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    Clinical Trial Results:
    A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients

    Summary
    EudraCT number
    		 2006-000441-19
    Trial protocol
    		 DE   ES   IT  
    Global end of trial date
    27 Aug 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2016
    First version publication date
    15 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H3E-EW-S098
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00325234
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: H3E-EW-S098, Trial ID: 10826
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM, Eli Lilly and Company, 1 800-877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM, Eli Lilly and Company, 1 800-285-4559,
    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
    27 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to help answer the following research questions: •whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long •to learn more about the side effects in each chemotherapy combination treatment arm •to assess how participants with advanced breast cancer report health changes while receiving any of the chemotherapy combination arm
    Protection of trial subjects
    This study was conducted in accordance with International Code of Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jun 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Italy: 30
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    Switzerland: 9
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    South Africa: 13
    Worldwide total number of subjects
    135
    EEA total number of subjects
    87
    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)
    115
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not Applicable

    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
    		 Pemetrexed/Carboplatin
    Arm description
    		 Pemetrexed 600 milligram per meter squared (mg/m^2) was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 milligram/minute/millilter (mg*min/mL). The cycle of treatment was 21 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed 600 mg/m^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days until disease progression or unacceptable toxicity.

    Arm title
    		 Gemcitabine/Vinorelbine
    Arm description
    		 Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    LY188011, Gemzar
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1200 mg/m^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

    Number of subjects in period 1
    		Pemetrexed/Carboplatin Gemcitabine/Vinorelbine
    Started
    69
    66
    Received at Least 1 Dose of Study Drug
    65
    66
    Completed
    0
    0
    Not completed
    69
    66
         'Death due to Study Disease '
    1
    -
         Physician decision
    17
    12
         Subject Decision
    6
    8
         Adverse event, non-fatal
    10
    7
         'Progressive Disease '
    34
    37
         Entry Criteria Not Met
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pemetrexed/Carboplatin
    Reporting group description
    		 Pemetrexed 600 milligram per meter squared (mg/m^2) was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 milligram/minute/millilter (mg*min/mL). The cycle of treatment was 21 days

    Reporting group title
    Gemcitabine/Vinorelbine
    Reporting group description
    		 Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.

    Reporting group values
    		 Pemetrexed/Carboplatin Gemcitabine/Vinorelbine Total
    Number of subjects
    		 69 66 135
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.9 ± 11.38 52.3 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    		 69 66 135
        Male
    		 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 67 61 128
        African
    		 1 3 4
        Hispanic
    		 0 1 1
        East Asian
    		 1 0 1
        West Asian
    		 0 1 1
    Region of Enrollment
    Units: Subjects
        Spain
    		 18 18 36
        Switzerland
    		 5 4 9
        Israel
    		 9 9 18
        Germany
    		 9 12 21
        Italy
    		 16 14 30
        Turkey
    		 5 3 8
        South Africa
    		 7 6 13
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    The Eastern Cooperative Oncology Group (ECOG) scales and criteria are used by doctors to assess disease progression, assess the patient’s living ability, and determine prognosis. The scale is as follows: 0-Fully active, able to carry on all pre-disease performance without restriction. 1-Restricted in activity but ambulatory and able to perform sedentary work. 2-Ambulatory but unable to work. Up and about > 50% of waking hours. 3-Capable of only limited selfcare, confined to bed or chair > 50% of waking hours. 4-Completely disabled. Cannot self care. Totally confined to bed or chair. 5-Dead.
    Units: Subjects
        ECOG 0
    		 39 39 78
        ECOG 1
    		 28 27 55
        ECOG 2
    		 2 0 2
    Hormonal Receptor Status
    Hormone receptor status is a positive or negative measure of estrogen (ER) or progesterone (PR) hormone receptors found in cancer cells. In hormone receptor negative tumors, estrogen and/or progesterone are not present in cancer cells. In hormone receptor positive tumors, estrogen and/or progesterone hormone receptors are present in the cancer cells.
    Units: Subjects
        Estrogen and Progesterone Negative
    		 19 21 40
        Estrogen and/or Progesterone Positive
    		 49 44 93
        Unknown
    		 1 1 2
    Human Epidermal Growth Factor Receptor 2 (HER-2/Neu)
    The Human Epidermal Growth Factor Receptor 2 plays an important role in cell growth and development. HER-2/Neu status is determined by an assay. A positive HER-2/Neu result indicates that HER-2 gene receptors are present; negative HER-2/Neu indicates the absence of HER-2 gene receptors.
    Units: Subjects
        Positive
    		 12 13 25
        Negative
    		 53 49 102
        Not Performed
    		 0 1 1
        Unknown
    		 4 3 7
    Tumor Differentiation Grade
    Classification of tumors into one of four grades based upon how similar in appearance the tumor cells are to normal cells, and by how many tumor cells are dividing. The more tumor cells that are dividing, the greater likelihood of tumor growth and the higher the tumor grade. A lower tumor grade is associated with a better prognosis. Grade 1 - Well-Differentiated, Low cell division Grade 2 - Moderately Differentiated, Moderate cell division Grade 3 - Poorly Differentiated, High cell division Grade 4 - Undifferentiated, High cell division
    Units: Subjects
        Grade I
    		 6 3 9
        Grade II
    		 25 27 52
        Grade III
    		 32 30 62
        Unknown
    		 6 6 12
    Pathological Diagnosis
    This measure is the specific diagnosis of breast cancer based upon pathological diagnosis.
    Units: Subjects
        Carcinoma, Ductal, Breast
    		 64 54 118
        Carcinoma, Lobular, Breast
    		 4 5 9
        Carcinoma, Inflammatory, Breast
    		 1 3 4
        Carcinoma, Mixed Cell, Breast
    		 0 1 1
        Other
    		 0 3 3

