P.D. : Arizona es una de las 104 Localizaciones en donde Janssen lleva a cabo la Fase III con Yondelis Ovario combinado con Doxil ... ensayo de Fase III que no solo incluye a EEUU , tambien se lleva a cabo en China , Rusia , Uk , SudAfrica , Switzerland , Nueva Zelanda , Australia e Israel .
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PHOENIX ( March 5, 2014) .
Arizona Oncology, a practice affiliated with The US Oncology Network and US Oncology Research, is enrolling patients in clinical trials at a faster rate than ever before, giving patients new, timely options when they need them most.
In Phoenix, Gynecological Oncologists Snehal Bhoola, M.D., and Michael Janicek, M.D., enrolled the first two patients into a Phase III, international ovarian cancer clinical trial in October. Both are Arizona Oncology patients and Phoenix area residents who may benefit from the study.
The trial will examine whether two drugs—pegylated liposomal doxorubicin and trabectedin—are more effective in treating advanced-relapsed epithelial ovarian, primary peritoneal or fallopian tube cancer when prescribed together. Pegylated liposomal doxorubicin is already a commonly used therapy for ovarian cancer.
“Arizona Oncology has access to some of the best trials in the world,” said Lisa Holland, vice president, US Oncology Research. “We work at great speed to open trials quickly so that patients with immediate needs have options. Many can’t wait six months or a year for a trial. We take pride in getting patients access faster.”
With recurring cases of ovarian cancer, both Arizona Oncology patients needed access to the trial quickly. Both began treatment in late October.
Currently, trabectedin is approved for use in Europe, Russia, and other regions, however, it is still investigational in the United States and not approved by the U.S. Food and Drug Administration (FDA). Both the FDA and the European Commission have granted orphan drug status to trabectedin for soft tissue sarcomas and ovarian cancer.
Arizona Oncology enrolls patients in trials throughout the state, including in Tucson, where Gynecological Oncologist Joseph Buscema, M.D., practices.
“US Oncology Research gives Arizona Oncology the ability to enroll patients quickly in a huge array of trials that are patient-specific. Patients get access to investigational, targeted therapies that are capable of addressing the specific features of their specific cancer. What we can do now is look for cancer mutations that exist in each cancer’s DNA and provide a drug that targets that mutation,” said Dr. Buscema.
The ovarian trial examining the pegylated liposomal doxorubicin-trabectedin combination will continue to enroll patients for at least a year. It is sponsored by Janssen Research & Development. The compound is being co-developed with PharmaMar.
Arizona Oncology has seven gynecologic oncologists practicing statewide. They specialize in the treatment of ovarian, uterine, vaginal, cervical, fallopian tube and vulvar cancers. Doctors test patients for the genes that may lead to cancer, operate using the most cutting-edge robotic surgical equipment, and are always on the forefront of new treatments and trials.
Ovarian cancer will kill an estimated 14,000 women in the U.S. this year, according to the American Cancer Society. Cervical cancer will kill an estimated 4,000.
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