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NCT00112736 · BASELINE

Baseline characteristics

Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma · Source last updated 2015-06-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      9
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      43
    4. group Id
      BG003
      value
      68
    units
    Participants
groups
  1. description
    PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity. erlotinib: Given orally temsirolimus: Given IV
    id
    BG000
    title
    Phase I n=9
  2. description
    Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. Anaplastic Glioma erlotinib: Given orally temsirolimus: Given IV
    id
    BG001
    title
    Phase II n=16
  3. description
    Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. Glioblastoma erlotinib: Given orally temsirolimus: Given IV
    id
    BG002
    title
    Phase II n=43
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33
          upper Limit
          74
          value
          57
        2. group Id
          BG001
          lower Limit
          29
          upper Limit
          72
          value
          47
        3. group Id
          BG002
          lower Limit
          20
          upper Limit
          69
          value
          50
        4. group Id
          BG003
          lower Limit
          20
          upper Limit
          74
          value
          51
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          48
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          70
          upper Limit
          100
          value
          90
        2. group Id
          BG001
          lower Limit
          60
          upper Limit
          100
          value
          90
        3. group Id
          BG002
          lower Limit
          60
          upper Limit
          100
          value
          90
        4. group Id
          BG003
          lower Limit
          60
          upper Limit
          100
          value
          90
    description
    The KPS scores range from 0 (lowest score) to 100 (highest score). The higher the score the better able to carry out daily activities 100-80: able to carry on normal activity and to work; No special care 70-50: Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed 40-10: unable to care for self, requires equivalent of institutional or hospital care; diseases may be progressing rapidly 0: dead
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Karnofsky Performance Scale (KPS)
    unit Of Measure
    units on a scale
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          3
          value
          2
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          3
          value
          1
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          3
          value
          1
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          3
          value
          1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior Chemotherapy treatments
    unit Of Measure
    treatments
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          19
      title
      anaplastic glioma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          49
      title
      glioblastoma
    param Type
    NUMBER
    title
    Histology
    unit Of Measure
    participants
population Description
pts had to meet eligibility criteria and recieve at least one dose of treatment. 22 eligible pts enrolled in phase 1, but 1 pt declined before starting any treatment and was excluded from analysis - 12 pts were treated at MTD and thus included in the Phase 2 analysis, hence only 9 patients remained for analysis for phase 1
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      9
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      43
    4. group Id
      BG003
      value
      68
    units
    Participants
groups
  1. description
    PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity. erlotinib: Given orally temsirolimus: Given IV
    id
    BG000
    title
    Phase I n=9
  2. description
    Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. Anaplastic Glioma erlotinib: Given orally temsirolimus: Given IV
    id
    BG001
    title
    Phase II n=16
  3. description
    Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. Glioblastoma erlotinib: Given orally temsirolimus: Given IV
    id
    BG002
    title
    Phase II n=43
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33
          upper Limit
          74
          value
          57
        2. group Id
          BG001
          lower Limit
          29
          upper Limit
          72
          value
          47
        3. group Id
          BG002
          lower Limit
          20
          upper Limit
          69
          value
          50
        4. group Id
          BG003
          lower Limit
          20
          upper Limit
          74
          value
          51
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          48
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          70
          upper Limit
          100
          value
          90
        2. group Id
          BG001
          lower Limit
          60
          upper Limit
          100
          value
          90
        3. group Id
          BG002
          lower Limit
          60
          upper Limit
          100
          value
          90
        4. group Id
          BG003
          lower Limit
          60
          upper Limit
          100
          value
          90
    description
    The KPS scores range from 0 (lowest score) to 100 (highest score). The higher the score the better able to carry out daily activities 100-80: able to carry on normal activity and to work; No special care 70-50: Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed 40-10: unable to care for self, requires equivalent of institutional or hospital care; diseases may be progressing rapidly 0: dead
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Karnofsky Performance Scale (KPS)
    unit Of Measure
    units on a scale
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          3
          value
          2
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          3
          value
          1
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          3
          value
          1
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          3
          value
          1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior Chemotherapy treatments
    unit Of Measure
    treatments
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          19
      title
      anaplastic glioma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          49
      title
      glioblastoma
    param Type
    NUMBER
    title
    Histology
    unit Of Measure
    participants
population Description
pts had to meet eligibility criteria and recieve at least one dose of treatment. 22 eligible pts enrolled in phase 1, but 1 pt declined before starting any treatment and was excluded from analysis - 12 pts were treated at MTD and thus included in the Phase 2 analysis, hence only 9 patients remained for analysis for phase 1

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Preserved source evidence · Not medical advice