Newport Beach, California 92663


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 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


NCT ID:

NCT02437812


Primary Contact:

Principal Investigator
Lisa N Abaid, M.D., M.P.H.
Gynecologic Oncology Associates

Lisa N Abaid, M.D., M.P.H.
Phone: 949-642-1361
Email: Research@gynoncology.com


Backup Contact:

Email: Katrinal@gynoncology.com
Katrina Lopez, CCRC
Phone: 949-642-5165 ext. 259


Location Contact:

Newport Beach, California 92663
United States

Katrina Lopez, CCRC
Phone: 949-642-5165
Email: Katrinal@gynoncology.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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