Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01064648 · BASELINE

Baseline characteristics

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma · Source last updated 2026-09-09

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
      20
    2. group Id
      BG001
      value
      45
    3. group Id
      BG002
      value
      47
    4. group Id
      BG003
      value
      112
    units
    Participants
groups
  1. description
    All participants from Phase I
    id
    BG000
    title
    Phase I All Participants
  2. description
    Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
    id
    BG001
    title
    Phase II Cisplatin-pemetrexed Cediranib 20mg
  3. description
    Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
    id
    BG002
    title
    Phase II Cisplatin-pemetrexed Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43.6
          upper Limit
          83.6
          value
          64.4
        2. group Id
          BG001
          lower Limit
          45.5
          upper Limit
          82.1
          value
          71.3
        3. group Id
          BG002
          lower Limit
          50.9
          upper Limit
          85.3
          value
          71.8
        4. group Id
          BG003
          lower Limit
          43.6
          upper Limit
          85.3
          value
          69.8
    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
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          93
        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
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          104
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          100
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          105
        title
        0-1
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        2
    description
    Patients will be graded according to the Zubrod Performance Status Scale: 0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. The higher grade is, the worse performance status is.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Zubrod Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          87
        title
        Epitheliod or mesothelioma, NOS
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          25
        title
        Biphasic or sarcomatoid
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          22
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          90
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior history of radiation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          91
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior history of definitive surgery
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          92
        title
        Measurable
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          20
        title
        Non-measurable
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease per RECIST 1.1
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          85
        title
        Measurable
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          27
        title
        Non-measurable
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease per Modified RECIST for Pleural Tumors
    unit Of Measure
    Participants
population Description
117 participants were enrolled, only 112 participants were included in the analysis: 5 patients were either not eligible or not analyzable. Thus these 5 patients were excluded from any analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    2. group Id
      BG001
      value
      45
    3. group Id
      BG002
      value
      47
    4. group Id
      BG003
      value
      112
    units
    Participants
groups
  1. description
    All participants from Phase I
    id
    BG000
    title
    Phase I All Participants
  2. description
    Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
    id
    BG001
    title
    Phase II Cisplatin-pemetrexed Cediranib 20mg
  3. description
    Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
    id
    BG002
    title
    Phase II Cisplatin-pemetrexed Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43.6
          upper Limit
          83.6
          value
          64.4
        2. group Id
          BG001
          lower Limit
          45.5
          upper Limit
          82.1
          value
          71.3
        3. group Id
          BG002
          lower Limit
          50.9
          upper Limit
          85.3
          value
          71.8
        4. group Id
          BG003
          lower Limit
          43.6
          upper Limit
          85.3
          value
          69.8
    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
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          93
        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
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          104
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          100
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          105
        title
        0-1
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        2
    description
    Patients will be graded according to the Zubrod Performance Status Scale: 0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. The higher grade is, the worse performance status is.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Zubrod Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          87
        title
        Epitheliod or mesothelioma, NOS
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          25
        title
        Biphasic or sarcomatoid
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          22
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          90
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior history of radiation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          91
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior history of definitive surgery
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          92
        title
        Measurable
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          20
        title
        Non-measurable
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease per RECIST 1.1
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          85
        title
        Measurable
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          27
        title
        Non-measurable
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease per Modified RECIST for Pleural Tumors
    unit Of Measure
    Participants
population Description
117 participants were enrolled, only 112 participants were included in the analysis: 5 patients were either not eligible or not analyzable. Thus these 5 patients were excluded from any analysis.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice