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ID

37914

Description

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Keywords

Versions (1)
  1. 8/30/19 8/30/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 30, 2019

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Creative Commons BY-NC 3.0
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    Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

    English

    Course 2 (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Description

    Center Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709561
    Patient ID
    Description

    Patient ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit not done
    Description

    Visit not done

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1272696
    Eligibility
    Description

    Eligibility

    Alias
    UMLS CUI-1
    C0013893
    Was this course delayed?
    Description

    Was this course delayed?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0750729
    UMLS CUI [1,2]
    C0205421
    If course was delayed, reason for delay
    Description

    If course was delayed, reason for delay

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0750729
    UMLS CUI [1,2]
    C0205421
    UMLS CUI [1,3]
    C0392360
    If other reason for course delay, specify
    Description

    If other reason for course delay, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0750729
    UMLS CUI [1,2]
    C0205421
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Is the patient eligible to continue in the study?
    Description

    Is the patient eligible to continue in the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1302261
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Systolic Blood Pressure
    Description

    Sitting after 5 mins.

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Description

    Sitting after 5 mins.

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Pulse
    Description

    Sitting after 5 mins.

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Temperature
    Description

    Temperature

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005903
    Temperature Unit
    Description

    Temperature Unit

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1519795
    Weight
    Description

    Light clothes and shoes off. Round to the nearest kg ob Ib.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005910
    Weight Unit
    Description

    Weight Unit

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005910
    UMLS CUI [1,2]
    C0439148
    Body Surface Area
    Description

    Body Surface Area

    Data type

    float

    Measurement units
    • m2
    Alias
    UMLS CUI [1]
    C0005902
    m2
    Administration of Study Medications
    Description

    Administration of Study Medications

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0304229
    Were the study medications administered at Day 1?
    Description

    Were the study medications administered at Day 1?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    If study medication was not administered at Day 1, mark reason(s) why
    Description

    If study medication was not administered at Day 1, mark reason(s) why

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2]
    C2826287
    If other reason for medication not administered, specify
    Description

    If other reason for medication not administered, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2,1]
    C2826287
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Topotecan Administration
    Description

    Topotecan Administration

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0146224
    Was the topotecan dose reduced?
    Description

    Was the topotecan dose reduced?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1707814
    If topotecan dose was reduced, mark reason(s) dose was reduced
    Description

    If topotecan dose was reduced, mark reason(s) dose was reduced

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    If other reason topotecan dose was reduced, specify
    Description

    If other reason topotecan dose was reduced, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Topotecan Dose Modification
    Description

    Topotecan Dose Modification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1707811
    UMLS CUI [1,2]
    C0146224
    If other topotecan dose reduction, specify
    Description

    If other topotecan dose reduction, specify

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C1707814
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    %
    Topotecan scheduled dose
    Description

    Topotecan scheduled dose

    Data type

    float

    Measurement units
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [1,3]
    C0205539
    mg/m2
    Total mg to be given (Topotecan)
    Description

    Total mg to be given (Topotecan)

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2]
    C0146224
    mg
    Date Administered (Topotecan)
    Description

    Date Administered (Topotecan)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2]
    C0146224
    Start Time (Topotecan)
    Description

    Start Time (Topotecan)

    Data type

    time

    Alias
    UMLS CUI [1]
    C1301880
    UMLS CUI [2]
    C0146224
    Stop Time (Topotecan)
    Description

    Stop Time (Topotecan)

    Data type

    time

    Alias
    UMLS CUI [1]
    C1522314
    UMLS CUI [2]
    C0146224
    Was complete dose given? (Topotecan)
    Description

    Was complete dose given? (Topotecan)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [2]
    C0146224
    If complete dose Topotecan was not given, provide actual mg given:
    Description

    If complete dose Topotecan was not given, provide actual mg given:

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [2]
    C0146224
    mg
    Gemcitabine Administration
    Description

    Gemcitabine Administration

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0045093
    Was the gemcitabine dose reduced?
    Description

    Was the gemcitabine dose reduced?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C1707814
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    Description

    If gemcitabine dose was reduced, mark reason(s) dose was reduced

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    If other reason gemcitabine dose was reduced, specify
    Description

    If other reason gemcitabine dose was reduced, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C3146298
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Gemcitabine Dose Modification
    Description

    Gemcitabine Dose Modification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1707811
    UMLS CUI [1,2]
    C0045093
    If other gemcitabine dose reduction, specify
    Description

    If other gemcitabine dose reduction, specify

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C1707814
    UMLS CUI [1,2]
    C0045093
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    %
    Gemcitabine scheduled dose
    Description

    Gemcitabine scheduled dose

    Data type

    float

    Measurement units
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0045093
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [1,3]
    C0205539
    mg/m2
    Total mg to be given (Gemicitabine)
    Description

    Total mg to be given (Gemicitabine)

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [1,3]
    C0045093
    mg
    Date Administered (Gemicitabine)
    Description

    Date Administered (Gemicitabine)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0045093
    Start Time (Gemicitabine)
    Description

    Start Time (Gemicitabine)

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0045093
    Stop Time (Gemicitabine)
    Description

    Stop Time (Gemicitabine)

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0045093
    Was complete dose given? (Gemicitabine)
    Description

    Was complete dose given? (Gemicitabine)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [1,3]
    C0045093
    If complete dose Gemcitabine was not given, provide actual mg given:
    Description

    If complete dose Gemcitabine was not given, provide actual mg given:

