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Major ovarian cancer clinical study announced at Yale using combination drug therapy

A clinical study of ovarian cancer initiated by investigators at Yale School of Medicine will combine the anti-cancer drug phenoxodiol with docetaxel for women with recurrent ovarian cancer.

"Advanced-stage ovarian cancer is one of the most devastating forms of cancer, with half of the women diagnosed with it dying within five years," said principal investigator Thomas Rutherford, M.D., associate professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale and a member of the Yale Cancer Center. "One of the imperatives facing doctors who treat these patients is to find ways to restore sensitivity to drugs such as taxanes once they start to lose that sensitivity."

The Phase Ib/IIa clinical study is supported by Sanofi-Aventis and Marshall Edwards, Inc. It will combine phenoxodiol, which is in the investigational phase with docetaxel, a second-generation taxane--drug that inhibits cell growth by stopping cell division--commonly used in patients with recurrent or persistent ovarian cancer that has failed other therapies, including the first generation taxane paclitaxel. The clinical response rate to any chemotherapeutic is often limited due to rapid development of chemo-resistance in women with recurrent ovarian cancer.

The purpose of the study is to determine if the addition of phenoxodiol to docetaxel can improve clinical response and survival by delaying or preventing the development of chemo-resistance in women with recurrent ovarian cancer.

The study will enroll 60 women with recurrent epithelial ovarian, fallopian tube or abdominal cavity cancer after treatment with a platinum and paclitaxel. All 60 patients will be given docetaxel by injection weekly; half the patients will also be given oral phenoxodiol daily, and the other half a placebo tablet. Tumor response will be determined on the basis of tumor burden (RECIST criteria) in patients with measurable disease, and tumor marker levels (GCIG criteria
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Contact: Karen N. Peart
karen.peart@yale.edu
203-432-1326
Yale University
28-Nov-2005


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