Check candidates for mifepristone trial
Women who wish to participate in the mifepristone trial at the University of Texas M.D. Anderson Cancer Center must fit the following criteria:
- must have a diagnosis of advanced or recurrent endometrioid adenocarcinoma or low-grade endometrial stromal sarcoma (LGESS);
- should have had a minimum of a total abdominal hysterectomy and bilateral salpingoophorectomy (removal of uterus, ovaries and fallopian tubes), or definitive radiation therapy;
- the recurrent tumor must be progesterone receptor (PR) positive;
- prior chemotherapy for recurrent or metastatic endometrial cancer or LGESS is permitted;
- must have measurable disease by X-ray or physical examination;
- must be able to return to M.D. Anderson periodically for follow-up;
- should not be on medications to control seizure activity;
- if taking estrogen, progestin, or antiprogestins, must discontinue their use at least three weeks prior to beginning treatment with mifepristone;
- should not have a history of another malignancy other than nonmelanoma skin cancer, unless they are in complete remission and have not been on therapy for that disease for a minimum of five years;
- should not have another serious medical illness.
Patients will undergo a physical exam and laboratory work once a month. At the end of eight weeks, a computed tomography scan will be done to see if mifepristone is helping shrink endometrial tumors. Participants with stable disease or improvement may take the drug for as long as it benefits them. Patients who experience significant side effects may have treatment interrupted until the side effects resolve.
Study participants are responsible for the cost of the trial drug. Women are advised to check with their health insurance carrier for possible coverage.
For more information or to register for the trials, contact Jacalyn Gano, RN, telephone (713) 794-1422, or e-mail [email protected]. Further information on the trial is available at the following web site: www.mdanderson.org/mifepristone.
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