NCT01010126 · OUTCOME

Progression Free Survival Rate

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: NUMBER
Unit: proportion of patients
Interval / dispersion: 95% Confidence Interval
Time frame: 6 months

What was measured

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable patients enrolled on study. Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval).

Analysis population: All patients that received study 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

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	55
Islet Cell (Double Agent) Cohort	54
Islet Cell (Bevacizumab-only) Cohort	24

Reported measurements

Source class 1

Values in proportion of patients · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Endometrial Cohort	0.52	Not reported	0.35	0.77	Not reported
Ovarian Cohort	0.40	Not reported	0.29	0.55	Not reported
Hepatocellular Cohort	0.71	Not reported	0.54	0.94	Not reported
Carcinoid Cohort	0.84	Not reported	0.75	0.95	Not reported
Islet Cell (Double Agent) Cohort	0.85	Not reported	0.75	0.95	Not reported
Islet Cell (Bevacizumab-only) Cohort	0.87	Not reported	0.74	1.00	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.35
upper Limit
0.77
value
0.52
group Id
OG001
lower Limit
0.29
upper Limit
0.55
value
0.40
group Id
OG002
lower Limit
0.54
upper Limit
0.94
value
0.71
group Id
OG003
lower Limit
0.75
upper Limit
0.95
value
0.84
group Id
OG004
lower Limit
0.75
upper Limit
0.95
value
0.85
group Id
OG005
lower Limit
0.74
upper Limit
1.00
value
0.87

denoms

counts
group Id
OG000
value
26
group Id
OG001
value
58
group Id
OG002
value
27
group Id
OG003
value
55
group Id
OG004
value
54
group Id
OG005
value
24
units
Participants

description

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

NUMBER

population Description

All patients that received study treatment and were evaluated for response are included in this analysis

reporting Status

POSTED

time Frame

6 months

title

Progression Free Survival Rate

type

PRIMARY

unit Of Measure

proportion of patients

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Preserved source evidence · Not medical advice