Irinotecan and Bevacizumab for Recurrent Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Irinotecan in Combination With Bevacizumab for the Treatment of Recurrent Ovarian Cancer.|
- Progression Free Survival (PFS) Rate at 6 Months [ Time Frame: 6 months from the start of treatment ] [ Designated as safety issue: No ]The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.
- Overall Response Rate (ORR) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]ORR is defined as the percentage of all patients with confirmed partial response (PR) or complete response (CR). PR and CR are evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range).
- Median Progression Free Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]Defined as the length of time from the start of treatment that half of the patients are still alive and without disease progression. Progression is evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range; progression is defined on the basis of a confirmed doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level)
- Median Overall Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]Defined as the length of time from the start of treatment that half of the patients are still alive.
- Number of Patients Who Experienced Grade 3 and Higher Toxicities [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Irinotecan with Bevacizumab
Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
Other Names:Drug: Bevacizumab
Other Name: Avastin
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 vascular endothelial growth factor (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091259
|United States, New York|
|Bellevue Hospital Center (NYU Langone Medical Center affiliate)|
|New York, New York, United States, 10016|
|New York University Clinical Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Franco Muggia, MD||New York Unviersity Cancer Institute|