MedTrace Logo

Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization

NCT00434109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-09-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Neuroendocrine Tumor
  • Islet Cell Tumor

Interventions

DRUG

Sunitinib malate

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.

PROCEDURE

Hepatic Artery Embolizations

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jonathan Strosberg, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00434109 on ClinicalTrials.gov