Clinical Trial: Trial of Sunitinib for Refractory Malignant Ascites

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites

Brief Summary: The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.

Detailed Summary: This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.
Sponsor: Milton S. Hershey Medical Center

Current Primary Outcome: Overall response rate where a response is considered to be 3 cm or more decrease in abdominal girth. [ Time Frame: An average of every 6 weeks ]

A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.


Original Primary Outcome: Overall response rate where a response is considered to be 3 cm or more decrease in abdominal girth. [ Time Frame: Every 6 weeks ]

Current Secondary Outcome: Understand the mechanism of VEGF inhibition in ascites, using paracentesis samples. [ Time Frame: 3 months ]

Understand the mechanism of VEGF inhibition in ascites, using paracentesis samples.


Original Secondary Outcome: Understand the mechanism of VEGF inhibition in ascites, using paracentesis samples. [ Time Frame: 3 months ]

Information By: Milton S. Hershey Medical Center

Dates:
Date Received: November 21, 2008
Date Started: May 2007
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017