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    Clinical Trial Results:
    Phase I/II study of Taxotere® (docetaxel), Eloxatin® (oxaliplatin) and Xeloda® (capecitabine) as first line treatment to patients with non-resectable ventricular cancer and/or distal esophageal cancer

    Summary
    EudraCT number
    		 2006-002270-21
    Trial protocol
    		 DK  
    Global end of trial date
    10 Sep 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    05.09
    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
    26 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I: To determine max. tolerable dose (MTD) for the combination regime docetaxel, oxaliplatin and capecitabine (TEX) as first line treatment to patients with primary or recurrent non-resectable cancer of the stomach Phase II: To estimate response rate for treatment with TEX as first line treatment to patients with primary or recurrent non-resectable cancer of the stomach
    Protection of trial subjects
    Pre-medication administered to minimize nausea. Blood tests before start and before each treatment cycle.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2007
    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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    18
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were required to have histologically confirmed adenocarcinoma of the lower oesophagus, gastro-oesophageal junction or stomach not amenable to surgical resection.

    Pre-assignment
    Screening details
    		 From June 2007 to April 2009 23 consecutive patients from two Danish oncology centres were enrolled in this phase I trial. Data was updated December 2009.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose level 1
    Arm description
    		 Docetaxel (T) mg/m2: 60 Oxaliplatin (E) mg/m2: 85 Capecitabine (X): mg/m2/day: 500 x 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose level 1-3: 60 mg/m2 Dose level 4-5: 75 mg/m2

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Eloxatin
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Dose level 1: 85 mg/m2 Dose level 2: 100 mg/m2 Dose level 3: 115 mg/m2 Dose level 4: 115 mg/m2 Dose level 5: 130 mg/m2

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose level 1: 500 mg/m2/day Dose level 2: 625 mg/m2/day Dose level 3-5: 625 mg/m2/day

    Arm title
    		 Dose level 2
    Arm description
    		 Docetaxel (T) mg/m2: 60 Oxaliplatin (E) mg/m2: 100 Capecitabine (X): mg/m2/day: 625 x 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose level 1-3: 60 mg/m2 Dose level 4-5: 75 mg/m2

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Eloxatin
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Dose level 1: 85 mg/m2 Dose level 2: 100 mg/m2 Dose level 3: 115 mg/m2 Dose level 4: 115 mg/m2 Dose level 5: 130 mg/m2

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose level 1: 500 mg/m2/day Dose level 2: 625 mg/m2/day Dose level 3-5: 625 mg/m2/day

    Arm title
    		 Dose level 3
    Arm description
    		 Docetaxel (T) mg/m2: 60 Oxaliplatin (E) mg/m2: 115 Capecitabine (X): mg/m2/day: 625 x 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose level 1-3: 60 mg/m2 Dose level 4-5: 75 mg/m2

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Eloxatin
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Dose level 1: 85 mg/m2 Dose level 2: 100 mg/m2 Dose level 3: 115 mg/m2 Dose level 4: 115 mg/m2 Dose level 5: 130 mg/m2

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose level 1: 500 mg/m2/day Dose level 2: 625 mg/m2/day Dose level 3-5: 625 mg/m2/day

    Arm title
    		 Dose level 4
    Arm description
    		 Docetaxel (T) mg/m2: 75 Oxaliplatin (E) mg/m2: 115 Capecitabine (X): mg/m2/day: 625 x 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose level 1-3: 60 mg/m2 Dose level 4-5: 75 mg/m2

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Eloxatin
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Dose level 1: 85 mg/m2 Dose level 2: 100 mg/m2 Dose level 3: 115 mg/m2 Dose level 4: 115 mg/m2 Dose level 5: 130 mg/m2

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose level 1: 500 mg/m2/day Dose level 2: 625 mg/m2/day Dose level 3-5: 625 mg/m2/day

    Arm title
    		 Dose level 5
    Arm description
    		 Docetaxel (T) mg/m2: 75 Oxaliplatin (E) mg/m2: 130 Capecitabine (X): mg/m2/day: 625 x 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose level 1-3: 60 mg/m2 Dose level 4-5: 75 mg/m2

