Phase II Study of Irinotecan in Combination With Bevacizumab for the Treatment of Recurrent Ovarian Cancer.
Accumulating data suggests that angiogenesis plays a critical role in the formation and
development of a number of solid tumors including ovarian cancer. For women with ovarian
cancer, a direct relationship between VEGF expression and tumor vascularity has been
documented. In vivo and in vitro data has demonstrated that increased angiogenesis and
microvessel density are negative prognostic factors for women with ovarian cancer. These
observations have fueled interest in incorporating anti-angiogenic agents into ovarian
cancer treatment regimens.
Several phase II trials of irinotecan in patients with epithelial ovarian cancer showed that
the drug had efficacy in both chemotherapy-naïve patients and in those who had been
previously treated with standard therapies, including platinum-based compounds, radiation,
or both. Combination of bevacizumab, an antibody against VEGF, and irinotecan was studied in
colorectal cancer and malignant brain neoplasms. In these trials, the combination was shown
to be safe and effective.
The purpose of this study is to evaluate the efficacy and toxicity of irinotecan in the
treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer
when combined with bevacizumab. In this phase II open-label study patients will be treated
with bevacizumab 15 mg/kg and irinotecan 175mg/m^2 every 3 weeks. Patients will undergo
pre-treatment evaluation within 4 weeks of enrolling into the study. Clinical and laboratory
evaluation will be performed every 3 weeks. Imaging studies and CA-125 measurements will be
used to assess response to treatment.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6-month progression free survival
This is the total time needed to satisfy the endpoint.
Franco Muggia, MD
New York Unviersity Cancer Institute
United States: Institutional Review Board
|New York University Clinical Cancer Center||New York, New York 10016|
|Bellevue Hospital Center (NYU Langone Medical Center affiliate)||New York, New York 10016|