OXiGENE, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, has achieved an important safety objective in a scheduled interim toxicity analysis, and is expected to continue to full enrollment in the randomized phase II study evaluating the combination of Zybrestat (fosbretabulin tromethamine or CA4P) and bevacizumab to treat patients with advanced platinum-sensitive ovarian cancer.
The phase II study (GOG 186I) is being conducted by the Gynaecologic Oncology Group (GOG) under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). The fosbretabulin tromethamine is being provided to CTEP under a Cooperative Research and Development Agreement (CRADA) with OXiGENE and the bevacizumab is being provided under a CRADA with Genentech, Inc.
“This phase II study is a major initiative for OXiGENE, potentially pointing the way to a promising new treatment option for patients with advanced ovarian cancer who have few if any therapeutic options," said Jai Balkissoon, MD, FACS, vice president Clinical Development, OXiGENE. “Having shown that the combination of Zybrestat and bevacizumab has passed a critical safety hurdle, we look forward to continuing to collaborate with the GOG and CTEP to complete the trial, and are optimistic that the final efficacy and safety outcomes could inform the decision to move forward to a pivotal registration programme.”
The interim toxicity analysis was based on 25 evaluable patients who received therapy. As only one patient had a protocol specified serious adverse event, the study met the safety criteria and is proceeding as planned.
The phase II 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 Centre, Phoenix, Arizona, Robert L Coleman, MD, University of Texas MD Anderson Cancer Centre, Houston, Texas and Carol Aghajanian, MD, Memorial Sloan-Kettering Cancer Centre, respectively. The study is being conducted at more than 60 sites in the US.
To be eligible for the study, patients must have measurable or detectable platinum-sensitive 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 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/m2 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 II trial is progression-free survival. Secondary endpoints include safety, overall survival and objective responses by treatment arm. OXiGENE anticipates final data analysis of the trial in 2013.