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 Bae-Jump, MD
Status
Terminated
Date Opened To Accrual
March 17 2014
Date Closed to Accrual
February 01 2018
Date of Study Termination
April 01 2025
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.