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Eloxatin
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Dose level 1: 85 mg/m2 Dose level 2: 100 mg/m2 Dose level 3: 115 mg/m2 Dose level 4: 115 mg/m2 Dose level 5: 130 mg/m2

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose level 1: 500 mg/m2/day Dose level 2: 625 mg/m2/day Dose level 3-5: 625 mg/m2/day

    Number of subjects in period 1
    		Dose level 1 Dose level 2 Dose level 3 Dose level 4 Dose level 5
    Started
    3
    3
    3
    10
    4
    Completed
    3
    3
    3
    3
    1
    Not completed
    0
    0
    0
    7
    3
         Physician decision
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    -
    4
    2
         deterioation of health
    -
    -
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 1
    Reporting group description
    		 -

    Reporting group values
    		 Phase 1 Total
    Number of subjects
    		 23 23
    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)
    		 18 18
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    Dose level 1
    Reporting group description
    		 Docetaxel (T) mg/m2: 60 Oxaliplatin (E) mg/m2: 85 Capecitabine (X): mg/m2/day: 500 x 2

    Reporting group title
    Dose level 2
    Reporting group description
    		 Docetaxel (T) mg/m2: 60 Oxaliplatin (E) mg/m2: 100 Capecitabine (X): mg/m2/day: 625 x 2

    Reporting group title
    Dose level 3
    Reporting group description
    		 Docetaxel (T) mg/m2: 60 Oxaliplatin (E) mg/m2: 115 Capecitabine (X): mg/m2/day: 625 x 2

    Reporting group title
    Dose level 4
    Reporting group description
    		 Docetaxel (T) mg/m2: 75 Oxaliplatin (E) mg/m2: 115 Capecitabine (X): mg/m2/day: 625 x 2

    Reporting group title
    Dose level 5
    Reporting group description
    		 Docetaxel (T) mg/m2: 75 Oxaliplatin (E) mg/m2: 130 Capecitabine (X): mg/m2/day: 625 x 2

    Primary: Patients without DLT

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    End point title
    		 Patients without DLT [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    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: The end point of the trial was to establish recommended doses for the TEX regimen. This is done by counting the number of patients that experience dose limiting toxicities at various dose levels. Dose levels and number of patients, who did not experience DLTs have been noted. See also publication.
    End point values
    		 Dose level 1 Dose level 2 Dose level 3 Dose level 4 Dose level 5
    Number of subjects analysed
    3
    3
    3
    10
    4
    Units: patients
    3
    3
    3
    9
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Three months.
    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
    1 / 23 (4.35%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 23 (100.00%)
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    12 / 23 (52.17%)
         occurrences all number
    12
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    19 / 23 (82.61%)
         occurrences all number
    19
    Thrombocytopenia
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    14 / 23 (60.87%)
         occurrences all number
    14
    Nail toxicity
         subjects affected / exposed
    14 / 23 (60.87%)
         occurrences all number
    14
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 23 (39.13%)
         occurrences all number
    9
    Diarrhoea
         subjects affected / exposed
    12 / 23 (52.17%)
         occurrences all number
    12
    Vomiting
         subjects affected / exposed
    9 / 23 (39.13%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Oct 2008
    3 patients have been treated at dose level I-IV (total 12 patients) and 4 patients have been treated at dose level V. 2 patients experienced DLT and additional 2 patients had a symptomatic neutrophenia which required dose reduction in subsequent courses. MTD was reached at dose level V. To ensure tolerability of dose level IV we will include additional 6 patients at dose level IV as this is standard practice in most fase I studies. If 2 or more of the 6 new patients experience DLT, 6 additional patients will be treated at dose level III. Unfortunately this was not written in the original protocol.
    28 May 2010
    A small dose reduction to: Taxotere 51 mg/m2 day 1 (reduced from 60 mg) Oxaliplatin 100 mg/m2 day 1 (reduced from 115 mg) Capecitabin 625 mg/m2 twice a day continuously

    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/20843172
    http://www.ncbi.nlm.nih.gov/pubmed/20429725
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