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

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02101918
Phase
PHASE2
Status
Completed

Conditions

  • Multiple Endocrine Neoplasia Type 1
  • Pancreatic Neuroendocrine Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography Perfusion Imaging — RADIATION
    Undergo computed tomography perfusion imaging
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Ziv-Aflibercept — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jun 18, 2014
Status verified
Mar 2020
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ziv-aflibercept, perfusion CT)
    Patients receive ziv-aflibercept 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.

Primary Outcome Measure

Objective Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Through study completion an average of 19 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center-International PlazaTampaFlorida33607-
M D Anderson Cancer CenterHoustonTexas77030-

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