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Mifepristone for Patients With Endometrial Cancer and LGESS

NCT00505739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-07-30

No results posted yet for this study

Summary

Primary Objectives:

1. To determine the antitumor activity of Mifepristone (RU-486) in patients with advanced or recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS).
2. To evaluate the quantitative and qualitative toxicities of Mifepristone in this patient population.
3. To evaluate at a tissue level the effect of Mifepristone on estrogen and progesterone receptors post treatment and to evaluate other markers that may reflect effects of Mifepristone on cancer cell growth.
4. To evaluate the effect of the agent and dosing schedule on the patient's quality of life.

Conditions

Interventions

DRUG

Mifepristone

200 mg by mouth (PO) Daily x 4 Weeks

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lois M. Ramondetta, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2007-10-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00505739 on ClinicalTrials.gov