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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 History of Changes |
Health Authority: | United States: Institutional Review Board |
Endometrial Cancer Low Grade Endometrial Stromal Sarcoma RU-486 Mifepristone LGESS |
Sarcoma, Endometrial Stromal Contraceptive Agents Gonadal Disorders Hormone Antagonists Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Urogenital Neoplasms Endometrial Cancer Ovarian Diseases Hormones Carcinoma, Endometrioid Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms |
Soft Tissue Sarcomas Uterine Neoplasms Ovarian Cancer Endometrial Stromal Sarcoma Ovarian Neoplasms Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Mifepristone Contraceptives, Postcoital Endometrial Stromal Tumors Recurrence Carcinoma Malignant Mesenchymal Tumor Sarcoma |
Contraceptives, Postcoital, Synthetic Sarcoma, Endometrial Stromal Contraceptive Agents Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Urogenital Neoplasms Reproductive Control Agents Ovarian Diseases Carcinoma, Endometrioid Genital Diseases, Female Neoplasms, Connective and Soft Tissue |
Endometrial Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Uterine Neoplasms Contraceptives, Oral, Synthetic Abortifacient Agents, Steroidal Neoplasms by Histologic Type Ovarian Neoplasms Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Mifepristone Luteolytic Agents |