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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00505739 |
Purpose
Primary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: Mifepristone |
Phase II |
| Study Type: | Interventional |
| 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) |
| Enrollment: | 13 |
| Study Start Date: | September 2001 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Mifepristone |
Drug: Mifepristone
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Lois M. Ramondetta, MD/Associate Professor, U.T.M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00505739 History of Changes |
| Other Study ID Numbers: | ID01-212 |
| Study First Received: | July 19, 2007 |
| Last Updated: | March 29, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Endometrial Cancer Low Grade Endometrial Stromal Sarcoma RU-486 Mifepristone LGESS |
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Carcinoma, Endometrioid Endometrial Stromal Tumors Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Ovarian Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Mifepristone Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |