Pharmaceutical company Marshall Edwards has announced plans for a Phase Ib/IIa clinical study of the investigational anticancer drug, phenoxodiol in combination with docetaxel for women with recurrent ovarian cancer. The clinical study will take place at the Yale University School of Medicine and is supported jointly by sanofi-aventis and Marshall Edwards.
Docetaxel is a second-generation taxane that is commonly used in patients with recurrent or persistent ovarian cancer that have failed other therapies, including the first-generation taxane, paclitaxel. 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 in patients with measurable disease, and on the basis of tumor marker levels in patients with non-measurable disease.