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NCT00357500 · BASELINE

Baseline characteristics

Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer · Source last updated 2014-10-01

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
      97
    units
    Participants
groups
  1. description
    Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
    id
    BG000
    title
    5-drug Metronmic Antiangiogenic Regimen
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.52
          upper Limit
          21
          value
          10
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      High Grade Glioma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Ependymoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Low Grade Glioma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Bone Tumors
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Medulloblastoma/PNET
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Neuroblastoma
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Leukemia/Lymphoma
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Miscellaneous CNS Tumors
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Miscellaneous non-CNS Tumors
    description
    Patients were stratified within 7 disease strata and an 8th 'miscellaneous' stratum.
    param Type
    NUMBER
    title
    Disease Group
    unit Of Measure
    participants
population Description
The analysis population represents patients who started treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      97
    units
    Participants
groups
  1. description
    Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
    id
    BG000
    title
    5-drug Metronmic Antiangiogenic Regimen
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.52
          upper Limit
          21
          value
          10
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      High Grade Glioma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Ependymoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Low Grade Glioma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Bone Tumors
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Medulloblastoma/PNET
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Neuroblastoma
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Leukemia/Lymphoma
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Miscellaneous CNS Tumors
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Miscellaneous non-CNS Tumors
    description
    Patients were stratified within 7 disease strata and an 8th 'miscellaneous' stratum.
    param Type
    NUMBER
    title
    Disease Group
    unit Of Measure
    participants
population Description
The analysis population represents patients who started treatment.

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

Preserved source evidence · Not medical advice