Study of effect of metformin in patients with relapsed epithelial ovarian cancer
- Conditions
- Health Condition 1: null- carcinoma ovary
- Registration Number
- CTRI/2015/12/006454
- Lead Sponsor
- Cancer Institute WIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 25
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 <1.4mg/dl)
vi. Adequate liver function (Serum bilirubin < 1.5 times ULN; Serum AST/ALT <5
times ULN)
vii. Ability to give an informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response or Partial responseTimepoint: 1 february 2016
- Secondary Outcome Measures
Name Time Method time gained by metformin to delay true progression.Timepoint: 1 february 2016