Endometrial Cancer Clinical Trial
Official title:
Phase II Study of Mifepristone (RU-486) in the Treatment of PR Positive Advanced/Recurrent Endometrioid Adenocarcinoma and Low Grade Endometrial Stromal Sarcoma (LGESS)
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.
Mifepristone is a drug that has been approved for use in the termination of pregnancy. It
has been studied in women with breast and ovarian cancer.
Before treatment starts, patients will have a complete checkup, blood tests, a CT scan, and
a chest x-ray. Women able to have children must have a negative urine pregnancy test. Blood
tests and a complete checkup will also be done within 3 days of starting each course of
therapy and a month after treatment ends. Tumors will be measured by CT scans once every 2-3
months and at the end of treatment.
Patients in this study will take Mifepristone in the form of a pill by mouth every day. Each
course of therapy is 4 weeks long. Patients will see their doctor for an exam and blood
tests before they begin each 4 week course of therapy. The dose of Mifepristone may be
lowered if the patient has side effects. Patients who have a complete response (there is no
evidence of cancer by physical exam or x-ray) will continue taking Mifepristone for 2 years
after this response is documented. Other patients will take Mifepristone for as long as it
benefits them.
This is an investigational study. At least 12 and as many as 37 patients will take part in
this study. Patients from MD Anderson Cancer Center and Gynecologic Oncology of Houston,
P.A. will be enrolled.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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