NCT01010126 · OUTCOME

Overall Survival

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 death, assessed up to 3 years

What was measured

Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.

Analysis population: All patients that received study intervention and were followed for survival were 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

Hepatocellular Cohort

Carcinoid Cohort

Islet Cell (Double Agent) Cohort

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

Group	Source count
Endometrial Cohort	26
Ovarian Cohort	58
Hepatocellular Cohort	27
Carcinoid Cohort	57
Islet Cell (Double Agent) Cohort	58
Islet Cell (Bevacizumab-only) Cohort	24

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Endometrial Cohort	11.5	Not reported	6.5	NA	Too few deaths occurred to estimate an upper 95% CI.
Ovarian Cohort	16.3	Not reported	11.1	21.9	Not reported
Hepatocellular Cohort	14.8	Not reported	9.7	18.1	Not reported
Carcinoid Cohort	32.7	Not reported	25.2	38.3	Not reported
Islet Cell (Double Agent) Cohort	35.0	Not reported	14.6	NA	Too few deaths occurred to estimate an upper 95% CI.
Islet Cell (Bevacizumab-only) Cohort	NA	Not reported	30.6	NA	Too few deaths occurred to estimate a median or an upper 95% CI.

Complete source fields

classes

categories
measurements
comment
Too few deaths occurred to estimate an upper 95% CI.
group Id
OG000
lower Limit
6.5
upper Limit
NA
value
11.5
group Id
OG001
lower Limit
11.1
upper Limit
21.9
value
16.3
group Id
OG002
lower Limit
9.7
upper Limit
18.1
value
14.8
group Id
OG003
lower Limit
25.2
upper Limit
38.3
value
32.7
comment
Too few deaths occurred to estimate an upper 95% CI.
group Id
OG004
lower Limit
14.6
upper Limit
NA
value
35.0
comment
Too few deaths occurred to estimate a median or an upper 95% CI.
group Id
OG005
lower Limit
30.6
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
26
group Id
OG001
value
58
group Id
OG002
value
27
group Id
OG003
value
57
group Id
OG004
value
58
group Id
OG005
value
24
units
Participants

description

Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.

dispersion Type

95% Confidence Interval

groups

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
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
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
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
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
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 received study intervention and were followed for survival were included in this analysis.

reporting Status

POSTED

time Frame

Time from registration to death, assessed up to 3 years

title

Overall Survival

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice