Mifepristone for Patients With Endometrial Cancer and LGESS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505739
First received: July 19, 2007
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

Primary Objectives:

  1. To determine the antitumor activity of Mifepristone (RU-486) in patients with advanced or recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS).
  2. To evaluate the quantitative and qualitative toxicities of Mifepristone in this patient population.
  3. 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.
  4. To evaluate the effect of the agent and dosing schedule on the patient's quality of life.

Condition Intervention Phase
Endometrial Cancer
Drug: Mifepristone
Phase 2

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)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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


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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic diagnosis of advanced/recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS) not amenable to curative surgery or radiotherapy.
  2. Patients should have previously undergone radical surgery (minimum of total abdominal hysterectomy and bilateral salpingoophorectomy) definitive radiation therapy, or not be candidates for such procedures.
  3. The primary (including archived specimens) or recurrent tumor must be PR positive. Hormone receptor positivity is defined as PR positivity in >/+10% cells by immunohistochemistry.
  4. Prior radiotherapy must have been completed at least 2 weeks prior to the initiation of Mifepristone and patients must have recovered from the acute side effects of such treatment.
  5. Performance status < Zubrod 2.
  6. Estimated life expectancy of at least 12 weeks.
  7. Prior chemotherapy for recurrent or metastatic endometrial cancer is permitted.
  8. Patients must have measurable disease as defined by the presence of bidimensionally measurable lesions with clearly defined margins on x-ray, scan (CT or MRI) or physical exam.
  9. Adequate bone marrow reserve: granulocyte count > 1.5 x 109/L, hemoglobin > 9 g/dL (transfusion-independent) and platelets > 100,000 K/UL.
  10. Adequate liver and renal function as defined as: total bilirubin value < 1.5 mg/dL; SGPT < 2x the upper limit of normal or < 5x the upper limit of normal when liver metastases are present; serum creatinine value of < 1.8 mg/dL. All qualifying laboratory parameters must be determined within one week of first treatment.
  11. Patient compliance and geographic proximity that allows adequate follow-up.
  12. Signed informed consent.

Exclusion Criteria:

  1. Patients with serous or clear cell carcinomas of the endometrium.
  2. Patients whose tumor is known to be PR negative.
  3. Uncontrolled hypercalcemia.
  4. Patients taking phenytoin, phenobarbital or carbamazepine.
  5. Known predisposition to thromboembolic disorder, which in the investigator's judgment would put the patient at unacceptable risk for thromboembolic complications.
  6. Patients who have received treatment for brain metastases may be enrolled provided they have remained stable for at least 6 months after surgery or radiation.
  7. Women taking estrogen, progestin or antiprogestins. Patients taking these drugs must have discontinued their use at least 3 weeks prior to beginning treatment with Mifepristone.
  8. History of other malignancy (except adequately treated non-melanomatous carcinoma of the skin or cervical carcinoma in situ) unless in complete remission and off all therapy for that disease for a minimum of 5 years.
  9. Use of any chemotherapy or investigational agent within 3 weeks prior to taking study drug.
  10. Concurrent serious infection.
  11. Patients with serious intercurrent medical illness.
  12. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
  13. Patients whom absorption of drugs is likely to be impaired due to either concomitant medications or prior surgery.
  14. Overt psychosis or mental disability or otherwise incompetent to give informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505739

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: 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: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Endometrial Cancer
Low Grade Endometrial Stromal Sarcoma
RU-486
Mifepristone
LGESS

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
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
Neoplasms, Connective Tissue
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014