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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02437812
• Other study ID #: GOA-TCOM1
• Status: Recruiting
• Phase: Phase 2
• First received: April 21, 2015
• Last updated: February 24, 2017
• Start date: January 2014
• Est. completion date: April 2021

Study information

• Verified date: August 2016
• Source: Gynecologic Oncology Associates
• Contact: Lisa N Abaid, M.D., M.P.H.
• Phone: 949-642-1361
• Email: Research[@]gynoncology.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2021
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Metformin
Metformin with standard chemotherapy
• Paclitaxel
Standard chemotherapy
• Carboplatin
Standard chemotherapy

Locations

Country	Name	City	State
United States	Gynecologic Oncology Associates	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Associates	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Secondary	Metabolic biomarker evaluation	Glucose (mg/dL)	3 months
Secondary	Metabolic biomarker evaluation	Fasting insulin (mIU/L)	3 months
Secondary	Metabolic biomarker evaluation	BMI (kg/m2)	3 months
Secondary	Metabolic biomarker evaluation	Urine (mOsm/kg)	3 months