This phase II trial is studying how well ziv-aflibercept works in treating patients with locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap (ziv-aflibercept). II. To assess the incidence of disease stabilization, as measured by 6-month progression-free survival, in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap. SECONDARY OBJECTIVES: I. To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap. \* As of 24 October 2012, overall survival follow-up is to be discontinued for the one remaining patient on long term follow-up, who has been off protocol therapy for at least 3 years. Time to progression and median survival times have been based on the currently available data. II. To assess the toxicity associated with VEGF-Trap in patients with recurrent or metastatic gynecologic soft-tissue sarcoma. III. To characterize the population pharmacokinetics of VEGF-Trap and to explore for demographic and clinical covariates OUTLINE: This is an open-label, multicenter study. Patients are stratified according to histology (uterine leiomyosarcoma vs malignant mixed mullerian tumor/carcinosarcoma). Patients receive ziv-aflibercept over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline, every 8 weeks during treatment, and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay (ELISA). After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Given IV
City of Hope
Duarte, California, United States
University of Southern California
Los Angeles, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, United States
Peoria Gynecologic Oncology
Peoria, Illinois, United States
University of Michigan University Hospital
Ann Arbor, Michigan, United States
Fox Chase Cancer Center
Rockledge, Pennsylvania, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
...and 6 more locations
Objective Response Rate, Evaluated According to the RECIST Criteria
Time frame: Up to 3 years
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)
Time frame: 6 months
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)
Time frame: 6 months
Survival (Leiomyosarcoma Group)
Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
Time frame: Up to 3 years
Survival (Carcinosarcoma Group)
Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
Time frame: Up to 3 years
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