Do You Qualify?
If you answered "yes" to all of these questions, you could be eligible for participation in the OVATURE (OVArian TUmor REsponse) trial. There is no limit on the number of previous cancer therapies you may have received, provided that you received at least two courses of platinum-based therapy. In addition, you cannot be pregnant. You will also have to meet other criteria to qualify to participate in this clinical research study. You may also want to consult with your doctor to know if this study is right for you. For other frequently asked questions, click here or e-mail us at info@OVATUREtrial.com. For a printable brochure highlighting study information, click here. About The Study The OVATURE trial will evaluate the safety and effectiveness of a new investigational drug called phenoxodiol in restoring sensitivity to the cancer cells of patients that have become resistant to standard chemotherapy drugs. Phenoxodiol has not yet been approved by the regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for commercial distribution. Phenoxodiol is a pill taken by mouth. Published research indicates that phenoxodiol has the ability to restore sensitivity to previously-treated ovarian cancer cells that have become resistant to standard chemotherapy drugs in laboratory studies. Previous Phase I/II clinical trials of phenoxodiol explored the optimal dose of phenoxodiol in cancer patients, and preliminary results show evidence of safety and effectiveness of phenoxodiol. This study is designed to evaluate the safety and effectiveness of daily phenoxodiol plus weekly carboplatin in women with either late-stage ovarian, fallopian or primary peritoneal cancer who have been previously treated with platinum-based drugs and whose tumor has become resistant to platinum-based drugs. In this study, ALL patients on the trial will receive an experimental treatment regimen of weekly carboplatin. Half of the patients in the trial will also receive the investigational drug phenoxodiol. The other half will receive a placebo (an inactive control pill), so that neither researchers nor patients can tell which arm the patient is on. Neither you nor the study doctor can choose which group you will be put in. You will have an equal chance of being placed in either of the two groups. Neither the patients nor the doctors will know to which treatment group you have been assigned. The information obtained from both arms of the study is expected by researchers to be beneficial to doctors and patients in the future. All patients will receive carboplatin on a weekly basis instead of receiving the customary carboplatin treatment of one intravenous infusion every two to three weeks. This is because pre-clinical data suggest that carboplatin should be given as frequently as possible when dosed in combination with phenoxodiol to achieve the best anti-tumor effect. Therefore, you will be required to visit the study site at least weekly for your intravenous infusion of carboplatin. In addition, you will have to take oral phenoxodiol or a control pill (placebo) by mouth on a daily basis. A change from every third week to weekly carboplatin may improve tumor response in patients whose tumors have become resistant to the standard once every third week regimen. Weekly carboplatin has been reported to improve tumor response in heavily pre-treated ovarian cancer patients.1 Therefore, all patients on the trial will be receiving therapy that researchers hope may be helpful. In previous studies, phenoxodiol did not increase the toxicity of other chemotherapy drugs. For example, a recent laboratory study demonstrated that phenoxodiol protects nerve cells from the toxic effects of cisplatin.2 Nonetheless, phenoxodiol use in combination with standard chemotherapy drugs may lead to the side effects known to be associated with these drugs. If you or your doctor are interested in obtaining more information on this research study or would like to participate, please click here to contact an OVATURE representative. You may also find out more about this trial by visiting http://clinicaltrials.gov (type OVATURE in the search box).
1 M. E. van der Burg, Gaast A. van der, I. Vergote, C. W. Burger, H. C. van Doorn, Wit R. de, G. Stoter, and J. Verweij. What is the role of dose-dense therapy? Int.J.Gynecol.Cancer 15 Suppl 3:233-240, 2005. |
