CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Megestrol Acetate +3 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/NCT00729586
NCT00729586Phase 2Completed

A Randomized Phase II Trial of Temsirolimus (NCI-Supplied Agent, NSC # 683864) or the Combination of Hormonal Therapy Plus Temsirolimus in Women With Advanced, Persistent, or Recurrent Endometrial Carcinoma

National Cancer Institute (NCI)·interventional·Posted Aug 7, 2008·Updated Jul 23, 2019

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Megestrol Acetate, and 2 other interventions for Endometrial Carcinoma and 7 related conditions. Completed, enrolled 73 participants across 108 sites.

Detailed Summary

This randomized phase II trial studies how well temsirolimus with or without megestrol acetate and tamoxifen citrate works in treating patients with endometrial cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, or is persistent. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate and tamoxifen citrate may fight endometrial cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether temsirolimus is more effective when given alone or together with megestrol acetate and tamoxifen citrate in treating endometrial cancer.

Study Details

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2008
Enrollment StartSep 1, 2008
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 17.9 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Megestrol Acetatedrug

Given PO

Tamoxifen Citratedrug

Given PO

Temsirolimusdrug

Given IV