TriangleNCT02122185 · 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
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.
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 from randomization to death.
Grade 3 or higher serious adverse event. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Reported safety
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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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-recurrent-malignant-germ-cell-tumor
- 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