Clinical trial · Interventional
Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients
A Phase II Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
NCT01579812CI-TRIAL-00033088completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to determine if metformin administered in combination with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer will improve recurrence-free survival at 18 months compared to controls.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian, Fallopian Tube, and Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Recurrence-Free Survival
- timeFrame
- 18 months
- description
- Determine the percentage of patients alive without recurrence at 18 months. Investigators will also determine recurrence free survival when patients with persistent disease are excluded. Definition of progression or recurrence and survival will be defined as increasing clinical, radiological or histological evidence of disease since study entry or two serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN) performed at least one week apart, regardless of CT scan results. Recurrence-Free Interval will be defined as date from start of chemotherapy to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause.
Secondary outcomes (1)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with potential diagnosis of ovarian, fallopian, or primary peritoneal cancer. 2. Care plan including surgical debulking and traditional adjuvant or neo-adjuvant chemotherapy (6-9 cycles of platinum and taxane based therapy). 3. Eastern Cooperative Oncology Group performance status 0-2. 4. Age \> 18 years or \< 80 years. 5. Adequate renal function (serum creatinine \<1.4mg/dL). 6. Adequate liver function (bilirubin \< 1.5 times ULN). * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \< 5 times the upper limit of normal in case of liver metastases. * ALT or AST \< 2.5 times the ULN in absence of liver metastases. 7. Ability to understand and complete written informed consent. 8. Mentally, physically, and geographically able to undergo treatment and follow up. Exclusion Criteria: 1. Patients diabetes mellitus. (Patients with only a history of gestational diabetes will be allowed to be included in the study.) 2. Metformin use in the last 6 months. 3. A known hypersensitivity to metformin. 4. A history of metabolic acidosis, including ketoacidosis or increased risk of lactic acidosis. 5. Pregnancy or Lactation. 6. Patients who have any severe and/or uncontrolled medical conditions. 7. Patients with a history of renal disease. 8. Patients with other known active malignancy (excluding adequately treated basal cell / squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease free for 2 years). 9. Patients receiving any other investigational agents.
References
Publications (1)
- DERIVEDBrown JR, Chan DK, Shank JJ, Griffith KA, Fan H, Szulawski R, Yang K, Reynolds RK, Johnston C, McLean K, Uppal S, Liu JR, Cabrera L, Taylor SE, Orr BC, Modugno F, Mehta P, Bregenzer M, Mehta G, Shen H, Coffman LG, Buckanovich RJ. Phase II clinical trial of metformin as a cancer stem cell-targeting agent in ovarian cancer. JCI Insight. 2020 Jun 4;5(11):e133247. doi: 10.1172/jci.insight.133247. PMID 32369446