NCT02437812

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 28, 2017

Status Verified

August 1, 2016

Enrollment Period

3.8 years

First QC Date

April 21, 2015

Last Update Submit

February 24, 2017

Conditions

Epithelial Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Metabolic biomarker evaluation

    3 months

  • Metabolic biomarker evaluation

    3 months

  • Metabolic biomarker evaluation

    3 months

  • Metabolic biomarker evaluation

    3 months

Study Arms (1)

Paclitaxel, carboplatin and metformin

EXPERIMENTAL

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.

Drug: MetforminDrug: PaclitaxelDrug: Carboplatin

Interventions

MetforminDRUG

Metformin with standard chemotherapy

Also known as: Glucophage
Paclitaxel, carboplatin and metformin
PaclitaxelDRUG

Standard chemotherapy

Also known as: Taxol
Paclitaxel, carboplatin and metformin
CarboplatinDRUG

Standard chemotherapy

Also known as: Carbo
Paclitaxel, carboplatin and metformin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

MetforminPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Lisa N Abaid, M.D., M.P.H.

    Gynecologic Oncology Associates

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa N Abaid, M.D., M.P.H.

CONTACT

949-642-1361Research@gynoncology.com

Katrina Lopez, CCRC

CONTACT

949-642-5165Katrinal@gynoncology.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

May 8, 2015

Study Start

January 1, 2014

Primary Completion

October 1, 2017

Study Completion

April 1, 2021

Last Updated

February 28, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Data will be shared once all data is reviewed

Locations

US(1)