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

Primary Purpose

Epithelial Ovarian Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Metformin

Paclitaxel

Carboplatin

About this trial

This is an interventional treatment trial for Epithelial Ovarian Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Gynecologic Oncology AssociatesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, carboplatin and metformin

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Metabolic biomarker evaluation

Glucose (mg/dL)

Metabolic biomarker evaluation

Fasting insulin (mIU/L)

Metabolic biomarker evaluation

BMI (kg/m2)

Metabolic biomarker evaluation

Urine (mOsm/kg)

Full Information

NCT ID

NCT02437812

First Posted

April 21, 2015

Last Updated

February 24, 2017

Sponsor

Gynecologic Oncology Associates

Collaborators

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT02437812

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gynecologic Oncology Associates

Collaborators

University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epithelial Ovarian Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel, carboplatin and metformin

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

Metformin with standard chemotherapy

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

Standard chemotherapy

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Carbo

Intervention Description

Standard chemotherapy

Primary Outcome Measure Information:

Title

Progression free survival

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.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Metabolic biomarker evaluation

Description

Glucose (mg/dL)

Time Frame

3 months

Title

Metabolic biomarker evaluation

Description

Fasting insulin (mIU/L)

Time Frame

3 months

Title

Metabolic biomarker evaluation

Description

BMI (kg/m2)

Time Frame

3 months

Title

Metabolic biomarker evaluation

Description

Urine (mOsm/kg)

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

949-642-1361

Research@gynoncology.com

First Name & Middle Initial & Last Name or Official Title & Degree

Katrina Lopez, CCRC

Phone

949-642-5165

Ext

259

Katrinal@gynoncology.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Gynecologic Oncology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gynecologic Oncology Associates

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katrina Lopez, CCRC

Phone

949-642-5165

Ext

259

Katrinal@gynoncology.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be shared once all data is reviewed

Learn more about this trial

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

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