CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 469 enrolled
Drug / intervention
Carboplatin +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02065687
NCT02065687Phase 3Unknown

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

Gynecologic Oncology Group·interventional·Posted Feb 19, 2014·Updated Sep 30, 2021

In Brief

A Phase 3 clinical trial evaluating Carboplatin, Laboratory Biomarker Analysis, and 5 other interventions for Endometrial Adenocarcinoma and 11 related conditions. Targeting 469 participants across 431 sites.

Detailed Summary

This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.

Study Details

Timeline

Phase 3UnknownOverdue
2014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2014
Enrollment StartMar 17, 2014
Primary CompletionApr 17, 2019
Study CompletionSep 13, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 12.4 years ago

Interventions

Carboplatindrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Metformin Hydrochloridedrug

Given PO

Paclitaxeldrug

Given IV

Placebo Administrationother

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies