Phase II Study of Mifepristone (RU-486) in the Treatment of PR Positive Advanced/Recurrent Endometrioid Adenocarcinoma and Low Grade Endometrial Stromal Sarcoma (LGESS)
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Overall Response
Overall Response = Complete and Partial Responses
With each 4 week cycle, follow up 2 years
No
Lois M. Ramondetta, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
ID01-212
NCT00505739
September 2001
May 2008
Name | Location |
---|---|
U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |