About the Phase 2 Trial
The Phase 2 trial was initiated in March 2011, and is titled, "A Randomized Phase II Evaluation of Single-Agent Bevacizumab (IND #7921) (NSC #704865) and Combination Bevacizumab with Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma." The Study chair and co-chairs are Bradley Monk, MD, Creighton University School of Medicine, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, Robert L.Coleman, MD, University of Texas MD Anderson Cancer Center, Houston, Texas and Carol Aghajanian, MD, Memorial Sloan-Kettering Cancer Center, respectively. The study is being conducted at more than 80 sites in the U.S.
To be eligible for the study, patients must have measurable or detectable recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, and must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound. Patients can be either platinum-sensitive or platinum-resistant but cannot have received more than two prior chemotherapy regimens.
Patients are randomized into two arms: one arm receives bevacizumab 15 mg/kg IV on day 1 and then every three weeks; the second arm receives bevacizumab plus fosbretabulin tromethamine 60 mg/m 2 IV on day 1 and then every three weeks. Patients are treated until disease progression or until adverse effects prohibit further therapy. The primary endpoint of the Phase 2 trial is progression-free survival. Secondary endpoints include safety, overall survival and objective responses by treatment arm.About the Gynecologic Oncology Group The Gynecologic Oncology Group (GOG) is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. The GOG is one of the National Cancer Institute's funded cooperative groups. The GOG is the only group that focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus, and cervix. The GOG is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, basic scientists, quality of life experts, data managers, and administrative personnel.
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