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NCT00262847 · FLOW

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Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2019-07-23

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

groups
  1. description
    Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    FG000
    title
    Arm I (Placebo, Paclitaxel, Carboplatin)
  2. description
    Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    FG001
    title
    Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
  3. description
    Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
    id
    FG002
    title
    Arm III (Paclitaxel, Carboplatin, Bevacizumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        309
      2. group Id
        FG001
        num Subjects
        274
      3. group Id
        FG002
        num Subjects
        195
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        52
      3. group Id
        FG002
        num Subjects
        47
      type
      Patient Refusal
    3. reasons
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        108
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        11
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Concomitant disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        27
      type
      Other Reasons
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      type
      Did not receive study treatment
    milestones
    1. achievements
      1. comment
        Total enrolled and included in efficacy analysis
        group Id
        FG000
        num Subjects
        625
      2. comment
        Total enrolled and included in efficacy analysis
        group Id
        FG001
        num Subjects
        625
      3. comment
        Total enrolled and included in efficacy analysis
        group Id
        FG002
        num Subjects
        623
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        227
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        518
      2. group Id
        FG001
        num Subjects
        513
      3. group Id
        FG002
        num Subjects
        396
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between October 2005 and June 2009, 1873 women were enrolled from 336 institutions in the United States, Canada, South Korea, and Japan.
Complete source fields
groups
  1. description
    Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    FG000
    title
    Arm I (Placebo, Paclitaxel, Carboplatin)
  2. description
    Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    FG001
    title
    Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
  3. description
    Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
    id
    FG002
    title
    Arm III (Paclitaxel, Carboplatin, Bevacizumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        309
      2. group Id
        FG001
        num Subjects
        274
      3. group Id
        FG002
        num Subjects
        195
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        52
      3. group Id
        FG002
        num Subjects
        47
      type
      Patient Refusal
    3. reasons
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        108
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        11
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Concomitant disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        27
      type
      Other Reasons
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      type
      Did not receive study treatment
    milestones
    1. achievements
      1. comment
        Total enrolled and included in efficacy analysis
        group Id
        FG000
        num Subjects
        625
      2. comment
        Total enrolled and included in efficacy analysis
        group Id
        FG001
        num Subjects
        625
      3. comment
        Total enrolled and included in efficacy analysis
        group Id
        FG002
        num Subjects
        623
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        227
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        518
      2. group Id
        FG001
        num Subjects
        513
      3. group Id
        FG002
        num Subjects
        396
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between October 2005 and June 2009, 1873 women were enrolled from 336 institutions in the United States, Canada, South Korea, and Japan.

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Preserved source evidence · Not medical advice