Ziv-Aflibercept in Treating and Computed Tomography Perfusion Imaging in Predicting Response in Patients With Pancreatic Neuroendocrine Tumors That Are Metastatic or Cannot Be Removed By Surgery
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.
Pancreatic Polypeptide Tumor
Recurrent Islet Cell Carcinoma
Radiation: computed tomography perfusion imaging
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Perfusion CT as Predictive Biomarker in a Phase II Study of Ziv-Aflibercept in Patients With Advanced Pancreatic Neuroendocrine Tumors|
- Objective response rate according to RECIST 1.1 [ Time Frame: Up to1 year ] [ Designated as safety issue: No ]90% exact confidence interval will be constructed for the overall group and for all the marker subgroups respectively. Fisher's exact test will be applied to test the equal response rates between the two groups with a one-sided 5% type I error rate.
|Study Start Date:||June 2014|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ziv-aflibercept, perfusion CT)
Patients receive ziv-aflibercept IV over 60 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.
Other Names:Radiation: computed tomography perfusion imaging
Undergo computed tomography perfusion imaging
Other Names:Other: laboratory biomarker analysis
I. Estimate the objective response rate (RR) of aflibercept (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 aflibercept.
I. Estimate progression free survival (PFS) duration among patients treated with aflibercept.
II. Evaluate the relationship between response rate and baseline blood volume (BV) and between response rate and baseline permeability surface (PS).
I. Determine whether post-treatment changes in BV expressed as relative change from baseline correlate with response to aflibercept.
II. Determine whether post-treatment tumor blood flow (BF) (absolute measurement) correlates with response to 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 aflibercept therapy on post-treatment 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.
Patients receive ziv-aflibercept intravenously (IV) over 60 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02101918
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Jonathan R. Strosberg 813-745-3636 Jonathan.email@example.com|
|Principal Investigator: Jonathan R. Strosberg|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: James C. Yao 713-792-2828 firstname.lastname@example.org|
|Principal Investigator: James C. Yao|
|Principal Investigator:||James Yao||M.D. Anderson Cancer Center|