Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.

All patients

→

primary · POSTED

The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.

All patients.

→

secondary · POSTED

The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI.

Evaluable for response

→

secondary · POSTED

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

Patients who responded

→

secondary · POSTED

The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.

All patients

→

secondary · POSTED

Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.

All patients.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Metabolic Factor Levels

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-endometrial-cancer-keytruda-qlex-1191efca
nct id: NCT02065687
qol key: qol-0008
source section id: NCT02065687-om-0008
source outcome index: 8
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Metabolic Factor Levels
measure definition: Hip-to-waist ratio, diabetes status, hemoglobin A1c, fasting insulin glucose levels, and homeostatic model assessment scores will be assessed for their predictive and prognostic significance. Variables will be analyzed as continuous covariates (or as appropriate with transformations such as the logarithm) with Cox models or logistic regression.
time frame: Up to 5 years
analysis role: exploratory
reporting status: NOT_POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-endometrial-cancer-keytruda-qlex-1191efca
nct id: NCT02065687
trial label: Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0000
source section id
NCT02065687-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS) (Phase II)
endpoint definition
Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
time origin
From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0001
source section id
NCT02065687-om-0001
source outcome index
1
endpoint
Overall Survival (OS) (Phase II and III)
endpoint definition
The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
time origin
From date of study entry to time of death or the date of last contact, assessed up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0002
source section id
NCT02065687-om-0002
source outcome index
2
endpoint
Proportion of Patients Responding to Therapy
endpoint definition
The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI.
time origin
During study treatment, up to 5 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable for response
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0003
source section id
NCT02065687-om-0003
source outcome index
3
endpoint
Duration of Response by Treatment
endpoint definition
Duration of response until disease progression, death, or date last seen among patients who responded.
time origin
From the date of response to disease progression, death, or date last seen assessed up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who responded
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0004
source section id
NCT02065687-om-0004
source outcome index
4
endpoint
Overall Survival (OS) (Phase II)
endpoint definition
The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
time origin
From date of study entry to time of death or the date of last contact, assessed up to 5 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0005
source section id
NCT02065687-om-0005
source outcome index
5
endpoint
Progression Free Survival (PFS) (Phase III)
endpoint definition
Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
time origin
From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0000
arm key
OG000
arm label
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
regimen
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.
analyzed count
234
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0000
arm key
OG001
arm label
Arm II (Paclitaxel, Carboplatin, Placebo)
regimen
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.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0001
arm key
OG000
arm label
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
regimen
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.
analyzed count
234
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0001
arm key
OG001
arm label
Arm II (Paclitaxel, Carboplatin, Placebo)
regimen
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.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0002
arm key
OG000
arm label
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
regimen
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.
analyzed count
164
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0002
arm key
OG001
arm label
Arm II (Paclitaxel, Carboplatin, Placebo)
regimen
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.
analyzed count
171
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0003
arm key
OG000
arm label
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
regimen
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.
analyzed count
101
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0003
arm key
OG001
arm label
Arm II (Paclitaxel, Carboplatin, Placebo)
regimen
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.
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0004
arm key
OG000
arm label
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
regimen
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.
analyzed count
234
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0004
arm key
OG001
arm label
Arm II (Paclitaxel, Carboplatin, Placebo)
regimen
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.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0005
arm key
OG000
arm label
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
regimen
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.
analyzed count
234
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
outcome key
om-0005
arm key
OG001
arm label
Arm II (Paclitaxel, Carboplatin, Placebo)
regimen
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.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02065687-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
harm key
EG000
source section id
NCT02065687-ae
event group key
EG000
event group label
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
serious affected
46
serious at risk
234
other affected
222
other at risk
234
frequency threshold
0
collection period
Patients are followed for the occurrence of adverse events for five years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
harm key
EG001
source section id
NCT02065687-ae
event group key
EG001
event group label
Arm II (Paclitaxel, Carboplatin, Placebo)
serious affected
53
serious at risk
235
other affected
222
other at risk
235
frequency threshold
0
collection period
Patients are followed for the occurrence of adverse events for five years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02065687
qol key
qol-0008
source section id
NCT02065687-om-0008
source outcome index
8
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Metabolic Factor Levels
measure definition
Hip-to-waist ratio, diabetes status, hemoglobin A1c, fasting insulin glucose levels, and homeostatic model assessment scores will be assessed for their predictive and prognostic significance. Variables will be analyzed as continuous covariates (or as appropriate with transformations such as the logarithm) with Cox models or logistic regression.
time frame
Up to 5 years
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice