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

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

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02437812

Enrollment

Registered

2015-05-08

Start date

2014-01-31

Completion date

2021-04-30

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Carcinoma

Brief 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.

Detailed 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.

Interventions

DRUGMetformin

Metformin with standard chemotherapy

DRUGPaclitaxel

Standard chemotherapy

DRUGCarboplatin

Standard chemotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression free survival	5 years	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.

Secondary

Measure	Time frame	Description
Metabolic biomarker evaluation	3 months	Glucose (mg/dL)

Countries

United States

Contacts

Primary ContactLisa N Abaid, M.D., M.P.H.

Research@gynoncology.com949-642-1361

Backup ContactKatrina Lopez, CCRC

Katrinal@gynoncology.com949-642-5165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026