Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00505739
Other study ID # ID01-212
Secondary ID
Status Completed
Phase Phase 2
First received July 19, 2007
Last updated July 26, 2012
Start date September 2001
Est. completion date May 2008

Study information

Verified date July 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date May 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Mifepristone
200 mg by mouth (PO) Daily x 4 Weeks

Locations

Country Name City State
United States U.T.M.D. Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients with Overall Response Overall Response = Complete and Partial Responses With each 4 week cycle, follow up 2 years No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05796518 - Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors N/A
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06463028 - Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer Phase 2
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Completed NCT03820024 - MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback N/A
Active, not recruiting NCT05082025 - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations Phase 2
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer
Completed NCT05378152 - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity N/A
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Recruiting NCT04569773 - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Not yet recruiting NCT06366347 - ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab Phase 2
Not yet recruiting NCT06073184 - Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium Phase 2
Not yet recruiting NCT05998798 - Revealing Engagement Patterns Among Endometrial Cancer Patients
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Completed NCT02413606 - ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? N/A