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Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer

NCT00729586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2019-07-23

Study results available
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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.

Conditions

  • Endometrial Carcinoma
  • Recurrent Uterine Corpus Carcinoma
  • Stage IIIA Uterine Corpus Cancer
  • Stage IIIB Uterine Corpus Cancer
  • Stage IIIC1 Uterine Corpus Cancer
  • Stage IIIC2 Uterine Corpus Cancer
  • Stage IVA Uterine Corpus Cancer
  • Stage IVB Uterine Corpus Cancer

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Megestrol Acetate

Given PO

DRUG

Tamoxifen Citrate

Given PO

DRUG

Temsirolimus

Given IV

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Gini Fleming · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729586 on ClinicalTrials.gov