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

Gynecologic Oncology Associates

Status and phase: Unknown; Phase 2

Conditions: Epithelial Ovarian Carcinoma

Treatments: Drug: Paclitaxel; Drug: Metformin; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02437812

GOA-TCOM1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Paclitaxel, carboplatin and metformin

Experimental group

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.

Treatment:

Drug: Carboplatin

Drug: Metformin

Drug: Paclitaxel