    End points

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    End points reporting groups
    Reporting group title
    Pemetrexed/Carboplatin
    Reporting group description
    		 Pemetrexed 600 milligram per meter squared (mg/m^2) was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 milligram/minute/millilter (mg*min/mL). The cycle of treatment was 21 days

    Reporting group title
    Gemcitabine/Vinorelbine
    Reporting group description
    		 Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.

    Primary: Tumor Response Rate

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    End point title
    		 Tumor Response Rate [1]
    End point description
    Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.
    End point type
    Primary
    End point timeframe
    Baseline up to 30 days of follow-up after 21 cycles of treatment.
    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: There is no statistical analysis for the primary endpoint of Tumor Response Rate. Descriptive statistics are used to represent the tumor response in each treatment arm and reported as percentage of participants with a 95% confidence interval.
    End point values
    		 Pemetrexed/Carboplatin Gemcitabine/Vinorelbine
    Number of subjects analysed
    64
    61
    Units: Participants
    number (confidence interval 95%)
        Overall Response
    26.6 (16.3 to 39.1)
    29.5 (18.5 to 42.6)
        Complete Response
    0 (0 to 5.6)
    3.3 (0.4 to 11.3)
        Partial Response
    26.6 (16.3 to 39.1)
    26.2 (15.8 to 39.1)
        Stable Disease
    35.9 (24.3 to 48.9)
    34.4 (22.7 to 47.7)
        Progressive Disease
    26.6 (16.3 to 39.1)
    27.9 (17.1 to 40.8)
        Unknown
    10.9 (4.5 to 21.2)
    8.2 (2.7 to 18.1)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.
    End point type
    Secondary
    End point timeframe
    Time of response to progressive disease (up to 19 months) .
    End point values
    		 Pemetrexed/Carboplatin Gemcitabine/Vinorelbine
    Number of subjects analysed
    17
    19
    Units: Months
    median (confidence interval 95%)
        Duration of Response
    7.7 (4.2 to 12.2)
    7.5 (4.9 to 8.3)
    No statistical analyses for this end point

    Secondary: Time to Progressive Disease (PD)

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    End point title
    		 Time to Progressive Disease (PD)
    End point description
    Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.
    End point type
    Secondary
    End point timeframe
    Baseline to measured PD (up to 25.1 months).
    End point values
    		 Pemetrexed/Carboplatin Gemcitabine/Vinorelbine
    Number of subjects analysed
    69
    66
    Units: Months
    median (confidence interval 95%)
        Time to Progressive Disease (PD)
    5.1 (4.1 to 8)
    5.6 (4.2 to 7.5)
    No statistical analyses for this end point

    Secondary: Time To Treatment Failure (TTTF)

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    End point title
    		 Time To Treatment Failure (TTTF)
    End point description
    TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment (up to 21.9 months).
    End point values
    		 Pemetrexed/Carboplatin Gemcitabine/Vinorelbine
    Number of subjects analysed
    69
    66
    Units: Months
    median (confidence interval 95%)
        Time To Treatment Failure (TTTF)
    4.8 (3.3 to 7)
    5.1 (3.5 to 6.3)
    No statistical analyses for this end point

    Secondary: Time to Response

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    End point title
    		 Time to Response
    End point description
    Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.
    End point type
    Secondary
    End point timeframe
    Baseline to response (up to 7.8 months).
    End point values
    		 Pemetrexed/Carboplatin Gemcitabine/Vinorelbine
    Number of subjects analysed
    17
    19
    Units: Months
    median (confidence interval 95%)
        Time to Response
    1.8 (1.6 to 3.3)
    1.8 (1.6 to 3.1)
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events (AE)

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    End point title
    		 Number of Participants With Adverse Events (AE)
    End point description
    A listing of adverse events is presented in the Reported Adverse Event Module.
    End point type
    Secondary
    End point timeframe
    Every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)
    End point values
    		 Pemetrexed/Carboplatin Gemcitabine/Vinorelbine
    Number of subjects analysed
    65
    66
    Units: Participants
    number (not applicable)
        Adverse Events
    64
    66
        Serious Adverse Events
    18
    22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H3E-EW-S098
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Arm B: Vinorelbine plus Gemcitabine
    Reporting group description
    		 -

    Reporting group title
    Arm A: Pemetrexed plus Carboplatin
    Reporting group description
    		 -

    Serious adverse events
    		 Arm B: Vinorelbine plus Gemcitabine Arm A: Pemetrexed plus Carboplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 66 (33.33%)
    19 / 65 (29.23%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    metastases to central nervous system
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subclavian vein thrombosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (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
    condition aggravated
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    medical device complication
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    performance status decreased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 66 (4.55%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea exertional
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pharyngeal inflammation
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood glucose increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    international normalised ratio increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    cardiac failure congestive
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    epilepsy
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    5 / 65 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leukocytosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 66 (3.03%)
    4 / 65 (6.15%)
         occurrences causally related to treatment / all
    2 / 2
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    6 / 65 (9.23%)
         occurrences causally related to treatment / all
    0 / 0
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    epigastric discomfort
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    3 / 65 (4.62%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    hepatic failure
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    jaundice
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    breast cellulitis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    implant site infection
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    staphylococcal sepsis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    streptococcal infection
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypokalaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypocalcaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypercalcaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 65 (1.54%)
         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: 5%
    Non-serious adverse events
    		 Arm B: Vinorelbine plus Gemcitabine Arm A: Pemetrexed plus Carboplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 66 (100.00%)
    62 / 65 (95.38%)
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    21 / 66 (31.82%)
    11 / 65 (16.92%)
         occurrences all number
    30
    16
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    17 / 66 (25.76%)
    9 / 65 (13.85%)
         occurrences all number
    25
    14
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    7 / 66 (10.61%)
    7 / 65 (10.77%)
         occurrences all number
    8
    7
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    11 / 66 (16.67%)
    4 / 65 (6.15%)
         occurrences all number
    16
    4
    weight decreased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    8 / 66 (12.12%)
    3 / 65 (4.62%)
         occurrences all number
    8
    3
    Vascular disorders
    phlebitis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 66 (9.09%)
    0 / 65 (0.00%)
         occurrences all number
    8
    0
    Cardiac disorders
    palpitations
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 66 (7.58%)
    1 / 65 (1.54%)
         occurrences all number
    5
    1
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 66 (6.06%)
    5 / 65 (7.69%)
         occurrences all number
    4
    7
    dysgeusia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 66 (6.06%)
    3 / 65 (4.62%)
         occurrences all number
    4
    3
    headache
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    11 / 66 (16.67%)
    7 / 65 (10.77%)
         occurrences all number
    16
    10
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    9 / 66 (13.64%)
    3 / 65 (4.62%)
         occurrences all number
    14
    3
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    13 / 66 (19.70%)
    14 / 65 (21.54%)
         occurrences all number
    19
    23
    fatigue
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    26 / 66 (39.39%)
    23 / 65 (35.38%)
         occurrences all number
    39
    38
    oedema peripheral
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 66 (9.09%)
    6 / 65 (9.23%)
         occurrences all number
    7
    6
    pyrexia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    21 / 66 (31.82%)
    5 / 65 (7.69%)
         occurrences all number
    33
    6
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    28 / 66 (42.42%)
    32 / 65 (49.23%)
         occurrences all number
    36
    46
    leukopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    35 / 66 (53.03%)
    28 / 65 (43.08%)
         occurrences all number
    84
    79
    lymphopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    8 / 66 (12.12%)
    10 / 65 (15.38%)
         occurrences all number
    15
    13
    neutropenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    51 / 66 (77.27%)
    37 / 65 (56.92%)
         occurrences all number
    154
    120
    thrombocytopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    11 / 66 (16.67%)
    17 / 65 (26.15%)
         occurrences all number
    23
    34
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    9 / 66 (13.64%)
    3 / 65 (4.62%)
         occurrences all number
    12
    3
    abdominal pain upper
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    10 / 66 (15.15%)
    5 / 65 (7.69%)
         occurrences all number
    13
    5
    diarrhoea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    12 / 66 (18.18%)
    7 / 65 (10.77%)
         occurrences all number
    14
    7
    constipation
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    26 / 66 (39.39%)
    18 / 65 (27.69%)
         occurrences all number
    41
    24
    dysphagia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 66 (1.52%)
    4 / 65 (6.15%)
         occurrences all number
    1
    5
    dyspepsia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 66 (9.09%)
    2 / 65 (3.08%)
         occurrences all number
    7
    3
    nausea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    23 / 66 (34.85%)
    31 / 65 (47.69%)
         occurrences all number
    73
    48
    vomiting
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    15 / 66 (22.73%)
    15 / 65 (23.08%)
         occurrences all number
    19
    20
    stomatitis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    11 / 66 (16.67%)
    7 / 65 (10.77%)
         occurrences all number
    12
    8
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    9 / 66 (13.64%)
    5 / 65 (7.69%)
         occurrences all number
    11
    5
    epistaxis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 66 (3.03%)
    5 / 65 (7.69%)
         occurrences all number
    2
    6
    dyspnoea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 66 (9.09%)
    4 / 65 (6.15%)
         occurrences all number
    7
    4
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    16 / 66 (24.24%)
    8 / 65 (12.31%)
         occurrences all number
    16
    8
    pruritus
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    7 / 66 (10.61%)
    6 / 65 (9.23%)
         occurrences all number
    7
    11
    rash
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    9 / 66 (13.64%)
    4 / 65 (6.15%)
         occurrences all number
    10
    4
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 66 (9.09%)
    1 / 65 (1.54%)
         occurrences all number
    6
    1
    insomnia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 66 (4.55%)
    6 / 65 (9.23%)
         occurrences all number
    3
    6
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 66 (7.58%)
    2 / 65 (3.08%)
         occurrences all number
    9
    2
    back pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 66 (9.09%)
    5 / 65 (7.69%)
         occurrences all number
    17
    5
    musculoskeletal pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 66 (9.09%)
    4 / 65 (6.15%)
         occurrences all number
    8
    4
    pain in extremity
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 66 (7.58%)
    0 / 65 (0.00%)
         occurrences all number
    6
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    12 / 66 (18.18%)
    8 / 65 (12.31%)
         occurrences all number
    13
    10
    hyperglycaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 66 (7.58%)
    3 / 65 (4.62%)
         occurrences all number
    5
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Nov 2007
    Changed inclusion criteria.

    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
    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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