NCT01064648 · OUTCOME

Overall Survival (Phase II)

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma · Source last updated 2026-09-09

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

Measure: MEDIAN
Unit: month
Interval / dispersion: 95% Confidence Interval
Time frame: From date of registration to death.Disease assessment will be repeated every 6 weeks until disease progression. After progression, follow up will occur every 6 months for the first two years and then at the end of the third year after registration.

What was measured

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Analysis population: Only eligible and analyzable patients are included in the analysis.

Groups in this outcome

Phase II Cisplatin-pemetrexed Cediranib 20mg

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV

Phase II Cisplatin-pemetrexed Placebo

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV

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
Phase II Cisplatin-pemetrexed Cediranib 20mg	45
Phase II Cisplatin-pemetrexed Placebo	47

Reported measurements

Source class 1

Values in month · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase II Cisplatin-pemetrexed Cediranib 20mg	10	Not reported	7.7	13.5	Not reported
Phase II Cisplatin-pemetrexed Placebo	8.5	Not reported	6.6	13.8	Not reported

Source statistical analyses

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

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
80
ci Upper Limit
1.17
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.28
p Value Comment
1-sided p-value
param Type
Hazard Ratio (HR)
param Value
0.88
statistical Comment
Stratified log-rank test by performance status and histology.
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
80
ci Upper Limit
1.17
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.28
p Value Comment
1-sided p-value
param Type
Hazard Ratio (HR)
param Value
0.88
statistical Comment
Stratified log-rank test by performance status and histology.
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
7.7
upper Limit
13.5
value
10
group Id
OG001
lower Limit
6.6
upper Limit
13.8
value
8.5

denoms

counts
group Id
OG000
value
45
group Id
OG001
value
47
units
Participants

description

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

dispersion Type

95% Confidence Interval

groups

description
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
id
OG000
title
Phase II Cisplatin-pemetrexed Cediranib 20mg
description
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
id
OG001
title
Phase II Cisplatin-pemetrexed Placebo

param Type

MEDIAN

population Description

Only eligible and analyzable patients are included in the analysis.

reporting Status

POSTED

time Frame

From date of registration to death.Disease assessment will be repeated every 6 weeks until disease progression. After progression, follow up will occur every 6 months for the first two years and then at the end of the third year after registration.

title

Overall Survival (Phase II)

type

SECONDARY

unit Of Measure

month

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Preserved source evidence · Not medical advice