NCT02122185 · STUDY IN CONTEXT

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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 to disease progression or death from any cause. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.

Source null

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secondary · POSTED

CA125 progression determined using GCIG criteria. Radiological progression assessed using RECIST criteria as described above for PFS. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.

Source null

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secondary · POSTED

Time from randomization to death.

Source null

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secondary · POSTED

Grade 3 or higher serious adverse event. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Source null

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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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-clear-cell-adenocarcinoma
nct id: NCT02122185
trial label: Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0000
source section id
NCT02122185-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS)
endpoint definition
Time to disease progression or death from any cause. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
time origin
Up to 6 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0001
source section id
NCT02122185-om-0001
source outcome index
1
endpoint
Time to Biochemical (CA-125) Progression, Radiological Progression, or Death.
endpoint definition
CA125 progression determined using GCIG criteria. Radiological progression assessed using RECIST criteria as described above for PFS. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
time origin
Up to 6 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0002
source section id
NCT02122185-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Time from randomization to death.
time origin
Up to 6 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0003
source section id
NCT02122185-om-0003
source outcome index
3
endpoint
Number of Participants With Adverse Events
endpoint definition
Grade 3 or higher serious adverse event. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
time origin
Up to 6 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0000
arm key
OG000
arm label
Metformin Plus Chemotherapy
regimen
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0000
arm key
OG001
arm label
Placebo Plus Chemotherapy
regimen
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0001
arm key
OG000
arm label
Metformin Plus Chemotherapy
regimen
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0001
arm key
OG001
arm label
Placebo Plus Chemotherapy
regimen
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0002
arm key
OG000
arm label
Metformin Plus Chemotherapy
regimen
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0002
arm key
OG001
arm label
Placebo Plus Chemotherapy
regimen
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0003
arm key
OG000
arm label
Metformin Plus Chemotherapy
regimen
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
outcome key
om-0003
arm key
OG001
arm label
Placebo Plus Chemotherapy
regimen
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02122185-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT02122185
harm key
EG000
source section id
NCT02122185-ae
event group key
EG000
event group label
Metformin Plus Chemotherapy
serious affected
19
serious at risk
54
other affected
52
other at risk
54
frequency threshold
5
collection period
6 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-clear-cell-adenocarcinoma
nct id
NCT02122185
harm key
EG001
source section id
NCT02122185-ae
event group key
EG001
event group label
Placebo Plus Chemotherapy
serious affected
13
serious at risk
54
other affected
54
other at risk
54
frequency threshold
5
collection period
6 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

setting source links

Preserved source evidence · Not medical advice