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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

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. Secondary Objectives: To estimate the proportion of patients with objective response (RR) in the population of patients with measurable disease by treatment. To estimate the duration of response in the population of patients with measurable disease who respond by treatment. To estimate overall survival (OS) and relative hazards of death for each treatment arm if the study stops after the phase II trial is completed. If the study continues with a phase III clinical trial, then PFS will be a secondary endpoint. To determine the nature, frequency and degree of toxicity as assessed by CTCAE for each treatment arm. To estimate possible differences in RR, PFS, OS, and toxicity rates for the treatment regimens by the patients level of obesity.

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. Secondary Objectives: To estimate the proportion of patients with objective response (RR) in the population of patients with measurable disease by treatment. To estimate the duration of response in the population of patients with measurable disease who respond by treatment. To estimate overall survival (OS) and relative hazards of death for each treatment arm if the study stops after the phase II trial is completed. If the study continues with a phase III clinical trial, then PFS will be a secondary endpoint. To determine the nature, frequency and degree of toxicity as assessed by CTCAE for each treatment arm. To estimate possible differences in RR, PFS, OS, and toxicity rates for the treatment regimens by the patients level of obesity.