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Gynecologic Oncology Group Initiates Study To Examine Progression-Free Time, Overall Survival for Xyotax
"In a clinical trial by the Southwest Oncology Group (SWOG) and the GOG, the administration of monthly paclitaxel therapy for a year given as maintenance chemotherapy was reported to prolong the time to progression, however, according to the protocol the study was closed before determining overall survival and therefore maintenance therapy is not considered a standard of care," stated Maurie Markman, MD, Vice President for Clinical Research at The University of Texas M. D. Anderson Cancer Center and a principal investigator on the trial. "In the XYOTAX trial, we hope to demonstrate that monthly maintenance of XYOTAX therapy improves both overall and progression-free survival of patients with advanced ovarian cancer, without significant side effects that diminish patient quality of life. We're pleased to collaborate with CTI on this study, which has very important implications for ovarian cancer patients."
The trial, submitted under the FDA's special protocol assessment (SPA) guidance, will investigate the safety and efficacy of XYOTAX administered over a 10-minute infusion once monthly for 12 months compared to no maintenance in ovarian cancer patients who have achieved a complete remission following standard first-line chemotherapy. The principal endpoints of the study include progression-free and overall survival. A third treatment arm administering monthly paclitaxel will be used to assess the potential quality of life advantages of XYOTAX by measuring differences in toxicity and tolerability between treatment groups.
An interim analysis using progression-free survival is planned, which provides for a potential accelerated NDA filing.
According to a cancer audit, approximately 27,000 patients in 2004 in the United States received first-line chemotherapy for advanced ovarian cancer. The standard first-line regimen consists of paclitaxel (175mg/m2) and carboplatin (AUC 6) for up to six cycles. Approximately 70 percent of patients will achieve a complete response with first-line therapy and would be eligible for treatment on the XYOTAX pivotal trial.
About The Gynecologic Oncology Group
The GOG is a national non-profit organization dedicated to clinical research in the field of gynecologic cancer. The purpose of the GOG is to improve the treatment of gynecologic cancer. These goals are addressed through research encompassing surgery, radiation therapy, chemotherapy, pathology, immunology and/or gynecologic nursing. To promote this mission, the GOG receives support from the National Cancer Institute (NCI) of the National Institutes for Health. The GOG has a history of establishing treatment standards for ovarian cancer, demonstrating improved survival with platinum therapy in the early 1980s and again with the combination of paclitaxel and platinum in the mid-1990s.
XYOTAX(TM) (paclitaxel poliglumex) is a pharmaceutical that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer. This polymer technology results in a new chemical entity, designed to selectively deliver higher and potentially more effective levels of active chemotherapeutics to tumors. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. Because more of the chemotherapy is targeted to the tumor and the levels of chemotherapy delivered to normal tissue are reduced, XYOTAX may be more effective and have less severe side effects than currently available chemotherapeutics.
Source: Cell Therapeutics, Inc.