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Clinical Trials

Topic   Cancer - Gynecologic Cancer
Title   GOG0286B: 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
Summary   The aim of this study is 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.
Description   Patients will be randomized to one of two possible treatment arms. Patients in both arms will be treated with the standard of care Paclitaxel IV and Carboplatin IV every 21 days for 6 cycles plus oral Metformin or placebo. The oral study drug Metformin/Placebo will start at 850 mg oral daily, beginning on day 1. If tolerated for 4 weeks, the dose will be increased to 850 mg BID.
IRB Number   14032
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following: patients must be at least 18 years or older and have measurable Stage III, measurable Stage IVA, Stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma. Patients must NOT have received prior chemotherapy or targeted therapy
Status   Open
Start Date   10/09/2014
Principal Name   Eva Chalas, MD
Contact Name   Christina Egan, RN
Email   CEgan@NYUWinthrop.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1216
Alternate Phone   516-663-8391