Recruiting
Phase 2

Paclitaxel, Carboplatin, Metformin

Sponsor:

Gynecologic Oncology Associates

Code:

NCT02437812

Conditions

Epithelial Ovarian Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metformin

Paclitaxel

Carboplatin

Study Details

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.

Conditions

Epithelial Ovarian Carcinoma

Study ID

NCT02437812

Start date

Jan, 2014

Status verified date

Aug, 2016

Completion date

Apr, 2021

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Paclitaxel, carboplatin and 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.

Interventions

Metformin

Metformin with standard chemotherapy

Paclitaxel

Standard chemotherapy

Carboplatin

Standard chemotherapy

Primary outcome measure

  • Progression free survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

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

949-642-1361Research@gynoncology.com

Katrina Lopez, CCRC

949-642-5165Katrinal@gynoncology.com

Locations

Gynecologic Oncology Associates

Recruiting

Newport Beach, California, United States, 92663

Contacts

Katrina Lopez, CCRC

949-642-5165Katrinal@gynoncology.com

More Information

Sponsor

Gynecologic Oncology Associates

Last update posted

Feb 28, 2017

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gynecologic Oncology Associates on 2017-02-28.