Endometrial Cancer Clinical Trial
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)
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 |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | U.T.M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
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 |
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 |