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NCT00407485 · OUTCOME

Tumor Response Rate

VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium · Source last updated 2014-10-20

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

Measure
NUMBER
Unit
percentage of responders
Interval / dispersion
95% Confidence Interval
Time frame
From the start of the treatment until disease progression or recurrence, assessed up to 4 years

What was measured

Response rate (RR) and progression free survival (PFS) were assessed in a 2-stage accrual design (22+18). A maximum of 40 patients were to be accrued to rule out a null hypothesized RR of 4% and PFS of 3 months versus alternative of 15% RR and 5.4 months PFS (corresponding to 4 month PFS of 40% vs 60%) with α=0.12 and β=0.19. If no more than 1 objective response (no more than 4.5%), and no more than 10 instances of 4-month PFS (no more than 45%), were observed among the initial 22 patients, the study would be terminated early and declared negative. Tumor response was evaluated by CT or MRI using RECIST v1.0 criteria. Responders were confirmed partial or complete responses to treatment.

Groups in this outcome

Treatment (Ziv-aflibercept)

Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative 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
Treatment (Ziv-aflibercept)22

Reported measurements

Source class 1
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Ziv-aflibercept)4.5Not reported0.122.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        22.8
        value
        4.5
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Response rate (RR) and progression free survival (PFS) were assessed in a 2-stage accrual design (22+18). A maximum of 40 patients were to be accrued to rule out a null hypothesized RR of 4% and PFS of 3 months versus alternative of 15% RR and 5.4 months PFS (corresponding to 4 month PFS of 40% vs 60%) with α=0.12 and β=0.19. If no more than 1 objective response (no more than 4.5%), and no more than 10 instances of 4-month PFS (no more than 45%), were observed among the initial 22 patients, the study would be terminated early and declared negative. Tumor response was evaluated by CT or MRI using RECIST v1.0 criteria. Responders were confirmed partial or complete responses to treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
    id
    OG000
    title
    Treatment (Ziv-aflibercept)
param Type
NUMBER
reporting Status
POSTED
time Frame
From the start of the treatment until disease progression or recurrence, assessed up to 4 years
title
Tumor Response Rate
type
PRIMARY
unit Of Measure
percentage of responders

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

Preserved source evidence · Not medical advice