Initially, the prospect of metformin as a neoplastic treatment was considered for malignancies of the prostate, colon and pancreas. However, only select clinical studies involving the use of metformin in the treatment of ovarian cancer have documented improved survival rates. Since no first line regimen has demonstrated compelling superiority in the management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin, and metformin is of particular interest given the triplet's prospect for achieving increased synergy without compromising patient tolerability.
A phase II, open-label, non-randomized, pilot study assessing the safety, toxicity, and progression free survival of advanced stage ovarian carcinoma patients who underwent treatment with paclitaxel, carboplatin and metformin. An estimated 30 patients will be required for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Metformin with standard chemotherapy
Standard chemotherapy
Standard chemotherapy
Gynecologic Oncology Associates
Newport Beach, California, United States
RECRUITINGProgression free survival
The primary outcome of progression free survival will compare the percentage of those who have either progressed or died at 1 year with those who were at risk for at least 1 year.
Time frame: 5 years
Metabolic biomarker evaluation
Glucose (mg/dL)
Time frame: 3 months
Metabolic biomarker evaluation
Fasting insulin (mIU/L)
Time frame: 3 months
Metabolic biomarker evaluation
BMI (kg/m2)
Time frame: 3 months
Metabolic biomarker evaluation
Urine (mOsm/kg)
Time frame: 3 months
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