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NCT01010126 · OUTCOME

Time to Disease Progression

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer · Source last updated 2019-01-25

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Time from registration to disease progression, assessed up to 3 years

What was measured

Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration.

Analysis population: All patients that began protocol treatment and were evaluated for response are included in this analysis.

Groups in this outcome

Endometrial Cohort

Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Ovarian Cohort

Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Hepatocellular Cohort

Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Carcinoid Cohort

Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Islet Cell (Double Agent) Cohort

Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Islet Cell (Bevacizumab-only) Cohort

Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Endometrial Cohort26
Ovarian Cohort58
Hepatocellular Cohort27
Carcinoid Cohort55
Islet Cell (Double Agent) Cohort54
Islet Cell (Bevacizumab-only) Cohort24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Endometrial Cohort6.0Not reported2.59.8Not reported
Ovarian Cohort5.6Not reported4.36.4Not reported
Hepatocellular Cohort8.0Not reported5.810.9Not reported
Carcinoid Cohort15.2Not reported11.424.2Not reported
Islet Cell (Double Agent) Cohort13.1Not reported11.216.6Not reported
Islet Cell (Bevacizumab-only) Cohort18.0Not reported10.637.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        9.8
        value
        6.0
      2. group Id
        OG001
        lower Limit
        4.3
        upper Limit
        6.4
        value
        5.6
      3. group Id
        OG002
        lower Limit
        5.8
        upper Limit
        10.9
        value
        8.0
      4. group Id
        OG003
        lower Limit
        11.4
        upper Limit
        24.2
        value
        15.2
      5. group Id
        OG004
        lower Limit
        11.2
        upper Limit
        16.6
        value
        13.1
      6. group Id
        OG005
        lower Limit
        10.6
        upper Limit
        37.0
        value
        18.0
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      58
    3. group Id
      OG002
      value
      27
    4. group Id
      OG003
      value
      55
    5. group Id
      OG004
      value
      54
    6. group Id
      OG005
      value
      24
    units
    Participants
description
Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Endometrial Cohort
  2. description
    Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Ovarian Cohort
  3. description
    Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    Hepatocellular Cohort
  4. description
    Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG003
    title
    Carcinoid Cohort
  5. description
    Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG004
    title
    Islet Cell (Double Agent) Cohort
  6. description
    Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG005
    title
    Islet Cell (Bevacizumab-only) Cohort
param Type
MEDIAN
population Description
All patients that began protocol treatment and were evaluated for response are included in this analysis.
reporting Status
POSTED
time Frame
Time from registration to disease progression, assessed up to 3 years
title
Time to Disease Progression
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice