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    Clinical Trial Results:
    Bi-weekly Cetuximab combined with FOLFOX-6 as first-line treatment in metastatic colorectal cancer patients with wild-type k-ras status

    Summary
    EudraCT number
    		 2007-000460-24
    Trial protocol
    		 DE  
    Global end of trial date
    23 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2020
    First version publication date
    13 Mar 2020
    Other versions
    Summary report(s)
    		 SynpsosisCSR__2007-000460-24

    Trial information

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    Trial identification
    Sponsor protocol code
    TT1-2007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01051167
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Duisburg-Essen
    Sponsor organisation address
    Hufelandstraße 55, Essen, Germany, 45122
    Public contact
    Prof. Dr. med. Martin Schuler, University of Duisburg-Essen, +49 (0)201 723-20 00, martin.schuler@uk-essen.de
    Scientific contact
    Prof. Dr. med. Martin Schuler, University of Duisburg-Essen, +49 (0)201 723-20 00, martin.schuler@uk-essen.de
    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
    20 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Response rate (using RECIST-Criteria vs 1.0)
    Protection of trial subjects
    The treatment should be conducted exactly as described in the protocol. Any protocol deviation were reported. The recommendations of Good Clinical Practice (see ICH-GCP: International Conference on Harmonisation - Good Clinical Practice), valid since 17 January 1997, were met.
    Background therapy
    		 Sedatives, antibiotics, analgesics, antihistamines, steroids, granulocyte-colony stimulating factor, erythropoetin, or other medications as well as red blood cells, platelets or fresh frozen plasma transfusions could be given to assist in the management of pain, infection, and other complications of the malignancy. Patients had to be pre-medicated with an antihistamine and corticosteroid before receiving the first three infusions of cetuximab. Premedication with an antihistamine and corticosteroid before subsequent infusions was recommended. Patients could be pre-medicated before oxaliplatin infusions according to local standard routine
    Evidence for comparator
    		 Since this was a single arm trial, no comparators were used.
    Actual start date of recruitment
    14 Aug 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 36 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    36
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Upon obtaining signed informed consent, screening evaluations were performed to confirm eligibility and to obtain baseline safety data. Between 14-Aug-2009 (First patient in) and 21-Nov-2013 (Last patient in) 60 patients were registered by 6 sites ( medical practices as well as hospitals) in Germany.

    Pre-assignment
    Screening details
    		 The selection of patients occurred through the investigator according to the inclusion and exclusion criteria after having informed the patient in writing and orally about the study and after the patient has signed the informed consent. These baseline examinations should be performed within 3 weeks before start of treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 57
    Number of subjects completed
    		 57

    Period 1
    Period 1 title
    Start of therapy (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cetuximab + Folfox-6
    Arm description
    		 Biweekly Cetuximab in combination with a biweekly FOLFOX 6 regimen
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Erbitux
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    After registration into the clinical trial patients received cetuximab 500 mg/m² as an intravenous infusion on day 1 every 2 weeks. Infusion time was 120 minutes for the first treatment and was reduced to 90 minutes for the second infusion and to 60 minutes for subsequent infusions.

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg oxaliplatin /m² body surface area was given as i.v. infusion for 2 hours every 2 weeks

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg folinic acid/m² was given as intravenous infusion over 120 minutes concurrently with oxaliplatin, d1, q14d

    Investigational medicinal product name
    5-Fluorouracil (5-FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg 5 - Fluoruracil /m² iv was given as bolus after Folinic Acid, d1, q14d After bolus infusion, 2400 mg/m² 5-FU was applied as iv infusion over 46 h, d1, q14d

    Number of subjects in period 1
    		Cetuximab + Folfox-6
    Started
    57
    Completed
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Start of therapy
    Reporting group description
    		 -

    Reporting group values
    		 Start of therapy Total
    Number of subjects
    		 57 57
    Age categorical
    Male and female patients ≥ 18 years of age could be registered. There was no naximum age limit. Age of patients was calculated by subtracting year of birth from year of enrolment.
    Units: Subjects
        <30 years
    		 2 2
        30-40 years
    		 1 1
        41-50 years
    		 8 8
        51-60 years
    		 17 17
        61-70 years
    		 17 17
        71-80 years
    		 12 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 1.67 ) -
    Gender categorical
    There was no preferred enrolment of men or women within this study. However, pregnant or breast-feeding women were excluded from participation.
    Units: Subjects
        Female
    		 21 21
        Male
    		 36 36
    Subject analysis sets

    Subject analysis set title
    ITT set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Received at least 1 administration of cetuximab

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    received at least 1 cycle of study medication

    Subject analysis set title
    PP set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Received at least 5 cycles of study therapy

    Subject analysis sets values
    		 ITT set Safety set PP set
    Number of subjects
    57
    56
    50
    Age categorical
    Male and female patients ≥ 18 years of age could be registered. There was no naximum age limit. Age of patients was calculated by subtracting year of birth from year of enrolment.
    Units: Subjects
        <30 years
    2
    2
    2
        30-40 years
    1
    1
    1
        41-50 years
    8
    8
    7
        51-60 years
    17
    17
    14
        61-70 years
    17
    17
    16
        71-80 years
    12
    11
    10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60 ( 1.67 )
    59.7 ( 1.67 )
    59.8 ( 1.8 )
    Gender categorical
    There was no preferred enrolment of men or women within this study. However, pregnant or breast-feeding women were excluded from participation.
    Units: Subjects
        Female
    21
    21
    19
        Male
    36
    35
    31

    End points

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    End points reporting groups
    Reporting group title
    Cetuximab + Folfox-6
    Reporting group description
    		 Biweekly Cetuximab in combination with a biweekly FOLFOX 6 regimen

    Subject analysis set title
    ITT set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Received at least 1 administration of cetuximab

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    received at least 1 cycle of study medication

    Subject analysis set title
    PP set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Received at least 5 cycles of study therapy

    Primary: Objective response rate (ORR) according to RECIST criteria

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    End point title
    		 Objective response rate (ORR) according to RECIST criteria [1]
    End point description
    The primary target value of this study was the objective response rate, using RECIST criteria. Each set of tumor responses was assessed to determine the best overall response. ORR was defined by number of patients with CR+PR as best response.
    End point type
    Primary
    End point timeframe
    Tumor assessment was perforemd at baseline and every 8 weeks during during study therapy; after last study treatment administration tumor asessment was performed every 3 months until end of follow-up.
    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: Simon Two-Stage desgin. Altogether 37 patients of the ITT set had CR or PR as best response; this amounted to an ORR of 65%. DCR (CR+PR+SD) was 84.1%. In the first stage 25 responders and in the second stage 35 responders were observed, which was more than the necessary number (≥13 responders in the first stage and ≥25 responders after completion of the second stage) to reject the null hypothesis H0: p ≤ 0.35.
    End point values
    		 Cetuximab + Folfox-6 ITT set Safety set PP set
    Number of subjects analysed
    57
    57
    56
    50
    Units: number of patients
        Complete remission (CR)
    1
    1
    1
    1
        Partial response (PR)
    36
    36
    36
    35
        Stable disease (SD)
    11
    11
    11
    9
        Progressive disease (PD)
    5
    5
    5
    3
        Not evaluated
    4
    4
    3
    2
        ORR (CR+PR)
    37
    37
    37
    36
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    Patients with documented objective response, namely CR and PR, were included into this calculation.
    End point type
    Secondary
    End point timeframe
    For this analysis patients were censored at time point of metastasectomy or loss to follow up.
    End point values
    		 Cetuximab + Folfox-6 ITT set Safety set PP set
    Number of subjects analysed
    37
    37
    37
    36
    Units: months
        median (confidence interval 95%)
    10.28 (4.18 to 16.39)
    10.28 (4.18 to 16.39)
    10.28 (4.18 to 16.39)
    10.28 (4.18 to 16.39)
    No statistical analyses for this end point

    Secondary: Metastasectomy rate

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    End point title
    		 Metastasectomy rate
    End point description
    Proportions of patients who were able to undergo complete metastasectomy after study treatment
    End point type
    Secondary
    End point timeframe
    From start of therapy until end of study treatment
    End point values
    		 Cetuximab + Folfox-6 ITT set Safety set PP set
    Number of subjects analysed
    57
    57
    56
    50
    Units: number of patients
    19
    19
    19
    18
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    Progression free survival of a patient was defined as the time in months from registration until PD is observed or death occurs due to any cause within 90 days after the last tumor assessment or registration. Patients not known to progress or die were censored at their date of last contact or 90 days after the last tumor assessment or registration, whichever came first.
    End point type
    Secondary
    End point timeframe
    From registration until observed PD or death due to any cause within 90 days after the last tumor assessment or registration
    End point values
    		 Cetuximab + Folfox-6 ITT set Safety set PP set
    Number of subjects analysed
    57
    57
    56
    50
    Units: months
        median (confidence interval 95%)
    10.05 (8.33 to 11.775)
    10.05 (8.33 to 11.775)
    10.81 (9.10 to 12.52)
    10.94 (9.39 to 12.49)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    OS (in months) was easured from the date of registration until death occurs due to any cause. OS for subjects not known to die will be censored at their date of last contact.
    End point type
    Secondary
    End point timeframe
    From the date of registration until death occurs due to any cause.
    End point values
    		 Cetuximab + Folfox-6 ITT set Safety set PP set
    Number of subjects analysed
    57
    57
    56
    50
    Units: months
        median (confidence interval 95%)
    28.65 (18.86 to 38.44)
    28.65 (18.86 to 38.44)
    29.37 (17.03 to 41.71)
    29.37 (17.33 to 41.41)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of signing informed consent until end of treatment
    Adverse event reporting additional description
    Toxicities were defined according to the NCI-CTC-Toxicity Criteria version 3.0. Any AE that occured in the course of a clinical study were monitored and followed up until the End of Study Visit. Only AEs of special interest were taken into account.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    ITT set
    Reporting group description
    		 -

    Serious adverse events
    		 ITT set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 57 (33.33%)
         number of deaths (all causes)
    36
         number of deaths resulting from adverse events
    1
    Injury, poisoning and procedural complications
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Chills
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Stricture/stenosis GI - Colon sigmoideum
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rosacea
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Urinary tract obstruction
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 ITT set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 57 (100.00%)
    Investigations
    Lipase
         subjects affected / exposed
    8 / 57 (14.04%)
         occurrences all number
    12
    Amylase
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    6
    Nervous system disorders
    Peripheral sensory neuropathy/Nervous system disorder
         subjects affected / exposed
    31 / 57 (54.39%)
         occurrences all number
    51
    Peripheral motor neuropathy
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    5
    Platelet count decreased
         subjects affected / exposed
    14 / 57 (24.56%)
         occurrences all number
    34
    White blood cell count decreased
         subjects affected / exposed
    17 / 57 (29.82%)
         occurrences all number
    22
    Granulocytes count decreased
         subjects affected / exposed
    18 / 57 (31.58%)
         occurrences all number
    31
    Haemoglobin (Anemia)
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    14
    General disorders and administration site conditions
    Adverse drug reaction/Hypersensitivity
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    7
    Chills/Pyrexia
         subjects affected / exposed
    7 / 57 (12.28%)
         occurrences all number
    9
    Cytokine release syndrome
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Eyelid disorder
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Uveitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    9
    Diarrhoea
         subjects affected / exposed
    24 / 57 (42.11%)
         occurrences all number
    32
    Nausea/Malaise
         subjects affected / exposed
    28 / 57 (49.12%)
         occurrences all number
    56
    Vomiting
         subjects affected / exposed
    8 / 57 (14.04%)
         occurrences all number
    11
    Stomatitis/Oesophagitis
         subjects affected / exposed
    15 / 57 (26.32%)
         occurrences all number
    19
    Hepatobiliary disorders
    Transaminases abnormal
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    7
    Blood alkaline phosphatase
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    35 / 57 (61.40%)
         occurrences all number
    53
    Dry skin
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Eczema
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    rash (Exfoliative, maculo-papular)/Folliculitis
         subjects affected / exposed
    23 / 57 (40.35%)
         occurrences all number
    32
    Skin disorder/ haemorrhage/ hyperpigmentation
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    14
    Skin fissures
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Nail bed inflammation/nail disorder
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    10 / 57 (17.54%)
         occurrences all number
    15
    Pruritus
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Infections and infestations
    Febrile infection
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Infection
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Neutropenic infection
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Appetite lost
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Cachexia
         subjects affected / exposed
    7 / 57 (12.28%)
         occurrences all number
    9
    Weight decreased
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Apr 2009
    Change in time points of blood sampling for translational project Change in patient's questionnaires
    10 Feb 2010
    Prolongation of recruiting period Change in time points of blood sampling for translational research project (at baseline and at administration of second study treatment cycle No central K-RAS assessment
    09 Jun 2010
    Chamge of exclusion criteria
    27 Dec 2011
    Change of sponsor representative and coordinationg investigator

    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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