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Study of effect of metformin in patients with relapsed epithelial ovarian cancer

Phase II study of metformin in patients in biochemical relapse with epithelial ovarian cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/12/006454
Enrollment
25
Registered
2015-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- carcinoma ovary

Interventions

Intervention1: Tab Metformin 500 mg: To assess the response of metformin on CA-125 levels in patients with carcinoma ovary post treatment under followup with rising CA-125 levels. Control Intervention

Sponsors

Cancer Institute WIA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient inclusion criteria i. Women with carcinoma of the ovary presenting in first relapse with increasing CA-125 and who are asymptomatic ii. Post menopausal women. Iii. ECOG performance status 0-2. iv. v. Adequate renal function (Serum creatinine vi. Adequate liver function (Serum bilirubin times ULN) vii. Ability to give an informed consent

Exclusion criteria

Exclusion criteria: Patient exclusion criteria i. Patients with diabetes mellitus. ii. Metformin use in the last 6 months. Iii. A known hypersensitivity to Metformin. iv. Patients who have any severe and/or uncontrolled medical conditions. v. Patients with a history of renal disease. vi. Patients with other known active malignancy vii. Patients receiving any other investigational agents

Design outcomes

Primary

MeasureTime frame
Complete response or Partial responseTimepoint: 1 february 2016

Secondary

MeasureTime frame
time gained by metformin to delay true progression.Timepoint: 1 february 2016

Countries

India

Contacts

Public ContactT S Ganesan

Cancer Institute (WIA)

harshatreya@gmail.com9710968920

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026