2021
    First version publication date
    02 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CPP-450
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01317433
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Cancérologie de l'Ouest
    Sponsor organisation address
    15 rue André Boquel, Angers, France, 49055
    Public contact
    Marine TIGREAT, Institut de Cancérologie de l'Ouest, +33 240679878, marine.tigreat@ico.unicancer.fr
    Scientific contact
    Marine TIGREAT, Institut de Cancérologie l'Ouest, +33 240679878, marine.tigreat@ico.unicancer.fr
    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
    10 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    30% decrease in the incidence of acneiform rash type skin toxicity of G >= 2 during preventive treatment with cyclins for 6 weeks. The toxicity is evaluated at each consultation and graded according to the NCI CTCAE v4.0 criteria
    Protection of trial subjects
    In order to ensure the protection of the rights and safety of trial subjects, this clinical trial was performed in compliance with the principles laid down in the declaration of Helsinki, good clinical practice and European regulation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Dec 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    11
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 It must be performed before the start of anticancer treatment with regard to tumor evaluation and pharmacogenetics, at the latest 15 days before randomization for laboratory assessment and within 7 days before randomization for clinical assessment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A : experimental
    Arm description
    		 Intensified FOLFIRI plus Cetuximab + Doxycycline + skin moisturizers, sun protection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DOXYCYCLINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg daily per os o start 7 days before Cetuximab for 6 weeks

    Arm title
    		 Arm B : control
    Arm description
    		 Intensified FOLFIRI plus Cetuximab + skin moisturizers (Dexeryl), sun protection.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Arm A : experimental Arm B : control
    Started
    13
    12
    Completed
    10
    12
    Not completed
    3
    0
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 25 25
    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)
    		 11 11
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 18 18

    End points

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    End points reporting groups
    Reporting group title
    Arm A : experimental
    Reporting group description
    		 Intensified FOLFIRI plus Cetuximab + Doxycycline + skin moisturizers, sun protection.

    Reporting group title
    Arm B : control
    Reporting group description
    		 Intensified FOLFIRI plus Cetuximab + skin moisturizers (Dexeryl), sun protection.

    Primary: Patient with at least grade > or = 2 acne-like skin rash

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    End point title
    		 Patient with at least grade > or = 2 acne-like skin rash
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks of pre-emptive cycline treatment
    End point values
    		 Arm A : experimental Arm B : control
    Number of subjects analysed
    13
    12
    Units: patients
    1
    5
    Statistical analysis title
    		 Efficacy results
    Comparison groups
    Arm A : experimental v Arm B : control
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
    Notes
    [1] - Descriptive

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Adverse event reporting additional description
    Only cutaneous toxicities have been reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC AE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 13 (38.46%)
    3 / 12 (25.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Inferior vena cava syndrome
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Myocardial infarction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    12 / 12 (100.00%)
    Cardiac disorders
    Cheilitis
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Rash erythematous
         subjects affected / exposed
    3 / 13 (23.08%)
    5 / 12 (41.67%)
         occurrences all number
    1
    1
    Rash papulosquamous
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 12 (16.67%)
         occurrences all number
    1
    1
    finger fissur
         subjects affected / exposed
    6 / 13 (46.15%)
    6 / 12 (50.00%)
         occurrences all number
    1
    1
    Paronychia
         subjects affected / exposed
    1 / 13 (7.69%)
    5 / 12 (41.67%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    6 / 13 (46.15%)
    10 / 12 (83.33%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 12 (16.67%)
         occurrences all number
    1
    1
    follicular
         subjects affected / exposed
    5 / 13 (38.46%)
    6 / 12 (50.00%)
         occurrences all number
    1
    1
    palmar-plantar erythrodysesthesia
         subjects affected / exposed
    4 / 13 (30.77%)
    4 / 12 (33.33%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2011
    - increase the number of patients - create a specific consent for screening of DPD - update list of investigators
    31 Jan 2011
    Use a masterful preparation instead of dexeryl - update of the inclusion procedure - specify the deadline for inclusion
    27 Nov 2012
    all metastatic line can be included - prolongation of inclusions

    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.
    The study was terminated prematurely due to a lack of inclusion The logistical burden of this study and the many competing trials did not allow us to recruit the expected number of patients The statistical analysis carried out was only descriptive
    For support, Contact us.
    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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