Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma

Epithelial Ovarian Carcinoma Clinical Trial

Official title: A Phase II, Open-Label, Non-Randomized, Pilot Study of Paclitaxel, Carboplatin and Oral Metformin for Patients Newly Diagnosed With Stage II-IV Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Carcinoma
• Epithelial Ovarian Carcinoma
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

• NCT number: NCT02437812
• Study type: Interventional
• Source: Gynecologic Oncology Associates
• Contact: Lisa N Abaid, M.D., M.P.H.
• Phone: 949-642-1361
• Email: Research@gynoncology.com
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2014
• Completion date: April 2021