Fallopian Tube Cancer Clinical Trial
Official title:
A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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