Clinical Trial: Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Percentage of Participants With Progression Free Survival (PFS) at 12 Months [ Time Frame: 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.


Original Primary Outcome: Progression-free survival rate at 12 months after first embolization

Current Secondary Outcome:

  • Percentage of Participants With Overall Survival (OS) at One Year [ Time Frame: 12 months ]
    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.
  • Number of Participants With Partial Radiographic Response [ Time Frame: 12 months ]
    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.
  • Number of Participants With Biochemical Response [ Time Frame: 12 months ]
    Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.
  • Number of Participants Requiring Dose Reduction [ Time Frame: 12 months ]
    Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.
  • Percentage of Participants With Overall Survival (OS) at 4 Years [ Time Frame: 48 months ]
    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.


Original Secondary Outcome:

  • Overall survival
  • Duration of Response
  • Objective radiographic response rate
  • Biochemical response rate (>50% reduction in tumor marker)
  • Treatment toxicity


Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: February 9, 2007
Date Started: November 2006
Date Completion:
Last Updated: September 7, 2012
Last Verified: July 2012