The investigator-initiated clinical study will take place at the Yale University School of Medicine and will enroll 60 women with recurrent epithelial ovarian, fallopian tube or abdominal cavity cancer after treatment with a platinum and paclitaxel.
All 60 patients in the trial 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 tumor marker levels in patients with non-measurable disease.
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. In this setting, docetaxel faces the challenge of a high level of drug resistance that has developed following earlier therapy with paclitaxel and other agents.
“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,” said Dr Thomas Rutherford, the study’s principal investigator. “The highly encouraging preclinical and clinical data that we have seen with phenoxodiol when it has been used as a chemo-sensitizer to date, gives us optimism that this strategy will provide the means to improve the survival of these late-stage cancer patients.”