NCT02065687 · OUTCOME

Duration of Response by Treatment

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer · Source last updated 2021-09-30

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: From the date of response to disease progression, death, or date last seen assessed up to 5 years

What was measured

Duration of response until disease progression, death, or date last seen among patients who responded.

Analysis population: Patients who responded

Groups in this outcome

Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)

Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II (Paclitaxel, Carboplatin, Placebo)

Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 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
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	101
Arm II (Paclitaxel, Carboplatin, Placebo)	103

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)	8.0	Not reported	6.3	9.4	Not reported
Arm II (Paclitaxel, Carboplatin, Placebo)	8.0	Not reported	6.2	10.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
6.3
upper Limit
9.4
value
8.0
group Id
OG001
lower Limit
6.2
upper Limit
10.3
value
8.0

denoms

counts
group Id
OG000
value
101
group Id
OG001
value
103
units
Participants

description

Duration of response until disease progression, death, or date last seen among patients who responded.

dispersion Type

95% Confidence Interval

groups

description
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
description
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
OG001
title
Arm II (Paclitaxel, Carboplatin, Placebo)

param Type

MEDIAN

population Description

Patients who responded

reporting Status

POSTED

time Frame

From the date of response to disease progression, death, or date last seen assessed up to 5 years

title

Duration of Response by Treatment

type

SECONDARY

unit Of Measure

Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice