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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00505739 |
Primary Objectives:
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: Mifepristone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 37 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Mifepristone
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Drug: Mifepristone
200 mg PO Daily x 4 Weeks
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Lois M. Ramondetta, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Lois M. Ramondetta, MD/Associate Professor ) |
Study ID Numbers: | ID01-212 |
Study First Received: | July 19, 2007 |
Last Updated: | January 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00505739 |
Health Authority: | United States: Institutional Review Board |
Endometrial Cancer Low Grade Endometrial Stromal Sarcoma RU-486 Mifepristone LGESS |
Sarcoma, Endometrial Stromal Gonadal Disorders Malignant mesenchymal tumor Urogenital Neoplasms Ovarian Diseases Carcinoma, Endometrioid Soft tissue sarcomas Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Uterine Neoplasms Endometrial cancer Ovarian cancer |
Ovarian Neoplasms Endometrial stromal sarcoma Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Mifepristone Endometrial Stromal Tumors Recurrence Carcinoma Sarcoma Endocrinopathy Adenocarcinoma Neoplasms, Glandular and Epithelial |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Neoplasms by Histologic Type Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents Luteolytic Agents |
Contraceptives, Postcoital Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic Neoplasms, Complex and Mixed |