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [1,3]
    C0045093
    mg
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    Course 2 (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1709561 (UMLS CUI [1])
    Patient ID
    Item
    Patient ID
    text
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit not done
    integer
    C0545082 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Visit not done
    Code List
    Visit not done
    CL Item
    Visit Not Done (1)
    Item Group
    Eligibility
    C0013893 (UMLS CUI-1)
    Was this course delayed?
    Item
    Was this course delayed?
    boolean
    C0750729 (UMLS CUI [1,1])
    C0205421 (UMLS CUI [1,2])
    Item
    If course was delayed, reason for delay
    integer
    C0750729 (UMLS CUI [1,1])
    C0205421 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    If course was delayed, reason for delay
    Code List
    If course was delayed, reason for delay
    CL Item
    Hemoglobin < 9.0 g/dL [90g/L] (1)
    CL Item
    Neutrophils < 1000 cells/mm3 [< 1.0 x 10*9/L] (2)
    CL Item
    Platelets < 100,000/mm3 [< 100.0 x 10*9/L] (3)
    CL Item
    Clinically significant non-hematologic drug related toxicity (4)
    CL Item
    Other, specify (5)
    If other reason for course delay, specify
    Item
    If other reason for course delay, specify
    text
    C0750729 (UMLS CUI [1,1])
    C0205421 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Is the patient eligible to continue in the study?
    Item
    Is the patient eligible to continue in the study?
    boolean
    C1302261 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature Unit
    integer
    C0005903 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Temperature Unit
    Code List
    Temperature Unit
    CL Item
    °C (1)
    CL Item
    °F (2)
    Weight
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    Item
    Weight Unit
    integer
    C0005910 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Weight Unit
    Code List
    Weight Unit
    CL Item
    kg (1)
    CL Item
    Ib (2)
    Body Surface Area
    Item
    Body Surface Area
    float
    C0005902 (UMLS CUI [1])
    Item Group
    Administration of Study Medications
    C3469597 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    Were the study medications administered at Day 1?
    Item
    Were the study medications administered at Day 1?
    boolean
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    If study medication was not administered at Day 1, mark reason(s) why
    integer
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [2])
    If study medication was not administered at Day 8, mark reason(s) why
    Code List
    If study medication was not administered at Day 1, mark reason(s) why
    CL Item
    Hematology (1)
    CL Item
    Non-Hematology (2)
    CL Item
    Other, specify (3)
    If other reason for medication not administered, specify
    Item
    If other reason for medication not administered, specify
    text
    C3469597 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item Group
    Topotecan Administration
    C3469597 (UMLS CUI-1)
    C0146224 (UMLS CUI-2)
    Was the topotecan dose reduced?
    Item
    Was the topotecan dose reduced?
    boolean
    C0146224 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    Item
    If topotecan dose was reduced, mark reason(s) dose was reduced
    integer
    C0146224 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    If topotecan dose was reduced, mark reason(s) dose was reduced
    Code List
    If topotecan dose was reduced, mark reason(s) dose was reduced
    CL Item
    Hematology (1)
    CL Item
    Non-Hematology, specify (2)
    If other reason topotecan dose was reduced, specify
    Item
    If other reason topotecan dose was reduced, specify
    text
    C0146224 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item
    Topotecan Dose Modification
    integer
    C1707811 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    Topotecan Dose Modification
    Code List
    Topotecan Dose Modification
    CL Item
    No change (2)
    CL Item
    25% reduction (3)
    CL Item
    50% reduction (4)
    CL Item
    Other, specify (5)
    CL Item
    Re-escalation (1)
    If other topotecan dose reduction, specify
    Item
    If other topotecan dose reduction, specify
    integer
    C1707814 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Topotecan scheduled dose
    Item
    Topotecan scheduled dose
    float
    C0146224 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C0205539 (UMLS CUI [1,3])
    Total mg to be given (Topotecan)
    Item
    Total mg to be given (Topotecan)
    float
    C0178602 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Date Administered (Topotecan)
    Item
    Date Administered (Topotecan)
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Start Time (Topotecan)
    Item
    Start Time (Topotecan)
    time
    C1301880 (UMLS CUI [1])
    C0146224 (UMLS CUI [2])
    Stop Time (Topotecan)
    Item
    Stop Time (Topotecan)
    time
    C1522314 (UMLS CUI [1])
    C0146224 (UMLS CUI [2])
    Was complete dose given? (Topotecan)
    Item
    Was complete dose given? (Topotecan)
    boolean
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    If complete dose Topotecan was not given, provide actual mg given:
    Item
    If complete dose Topotecan was not given, provide actual mg given:
    float
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Item Group
    Gemcitabine Administration
    C3469597 (UMLS CUI-1)
    C0045093 (UMLS CUI-2)
    Was the gemcitabine dose reduced?
    Item
    Was the gemcitabine dose reduced?
    boolean
    C0045093 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    Item
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    integer
    C0045093 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    Code List
    If gemcitabine dose was reduced, mark reason(s) dose was reduced
    CL Item
    Hematology  (1)
    CL Item
    Non-Hematology, specify (2)
    If other reason gemcitabine dose was reduced, specify
    Item
    If other reason gemcitabine dose was reduced, specify
    text
    C0045093 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C3146298 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item
    Gemcitabine Dose Modification
    integer
    C1707811 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    Gemcitabine Dose Modification
    Code List
    Gemcitabine Dose Modification
    CL Item
    No change  (2)
    CL Item
    25% reduction  (3)
    CL Item
    50% reduction  (4)
    CL Item
    Other, specify (5)
    CL Item
    Re-escalation (1)
    If other gemcitabine dose reduction, specify
    Item
    If other gemcitabine dose reduction, specify
    integer
    C1707814 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Gemcitabine scheduled dose
    Item
    Gemcitabine scheduled dose
    float
    C0045093 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C0205539 (UMLS CUI [1,3])
    Total mg to be given (Gemicitabine)
    Item
    Total mg to be given (Gemicitabine)
    float
    C0178602 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
    Date Administered (Gemicitabine)
    Item
    Date Administered (Gemicitabine)
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
    Start Time (Gemicitabine)
    Item
    Start Time (Gemicitabine)
    time
    C1301880 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    Stop Time (Gemicitabine)
    Item
    Stop Time (Gemicitabine)
    time
    C1522314 (UMLS CUI [1,1])
    C0045093 (UMLS CUI [1,2])
    Was complete dose given? (Gemicitabine)
    Item
    Was complete dose given? (Gemicitabine)
    boolean
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
    If complete dose Gemcitabine was not given, provide actual mg given:
    Item
    If complete dose Gemcitabine was not given, provide actual mg given:
    float
    C3174092 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0045093 (UMLS CUI [1,3])
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