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NCT01081262 · OUTCOME

Objective Tumor Response

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer · Source last updated 2026-08-28

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years

What was measured

Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.\>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR

Analysis population: All randomized patients with measurable disease

Groups in this outcome

Arm I (Carboplatin and Paclitaxel)

Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Arm II (Oxaliplatin and Capecitabine)

Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies

Arm III (Carboplatin, Paclitaxel, Bevacizumab)

Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)

Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Carboplatin and Paclitaxel)9
Arm II (Oxaliplatin and Capecitabine)11
Arm III (Carboplatin, Paclitaxel, Bevacizumab)7
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)5

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carboplatin and Paclitaxel)22Not reported360Not reported
Arm II (Oxaliplatin and Capecitabine)27Not reported661Not reported
Arm III (Carboplatin, Paclitaxel, Bevacizumab)43Not reported1082Not reported
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)40Not reported585Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        60
        value
        22
      2. group Id
        OG001
        lower Limit
        6
        upper Limit
        61
        value
        27
      3. group Id
        OG002
        lower Limit
        10
        upper Limit
        82
        value
        43
      4. group Id
        OG003
        lower Limit
        5
        upper Limit
        85
        value
        40
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      5
    units
    Participants
description
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.\>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Arm I (Carboplatin and Paclitaxel)
  2. description
    Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG001
    title
    Arm II (Oxaliplatin and Capecitabine)
  3. description
    Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG002
    title
    Arm III (Carboplatin, Paclitaxel, Bevacizumab)
  4. description
    Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG003
    title
    Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
param Type
NUMBER
population Description
All randomized patients with measurable disease
reporting Status
POSTED
time Frame
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years
title
Objective Tumor Response
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice