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

Phase 2

• Conditions: Epithelial Ovarian Carcinoma
• Interventions: Drug: Metformin; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT02437812
• Lead Sponsor: Gynecologic Oncology Associates

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Status Verified: 2016-08
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28
• Primary Completion: 2017-10
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel, carboplatin and metformin	Carboplatin	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.
Paclitaxel, carboplatin and metformin	Metformin	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.
Paclitaxel, carboplatin and metformin	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Metabolic biomarker evaluation	3 months	Urine (mOsm/kg)

Trial Locations

Locations (1)

Gynecologic Oncology Associates; 🇺🇸 Newport Beach, California, United States