A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug P...(urope 26 sites areplanned and recruitmen...),Health

The trial is studying the safety and effectiveness of the drug phenoxodiol, which has not yet been approved for marketing by the FDA, when used in combination with weekly doses of the chemotherapy drug, carboplatin. The trial will consist of two double blind treatment arms. Patients in one trial arm will receive weekly carboplatin and phenoxodiol. Patients in the other trial arm will also receive weekly carboplatin, but a placebo will be substituted for phenoxodiol. Neither patients, nor their doctors will know to which trial arm the patients are randomized.

A change from receiving carboplatin (or cisplatin) every two to three weeks to a weekly carboplatin regimen has been reported to provide a tumor response in some patients with recurrent ovarian cancer.(1) In addition to learning more about the safety and efficacy of phenoxodiol, researchers will learn more about the efficacy of weekly carboplatin.

In laboratory studies using animal models of cancer and human cell lines, phenoxodiol was shown to reverse chemoresistance to standard chemotherapies, including platinum drugs, taxanes, gemcitabine, topotecan and doxorubicin. The ability of phenoxodiol to reverse multi-drug resistance is thought to be due to its disruption of several key targets specific to tumor cell biochemistry.

In a prior Phase II clinical trial, phenoxodiol was tested in combination with either cisplatin or paclitaxel. Twenty one patients with late stage ovarian cancer that had become refractory to platinum (cisplatin or carboplatin) and 19 patients that had become resistant to paclitaxel therapy, following multiple courses of chemotherapy, were treated with phenoxodiol and cisplatin or phenoxodiol and paclitaxel, respectively. The cisplatin (40 mg/m2) or paclitaxel (80 mg/m2) was administered weekly, and phenoxodiol was administered by intravenous infusion at
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