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ID

37962

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

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Versions (1)
  1. 9/2/19 9/2/19 -
Copyright Holder

GlaxoSmithKline

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September 2, 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 -- Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

    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
    Course Number
    Description

    Course Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0750729
    Review of Disease Status
    Description

    Review of Disease Status

    Alias
    UMLS CUI-1
    C0699749
    UMLS CUI-2
    C0699752
    Date of Assessment
    Description

    Date of Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Assessment not done
    Description

    Assessment not done

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C1272696
    Reason for assessment not done
    Description

    Mark only one

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C2826287
    Date of Progression
    Description

    Date of Progression

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0242656
    UMLS CUI [1,2]
    C0011008
    Lesion Evaluation or Clinical Assessment
    Description

    Mark one

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [2]
    C4534461
    Therapeutic Interventions
    Description

    Therapeutic Interventions

    Alias
    UMLS CUI-1
    C0808232
    Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
    Description

    If “Yes", complete Therapeutic Interventions log.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0808232
    UMLS CUI [2,1]
    C0013221
    UMLS CUI [2,2]
    C0304229
    End of Course Eligibility
    Description

    End of Course Eligibility

    Alias
    UMLS CUI-1
    C0013893
    UMLS CUI-2
    C0750729
    UMLS CUI-3
    C0444930
    Did the patient meet the following criteria by Day 28?
    Description

    Hemoglobin >= 9.0 g/dL [90 g/L] Neutrophils >= 1000 cells/mm3 [>= 1.0 x 10*9 /L] Platelets >= 100,000/mm3 [>= 100.0 x 10*9 /L] No clinically significant non-hematologic drug related toxicity If "Yes“, proceed to next course. If "No”, complete Unscheduled Laboratory Tests.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013893
    Unscheduled Laboratory Tests - Hematology
    Description

    Unscheduled Laboratory Tests - Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0474523
    Hematology Sample Date
    Description

    Hematology Sample Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1302413
    Hematology Laboratory Name
    Description

    Hematology Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C3258037
    Unscheduled Laboratory Tests - Hematology
    Description

    Unscheduled Laboratory Tests - Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0474523
    Hematology Test
    Description

    Hematology Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Hematology - No Result
    Description

    Hematology - No Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C1274040
    Hematology - Value
    Description

    Hematology - Value

    Data type

    text

    Alias
    UMLS CUI [1]
    C0474523
    Hematology - Value out of range and NOT clinically significant
    Description

    Hematology - Value out of range and NOT clinically significant

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Hematology - Value out of range and clinically significant
    Description

    Hematology - Value out of range and clinically significant

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Therapeutic Interventions
    Description

    Therapeutic Interventions

    Alias
    UMLS CUI-1
    C0808232
    Line Number
    Description

    Line Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449788
    Procedure
    Description

    Procedure

    Data type

    text

    Alias
    UMLS CUI [1]
    C2700391
    Procedure details
    Description

    Procedure details

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2700391
    UMLS CUI [1,2]
    C1522508
    Procedure Time
    Description

    Procedure Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2700391
    UMLS CUI [1,2]
    C0040223
    Procedure Date
    Description

    Procedure Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2700391
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Course -- Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

    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])
    Course Number
    Item
    Course Number
    integer
    C0237753 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Item Group
    Review of Disease Status
    C0699749 (UMLS CUI-1)
    C0699752 (UMLS CUI-2)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Assessment not done
    integer
    C0220825 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Assessment not done
    Code List
    Assessment not done
    CL Item
    Not Done (1)
    Item
    Reason for assessment not done
    integer
    C0220825 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    Reason for assessment not done
    Code List
    Reason for assessment not done
    CL Item
    Non-evaluable  (1)
    CL Item
    Complete Response  (2)
    CL Item
    Partial Response  (3)
    CL Item
    Stable Disease  (4)
    CL Item
    Disease Progression (5)
    Date of Progression
    Item
    Date of Progression
    date
    C0242656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Lesion Evaluation or Clinical Assessment
    integer
    C0221198 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    C4534461 (UMLS CUI [2])
    Lesion Evaluation or Clinical Assessment
    Code List
    Lesion Evaluation or Clinical Assessment
    CL Item
    Lesion Evaluation (1)
    CL Item
    Clinical Assessment (2)
    Item Group
    Therapeutic Interventions
    C0808232 (UMLS CUI-1)
    Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
    Item
    Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
    boolean
    C0808232 (UMLS CUI [1])
    C0013221 (UMLS CUI [2,1])
    C0304229 (UMLS CUI [2,2])
    Item Group
    End of Course Eligibility
    C0013893 (UMLS CUI-1)
    C0750729 (UMLS CUI-2)
    C0444930 (UMLS CUI-3)
    Did the patient meet the following criteria by Day 28?
    Item
    Did the patient meet the following criteria by Day 28?
    boolean
    C0013893 (UMLS CUI [1])
    Item Group
    Unscheduled Laboratory Tests - Hematology
    C0022885 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0474523 (UMLS CUI-3)
    Hematology Sample Date
    Item
    Hematology Sample Date
    date
    C0474523 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Hematology Laboratory Name
    Item
    Hematology Laboratory Name
    text
    C0474523 (UMLS CUI [1,1])
    C3258037 (UMLS CUI [1,2])
    Item Group
    Unscheduled Laboratory Tests - Hematology
    C0022885 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0474523 (UMLS CUI-3)
    Item
    Hematology Test
    integer
    C0018941 (UMLS CUI [1])
    Haematology Test
    Code List
    Hematology Test
    CL Item
    Hemoglobin  (1)
    CL Item
    Hematocrit  (2)
    CL Item
    RBC  (3)
    CL Item
    WBC  (4)
    CL Item
    Neutrophils  (5)
    CL Item
    Bands  (6)
    CL Item
    Lymphocytes  (7)
    CL Item
    Monocytes  (8)
    CL Item
    Eosinophils  (9)
    CL Item
    Basophils  (10)
    CL Item
    Platelets  (11)
    CL Item
    Granulocytes (12)
    Item
    Hematology - No Result
    integer
    C0018941 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Haematology - No Result
    Code List
    Hematology - No Result
    CL Item
    No Result (1)
    Hematology - Value
    Item
    Hematology - Value
    text
    C0474523 (UMLS CUI [1])
    Item
    Hematology - Value out of range and NOT clinically significant
    integer
    C0474523 (UMLS CUI [1,1])
    C0438215 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Haematology - Value out of range and NOT clinically significant
    Code List
    Hematology - Value out of range and NOT clinically significant
    CL Item
    Value out of range and NOT clinically significant (2)
    Item
    Hematology - Value out of range and clinically significant
    integer
    C0474523 (UMLS CUI [1,1])
    C0438215 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Haematology - Value out of range and clinically significant
    Code List
    Hematology - Value out of range and clinically significant
    CL Item
    Value out of range and clinically significant (3)
    Item Group
    Therapeutic Interventions
    C0808232 (UMLS CUI-1)
    Line Number
    Item
    Line Number
    integer
    C0449788 (UMLS CUI [1])
    Procedure
    Item
    Procedure
    text
    C2700391 (UMLS CUI [1])
    Procedure details
    Item
    Procedure details
    text
    C2700391 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    Procedure Time
    Item
    Procedure Time
    time
    C2700391 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Procedure Date
    Item
    Procedure Date
    date
    C2700391 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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