CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Metformindrug
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/NCT01579812
NCT01579812Phase 2Completed
CompareCT.gov

A Phase II Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

University of Michigan Rogel Cancer Center·interventional·Posted Apr 18, 2012·Updated May 25, 2018

In Brief

A Phase 2 clinical trial evaluating Metformin for Ovarian, Fallopian Tube, and Primary Peritoneal Cancer. Completed, enrolled 90 participants across 1 site.

Detailed Summary

The primary objective of this study is to determine if metformin administered in combination with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer will improve recurrence-free survival at 18 months compared to controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian, Fallopian Tube, and Primary Peritoneal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 18, 2012
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.2 years ago

Interventions

Metformindrug

Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy. Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.