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A Phase II Trial of Temsirolimus or the Combination of Hormonal Therapy Plus Temsirolimus in Women with Advanced, Persistent, or Recurrent Endometrial Carcinoma
[Protocol 09-019]
- Full Title :
- A RANDOMIZED PHASE II TRIAL OF TEMSIROLIMUS(NCI-SUPPLIED AGENT,NSC #683864, IND# 61010)OR THE COMBINATION OF HORMONAL THERAPY PLUS TEMSIROLIMUS IN WOMEN WITH ADVANCED, PERSISTENT, OR RECURRENT ENDOMETRIAL CARCINOMA (GOG-0248)
- Purpose :
The purpose of this study is to evaluate the effects of two different treatments for advanced, persistent, or recurrent endometrial cancer that cannot be cured by surgery or radiation therapy. The first treatment is temsirolimus alone. The second treatment is the combination of temsirolimus plus megestrol acetate alternating with tamoxifen. Patients will be randomly assigned to receive one of these treatments.
Temsirolimus is approved for the treatment of kidney cancer. It works by inhibiting mTOR, an important regulatory protein in a key signaling pathway that governs cancer cell growth and division.
Megestrol acetate is approved for treating endometrial cancer. It is a hormone that decreases the growth of both normal endometrial cells and some endometrial cancer cells. It is believed that it works by interacting with a protein on endometrial cancer cells called the progesterone receptor.
Tamoxifen is approved for the treatment of breast cancer. Because it causes endometrial cells to make more progesterone receptor, it is hoped that tamoxifen will make megestrol acetate work more effectively.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have advanced (stage III or IV), persistent, or recurrent endometrial cancer that cannot be cured by surgery or radiation therapy.
- At least 4 weeks must have passed since any prior surgery and entry into the study,
- Patients may not have had prior chemotherapy for advanced disease nor any hormonal therapy or biologic therapy for endometrial cancer.
For more information about this study and to inquire about eligibility, please contact Dr. Carol Aghajanian at 212-639-2252.
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