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 — RADIATIONUndergo computed tomography perfusion imaging
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Ziv-Aflibercept — BIOLOGICALGiven 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | - |
| Moffitt Cancer Center-International Plaza | Tampa | Florida | 33607 | - |
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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