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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00434109
Other study ID # MCC-14888
Secondary ID GA6181079
Status Completed
Phase Phase 2
First received February 9, 2007
Last updated September 7, 2012
Start date November 2006
Est. completion date February 2012

Study information

Verified date July 2012
Source H. Lee Moffitt Cancer Center and Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

This is a single-center, open-label, non-randomized, prospective phase II trial. Sutent treatment will be continued until disease progression, or excessive toxicity (as determined by treating physician or primary investigator), or until a maximum of eight cycles, whichever duration is shorter.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Progression Free Survival (PFS) at 12 Months Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started. 12 months No
Secondary Percentage of Participants With Overall Survival (OS) at One Year Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. 12 months No
Secondary Number of Participants With Partial Radiographic Response Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD. 12 months No
Secondary Number of Participants With Biochemical Response Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases. 12 months No
Secondary Number of Participants Requiring Dose Reduction Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects. 12 months Yes
Secondary Percentage of Participants With Overall Survival (OS) at 4 Years Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. 48 months No
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