Yale Clinical Trial Tests New Approach for Treatment of Women with Ovarian Cancer

Yale School of Medicine researchers are testing a promising new treatment for women with recurrent ovarian cancer, which is the fourth leading cause of cancer-related deaths in women in the United States, affecting one in 100 women.

The women will be administered Phenoxodiol, a drug known to unblock death receptors vital to the destruction of cancer cells. The Phase Two clinical trial is taking place at sites around the world, and Yale School of Medicine is the only U.S. site participating in the trial.

A Phase Two trial is designed to determine the efficacy of a drug that already was proven non-toxic in its Phase One stage. In a Phase Two trial, people who have the disease that is being studied are given the drug to test if it has any effect on the disease.

“This is a completely new approach in the treatment of ovarian cancer,” said Gil Mor, M.D., associate professor of obstetrics and gynecology who, along with Thomas Rutherford, M.D., associate professor of gynecologic oncology, will lead the trial at Yale. “We are finding that phenoxodiol is able to induce cell death in ovarian cancer cells that proved to be resistant to the effects of all other drugs, including those presently in use for the treatment of ovarian cancer. We have good evidence as to why this is happening, and we look forward to seeing the drug tested in women with this difficult form of cancer.”

About 40 women will be enrolled in the trial initially. Patients will receive Phenoxodiol by intravenous injection on two consecutive days per week for a treatment cycle lasting 12 weeks. The researchers will be monitoring the drug’s effect on tumor mass, tumor markers and one-year survival.

Phenoxodiol will be assessed for its ability to halt the growth or to shrink tumors in women with ovarian or fallopian cancer who have failed other forms of standard chemotherapy. Phenoxodiol will be the only anti-cancer drug to be used in these women.

“In Yale laboratories, we could not find another compound as promising as phenoxodiol for this form of cancer,” said Rutherford. “We look forward to seeing how phenoxodiol will work in our patients.”

Ovarian cancer, which includes cancer of the fallopian tubes, is the leading cause of cancer death from gynecologic malignancies. In 2002, it is estimated that 23,300 new cases will be diagnosed in the United States and 13,900 deaths will occur.

The high mortality is largely related to the absence of early symptoms and consequently late detection. About 80 percent of patients are diagnosed in advanced stages of the disease. Even in properly diagnosed patients with stage I or II disease, the five year survival ranges from 50 percent to 90 percent, depending on the degree of tumor differentiation. Patients will respond to initial chemotherapy in 80 to 90 percent of cases, yet less than 10 to 15 percent will remain in remission. Advances in treatment have led to improved five-year survival, approaching 45 percent, however there have been no advances made in overall survival.

The drug is being tested by Yale for Marshall Edwards, Inc., a subsidiary of Novogen Ltd.

Women interested in participating in the trial should contact Renee Luongo at 203-737-5225.

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