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

NCT ID: NCT02437812

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2021-04-30

Brief Summary

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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

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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.

Conditions

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Epithelial Ovarian Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin with standard chemotherapy

Paclitaxel

Intervention Type DRUG

Standard chemotherapy

Carboplatin

Intervention Type DRUG

Standard chemotherapy

Interventions

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Metformin

Metformin with standard chemotherapy

Intervention Type DRUG

Paclitaxel

Standard chemotherapy

Intervention Type DRUG

Carboplatin

Standard chemotherapy

Intervention Type DRUG

Other Intervention Names

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Glucophage Taxol Carbo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Gynecologic Oncology Associates

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Associates

Locations

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Gynecologic Oncology Associates

Newport Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

949-642-1361

Katrina Lopez, CCRC

Role: CONTACT

949-642-5165 ext. 259

Facility Contacts

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Katrina Lopez, CCRC

Role: primary

949-642-5165 ext. 259

Other Identifiers

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GOA-TCOM1

Identifier Type: -

Identifier Source: org_study_id

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