CompletedPhase 2

Mifepristone for Patients With Endometrial Cancer and LGESS

United States13 participantsStarted 2001-09

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologic diagnosis of advanced/recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS) not amenable to curative surgery or radiotherapy.
. Patients should have previously undergone radical surgery (minimum of total abdominal hysterectomy and bilateral salpingoophorectomy) definitive radiation therapy, or not be candidates for such procedures.
. The primary (including archived specimens) or recurrent tumor must be PR positive. Hormone receptor positivity is defined as PR positivity in \>/+10% cells by immunohistochemistry.
. Prior radiotherapy must have been completed at least 2 weeks prior to the initiation of Mifepristone and patients must have recovered from the acute side effects of such treatment.
. Performance status \< Zubrod 2.
. Estimated life expectancy of at least 12 weeks.
. Prior chemotherapy for recurrent or metastatic endometrial cancer is permitted.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients with Overall Response

Timeframe: With each 4 week cycle, follow up 2 years

Trial details

NCT IDNCT00505739

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-10

View on ClinicalTrials.gov More Endometrial Cancer trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologic diagnosis of advanced/recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS) not amenable to curative surgery or radiotherapy.
. Patients should have previously undergone radical surgery (minimum of total abdominal hysterectomy and bilateral salpingoophorectomy) definitive radiation therapy, or not be candidates for such procedures.
. The primary (including archived specimens) or recurrent tumor must be PR positive. Hormone receptor positivity is defined as PR positivity in \>/+10% cells by immunohistochemistry.
. Prior radiotherapy must have been completed at least 2 weeks prior to the initiation of Mifepristone and patients must have recovered from the acute side effects of such treatment.
. Performance status \< Zubrod 2.
. Estimated life expectancy of at least 12 weeks.
. Prior chemotherapy for recurrent or metastatic endometrial cancer is permitted.

Mifepristone for Patients With Endometrial Cancer and LGESS

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Mifepristone for Patients With Endometrial Cancer and LGESS

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria