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Hospitals and treatment centers throughout the United States, Europe andAustralia are serving as trial sites, and www.OVATUREtrial.com will guidepatients to site locations as they begin recruiting. Ovarian cancer patientswhose cancer initially responded to chemotherapy, but has since becomeresistant or refractory to traditional platinum treatments are eligible toparticipate.
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In the U.S. 30 sites are planned and the current trial locations includeYale University School of Medicine in New Haven, Connecticut; the Women'sCancer Center of Nevada in Las Vegas, Nevada; the University of TexasSouthwestern Medical Center at Dallas in Dallas, Texas; Providence Hospitaland Medical Centers in Southfield, Michigan; Hematology Oncology in Stamford,Connecticut; Gabrail Cancer Center in Canton, Ohio; Northern Virginia PelvicSurgery Associates in Annandale, Virginia; and Chattanooga GYN Oncology inChattanooga, Tennessee.
In Australia, the current trial locations include Prince of Wales Hospitaland Westmead Hospital in Sydney; Royal Adelaide Hospital, in Adelaide; andMater Adult Hospital in Brisbane. In Europe, 26 sites are planned andrecruitment has commenced at UZ Leuven Gynaecological Oncology in Leuven,Belgium.
The trial is studying the safety and effectiveness of the drugphenoxodiol, which has not yet been approved for marketing by the FDA, whenused in combination with weekly doses of the chemotherapy drug, carboplatin.The trial will consist of two double blind treatment arms. Patients in onetrial arm will receive weekly carboplatin and phenoxodiol. Patients in theother trial arm will also receive weekly carboplatin, but a placebo will besubstituted for phenoxodiol. Neither patients, nor their doctors will know towhich trial arm the patients are randomized.
A change from receiving carboplatin (or cisplatin) every two to threeweeks to a weekly carboplatin regimen has been reported to provide a tumorresponse in some patients with recurrent ovarian cancer.(1) In addition tolearning more about the safety and efficacy of phenoxodiol, researchers willlearn 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 bedue to its disruption of several key targets specific to tumor cellbiochemistry.
In a prior Phase II clinical trial, phenoxodiol was tested in combinationwith either cisplatin or paclitaxel. Twenty one patients with late stageovarian cancer that had become refractory to platinum (cisplatin orcarboplatin) and 19 patients that had become resistant to paclitaxel therapy,following multiple courses of chemotherapy, were treated with phenoxodiol andcisplatin or phenoxodiol and paclitaxel, respectively. The cisplatin (40mg/m2) or paclitaxel (80 mg/m2) was administered weekly, and phenoxodiol wasadministered by intravenous infusion at 3 mg/kg on two consecutive daysimmediately prior to the cisplatin administration. Treatment was for sixweeks and was continued until dose limiting toxicity or disease progression.
In this trial, as measured using the RECIST criteria, in the cispla
