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Tracking Information | |||||
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First Received Date † | July 19, 2007 | ||||
Last Updated Date | January 16, 2008 | ||||
Start Date † | September 2001 | ||||
Current Primary Outcome Measures † |
The goal of this clinical research study is to see if the drug Mifepristone can shrink or slow the growth of endometrial cancer. [ Time Frame: 8 Years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00505739 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
The safety of Mifepristone will also be studied. [ Time Frame: 8 Years ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Mifepristone for Patients With Endometrial Cancer and LGESS | ||||
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) | ||||
Brief Summary | Primary Objectives:
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Endometrial Cancer | ||||
Intervention † | Drug: Mifepristone | ||||
Study Arms / Comparison Groups | Experimental: Mifepristone | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 37 | ||||
Estimated Completion Date | September 2009 | ||||
Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00505739 | ||||
Responsible Party | Lois M. Ramondetta, MD/Associate Professor, U.T.M.D. Anderson Cancer Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | M.D. Anderson Cancer Center | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | January 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |