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


Study is Available At:


Original ID:

GOA-TCOM1


NCT ID:

NCT02437812


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Associates


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Lisa N Abaid, M.D., M.P.H.
Principal Investigator
Gynecologic Oncology Associates
Primary Contact:Lisa N Abaid, M.D., M.P.H.
949-642-1361
Research@gynoncology.com
Backup Contact:Katrina Lopez, CCRC
949-642-5165 ext. 259
949-642-5165
Katrinal@gynoncology.com

Study Dates

Start Date:January 2014
Completion Date:April 2021
Completion Type:Anticipated
Primary Completion Date:October 2017
Primary Completion Type:Anticipated
Verification Date:August 2016
Last Changed Date:February 24, 2017
First Received Date:April 21, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Metabolic biomarker evaluation
Time Frame:3 months
Safety Issues:False
Description:Urine (mOsm/kg)
Outcome Type:Secondary Outcome
Measure:Metabolic biomarker evaluation
Time Frame:3 months
Safety Issues:False
Description:BMI (kg/m2)
Outcome Type:Secondary Outcome
Measure:Metabolic biomarker evaluation
Time Frame:3 months
Safety Issues:False
Description:Fasting insulin (mIU/L)
Outcome Type:Secondary Outcome
Measure:Metabolic biomarker evaluation
Time Frame:3 months
Safety Issues:False
Description:Glucose (mg/dL)
Outcome Type:Primary Outcome
Measure:Progression free survival
Time Frame:5 years
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Metformin
Description:Metformin with standard chemotherapy
Arm Name:Paclitaxel, carboplatin and metformin
Other Name:Glucophage
Intervention Type:Drug
Name:Paclitaxel
Description:Standard chemotherapy
Arm Name:Paclitaxel, carboplatin and metformin
Other Name:Taxol
Intervention Type:Drug
Name:Carboplatin
Description:Standard chemotherapy
Arm Name:Paclitaxel, carboplatin and metformin
Other Name:Carbo

Study Arms

Study Arm Type:Experimental
Arm Name:Paclitaxel, carboplatin and metformin
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Associates
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of North Carolina, Chapel Hill

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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