Mifepristone for Patients With Endometrial Cancer and LGESS
- To determine the antitumor activity of Mifepristone (RU-486) in patients with advanced or recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS).
- To evaluate the quantitative and qualitative toxicities of Mifepristone in this patient population.
- 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.
- To evaluate the effect of the agent and dosing schedule on the patient's quality of life.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Number of Patients with Overall Response [ Time Frame: With each 4 week cycle, follow up 2 years ] [ Designated as safety issue: No ]Overall Response = Complete and Partial Responses
|Study Start Date:||September 2001|
|Study Completion Date:||May 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
200 mg by mouth (PO) Daily x 4 Weeks
Other Name: RU-486
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505739
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Lois M. Ramondetta, MD||M.D. Anderson Cancer Center|