Mifepristone for Patients With Endometrial Cancer and LGESS

NCT00505739 | Completed Phase 2

• 1 other identifier: ID01-212
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 2.To evaluate the quantitative and qualitative toxicities of Mifepristone in this patient population.
3. 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. 4.To evaluate the effect of the agent and dosing schedule on the patient's quality of life.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Low Grade Endometrial Stromal Sarcoma; RU-486; Mifepristone; LGESS

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Overall Response

  Overall Response = Complete and Partial Responses

  With each 4 week cycle, follow up 2 years

Study Arms (1)

Mifepristone

EXPERIMENTAL

Drug: Mifepristone

Interventions

Mifepristone DRUG

200 mg by mouth (PO) Daily x 4 Weeks

Also known as: RU-486

Mifepristone

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of advanced/recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS) not amenable to curative surgery or radiotherapy.
• 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.
• 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.
• 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.
• Performance status \< Zubrod 2.
• Estimated life expectancy of at least 12 weeks.
• Prior chemotherapy for recurrent or metastatic endometrial cancer is permitted.
• 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.
• Adequate bone marrow reserve: granulocyte count \> 1.5 x 109/L, hemoglobin \> 9 g/dL (transfusion-independent) and platelets \> 100,000 K/UL.
• 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.
• Patient compliance and geographic proximity that allows adequate follow-up.
• Signed informed consent.

You may not qualify if:

• Patients with serous or clear cell carcinomas of the endometrium.
• Patients whose tumor is known to be PR negative.
• Uncontrolled hypercalcemia.
• Patients taking phenytoin, phenobarbital or carbamazepine.
• Known predisposition to thromboembolic disorder, which in the investigator's judgment would put the patient at unacceptable risk for thromboembolic complications.
• 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.
• 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.
• 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.
• Use of any chemotherapy or investigational agent within 3 weeks prior to taking study drug.
• Concurrent serious infection.
• Patients with serious intercurrent medical illness.
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• Patients whom absorption of drugs is likely to be impaired due to either concomitant medications or prior surgery.
• Overt psychosis or mental disability or otherwise incompetent to give informed consent.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Stromal Tumors

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lois M. Ramondetta, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 23, 2007
• Study Start: September 1, 2001
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2008
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)