GOG-0286B

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Principal Investigator

Victoria L Bae-Jump

Status

Disease Site

Gynecologic [GY] Uterine Corpus

Phase

II/III

Developmental Therapeutics

Yes

Primary Objective

To determine if the addition of metformin to the standard regimen of carboplatin and paclitaxel  prolongs progression-free survival (PFS) in women with advanced or recurrent endometrial cancer (Phase II). To determine if the addition of metformin to the standard regimen of carboplatin and paclitaxel prolongs overall survival (OS) in the same population if a phase III study is conducted. Both clinical trials (Phase II and III) will utilize OS as a primary endpoint if a phase III trial is opened.

Patient Population

The addition of metformin to the standard regimen of carboplatin and paclitaxel  prolongs progression-free survival (PFS) in women with advanced or recurrent endometrial cancer (Phase II). The addition of metformin to the standard regimen of carboplatin and paclitaxel prolongs overall survival (OS) in the same population if a phase III study is conducted.

Target Accrual

540