CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Sunitinib malate +1 moredrug
Likely dose
Sunitinib malate 37.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00434109
NCT00434109Phase 2Completed
CompareCT.gov

Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization for Metastatic Gastrointestinal Neuroendocrine Tumors

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Feb 12, 2007·Updated Sep 14, 2012

In Brief

A Phase 2 clinical trial evaluating Sunitinib malate and Hepatic Artery Embolizations for Neuroendocrine Tumor and Islet Cell Tumor. Completed, enrolled 39 participants across 1 site.

Detailed Summary

The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Tumor, Islet Cell Tumor
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2007
Enrollment StartNov 1, 2006
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 19.4 years ago

Interventions

Sunitinib malatedrug

Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks. No fewer than seven days shall separate treatment with Sutent and scheduling of hepatic artery embolizations.

Hepatic Artery Embolizationsprocedure

1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor.