A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas
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.
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
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate, evaluated according to the RECIST criteria
Up to 3 years
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|City of Hope||Duarte, California 91010|
|UC Davis Comprehensive Cancer Center||Sacramento, California 95817|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|University of Southern California||Los Angeles, California 90033|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|
|Peoria Gynecologic Oncology||Peoria, Illinois 61603|