Multiple Endocrine Neoplasia Type 1 Clinical Trial
Official title:
Perfusion CT as Predictive Biomarker in a Phase II Study of Ziv-Aflibercept in Patients With Advanced Pancreatic Neuroendocrine Tumors
This phase II trial studies ziv-aflibercept in treating and perfusion computed tomography perfusion imaging in predicting response in patients with pancreatic neuroendocrine tumors that have spread to other parts of the body or cannot be removed by surgery. Ziv-aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor. Diagnostic procedures, such as computed tomography perfusion, imaging may help measure a patient's response to ziv-aflibercept treatment.
PRIMARY OBJECTIVES:
I. Estimate the objective response rate (RR) of ziv-aflibercept among patients with advanced
pancreatic neuroendocrine tumors (NET)s according to Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1.
II. Test the following hypotheses: that baseline perfusion computed tomography (CT)
parameters can predict which patients with advanced pancreatic neuroendocrine tumors (pNETs)
will respond to treatment with ziv-aflibercept.
SECONDARY OBJECTIVES:
I. Estimate progression free survival (PFS) duration among patients treated with
ziv-aflibercept.
II. Evaluate the relationship between response rate and baseline blood volume (BV) and
between response rate and baseline permeability surface (PS).
TERTIARY OBJECTIVES:
I. Determine whether post-treatment changes in BV expressed as relative change from baseline
correlate with response to ziv-aflibercept.
II. Determine whether post-treatment tumor blood flow (BF) (absolute measurement) correlates
with response to ziv-aflibercept.
III. Determine whether post-treatment changes in BF and, BV, expressed as relative change
from baseline, correlate with relative change in sum of tumor diameters (RECIST 1.1
measurements).
IV. Determine the effect of ziv-aflibercept therapy on post-treatment blood flow (BF), BV,
mean transit time (MTT), and PS at 4 weeks after treatment.
V. Evaluate the changes in tumor perfusion parameters at time of progression.
OUTLINE:
Patients receive ziv-aflibercept intravenously (IV) over 60-120 minutes on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients
undergo computed tomography perfusion imaging at baseline, day 21 of course 1, and at time of
progression.
After completion of study treatment, patients are followed up periodically.
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