CHAPEL HILL, N.C. - A clinical trial at the University of North Carolina at Chapel Hill is testing the effectiveness of a new drug for treating cancers of the ovaries and endometrium, the lining of the uterus.
The study, sponsored by Eli Lilly and Company of Indianapolis, is the only one in North Carolina to test this latest selective estrogen receptor modulator (SERM), known by its investigational number LY353381. Unlike traditional chemotherapy, side effects associated with the drug are minimal. Moreover, the drug is given orally rather than administered through intravenous infusion.
"Traditional chemotherapy is usually cytotoxic; it kills cells. And when it kills cancer cells, it kills some of your healthy cells," says Dr. Linda Van Le, associate professor of obstetrics and gynecology at UNC-CH School of Medicine and member of the UNC Lineberger Comprehensive Cancer Center. "And side effects associated with traditional chemotherapy can include hair loss and decrease in white blood cell count. When white cell count is decreased, a major concern is an increased risk of infection."
According to Van Le, LY353381 does not have these side effects. However, there may be hot flashes and an increased risk of deep venous thrombosis, formation of blood clots in veins. "But otherwise it's an oral pill with hardly any side effects."
The UNC gynecologic oncologist explains that in endometrial and ovarian cancers the drug specifically targets estrogen cell receptor sites in uterine and ovarian tissue. In doing so, this "designer estrogen" would block estrogen uptake of ovarian and endometrial tumors, thus inhibiting their growth.
At the same time, the drug may offer additional benefits. Anti-estrogenic effects in the uterus and ovaries have been shown experimentally, and LY353381 also acts like estrogen to help protect against bone loss and to lower cholesterol, which is of particular value to older women.
"This 3rd generation SERM has been modulated to increase its ability to bind to estrogen receptors probably about 10-fold more than what is currently available," Van Le says.
Ovarian cancer is the most lethal gynecological cancer. It accounts for 40% of all cancers among women and ranks second among gynecological cancers. According to the American Cancer Society, 25,200 women will be diagnosed with the disease this year. An estimated 14,500 will die from it. As to endometrial cancer, about 37,000 new cases will be diagnosed this year, with an expected 6,400 deaths.
The ongoing LY353381 clinical trial at UNC continues to enroll new patients. Women interested in entering the study should contact Dr. Van Le at 919-966-5996.
"I'm very hopeful that this will offer a different approach to these cancers," she says.
Note to media: Contact Dr. Linda Van Le at 919-966-5996; E-mail: LVL@med.unc.edu