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NCT00434642 · OUTCOME

Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma · Source last updated 2017-08-09

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
Not reported
Time frame
From randomization through September 17, 2010 (up to 3 years, 5 months)

What was measured

An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.

Analysis population: Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).

Groups in this outcome

Carboplatin and Gemcitabine + Bevacizumab

Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.

Carboplatin and Gemcitabine + Placebo

Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.

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

Analysis denominator · Participants

GroupSource count
Carboplatin and Gemcitabine + Bevacizumab242
Carboplatin and Gemcitabine + Placebo242

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carboplatin and Gemcitabine + Bevacizumab78.5Not reportedNot reportedNot reportedNot reported
Carboplatin and Gemcitabine + Placebo57.4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    13.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    29.2
    estimate Comment
    The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.
    group Description
    The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    A P-value \< 0.05 was required for significance.
    param Type
    Mean Difference (Final Values)
    param Value
    21.1
    statistical Comment
    The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    13.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    29.2
    estimate Comment
    The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.
    group Description
    The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    A P-value \< 0.05 was required for significance.
    param Type
    Mean Difference (Final Values)
    param Value
    21.1
    statistical Comment
    The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        78.5
      2. group Id
        OG001
        value
        57.4
denoms
  1. counts
    1. group Id
      OG000
      value
      242
    2. group Id
      OG001
      value
      242
    units
    Participants
description
An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
groups
  1. description
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
    id
    OG000
    title
    Carboplatin and Gemcitabine + Bevacizumab
  2. description
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
    id
    OG001
    title
    Carboplatin and Gemcitabine + Placebo
param Type
NUMBER
population Description
Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).
reporting Status
POSTED
time Frame
From randomization through September 17, 2010 (up to 3 years, 5 months)
title
Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice