PHILADELPHIA (December 17, 1999)-Fox Chase Cancer Center is offering a new prevention study for women at increased risk of ovarian cancer. Women who have decided to have their ovaries removed may be eligible to take part in this clinical trial of cancer chemoprevention-the use of natural or man-made agents to prevent cancer.
The study uses a medicine, fenretinide, related to vitamin A. Past clinical studies have tested this drug as preventive medicine for cancers of the head and neck and breast cancer.
The goals of the new study are to determine whether fenretinide can stop the development of ovarian cancer, to identify biological markers for the disease in high-risk women and to evaluate the effects of fenretinide treatment at the molecular level.
Women who enroll will be assigned to receive either fenretinide or an inactive compound called a placebo. They will take the medication for four to six months before their elective surgery to remove the ovaries, a procedure known as prophylactic oophorectomy. After the surgery, researchers will examine the effects on molecular changes in ovarian tissue to see if fenretinide makes a difference compared to the placebo.
Medical oncologist Dr. Christine E. Szarka directs the study. She is working in collaboration with gynecologic oncologists and staff of the Margaret Dyson Family-Risk Assessment Program at Fox Chase.
A woman may enroll in the study if she has chosen to have her ovaries removed to reduce her risk of ovarian cancer because:
- she tested positive for one of two breast-cancer genes, BRCA1 or BRCA2, which also increase the risk of ovarian cancer;
- she has one or more first-degree relatives-mother or sisters-who developed ovarian cancer before age 50;
- her family history includes one first-degree relative diagnosed with ovarian cancer at any age and one or more first-degree and second-degree relatives, such as aunts and first cousins, diagnosed with breast cancer at any age.
Many breast cancer patients have an increased risk of ovarian cancer because some of the same genetic changes are involved in both cancers. A previous study used fenretinide as follow-up treatment for women with early breast cancer to help prevent cancer from developing in the other breast. One group of patients took fenretinide for five years while a comparable group did not. None of the women taking the drug developed cancer of the ovary, but six of the comparison group did.
Past research has also shown that oophorectomy alone may not be enough to protect some women at high risk of ovarian cancer. Even after removal of the ovaries, a few women have gone on to develop cancer in the abdominal lining-apparently because these abdominal cells are similar to the cells that develop cancer on the surface of the ovary.
The Department of Defense is funding the new Fox Chase study. Additional support comes from the National Cancer Institute, which will provide the medication free of charge.
The primary side effect of fenretinide is a mild to moderate reduction in nighttime vision experienced by about 50 percent of those taking the drug. Since a monthly three-day "drug holiday" prevents this condition, women in the trial will be asked to stop taking the medicine for three consecutive days each month.
All women in the trial will receive close medical follow-up during and after the treatment period. For more information about enrolling, call 1-800-ENROLL ME (1-800-367-6556).
Fox Chase Cancer Center is one of 37 National Cancer Institute-designated comprehensive cancer centers in the nation. The Center's activities include basic and clinical research; prevention, detection and treatment of cancer; and community outreach programs.