A Phase 2 interventional study of Metformin and Paclitaxel in Epithelial Ovarian Carcinoma, sponsored by Gynecologic Oncology Associates. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by Gynecologic Oncology Associates · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Gynecologic Oncology Associates is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female Gender
Age greater than 18 years
Advanced stage epithelial ovarian, fallopian tube, or primary peritoneal cancer
Adequate bone marrow function
ECOG performance score of 2 or greater
Patients must be able to swallow oral medication.
Exclusion Criteria:
Subjects must NOT be taking metformin or have been on metformin in the past 6 months.
Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas)
Subjects with concomitant malignancy or a previous malignancy within the past three years, melanoma skin cancer excepted
Drug: Metformin (850 mg) Drug: Carboplatin (AUC 5 or 6) Drug: Paclitaxel (80 mg/m2) The regimen will be administered as a dose dense schedule.
Drug: Metformin · Drug: Paclitaxel · Drug: Carboplatin
Metformin with standard chemotherapy
Also known as: Glucophage
Standard chemotherapy
Also known as: Taxol
Standard chemotherapy
Also known as: Carbo
Progression 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
Plan to share: Yes — Data will be shared once all data is reviewed
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Associates