Clinical Trial: A Study of Bevacizumab to Prevent Malignant Ascites
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Prospective, Phase II Trial of Intravenous Bevacizumab (Avastin) for the Prevention of Recurrent Malignant Ascites
Brief Summary:
The purpose of this study is to determine the effectiveness of using Bevacizumab in the prevention of recurrent malignant ascites.
Ascites is a debilitating and unpleasant complication of several types of cancer. Animal and laboratory studies have shown that tumor cell production and/or increases in the amount of Vascular Endothelial Growth Factor (VEGF) is a major cause of the formation of malignant ascites. Therefore, giving patients with malignant ascites a drug that targets and neutralizes VEGF should prevent the recurrence of malignant ascites following paracentesis (a procedure to remove fluid from the abdominal cavity).
Detailed Summary: All subjects will be treated with an intravenous infusion of the experimental drug (Bevacizumab 15 mg/kg) every 3 weeks for a total of twelve (12) weeks on study. The primary endpoint will be time to the need for repeat abdominal paracentesis after the start of therapy. Secondary endpoints will include an analysis of the mean number of paracenteses required in each subject over the course of 3 months, determination of the repeat paracentesis response rate (proportion of subjects who have a doubling in baseline time to repeat paracentesis) and an assessment of the effect of treatment on quality of life using a subject questionnaire.
Sponsor: Baylor College of Medicine
Current Primary Outcome: To determine the repeat paracentesis response rate defined as a doubling of the patient's baseline time to repeat paracentesis. [ Time Frame: 12 weeks after initiation of study treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess the time to the need for the first repeat abdominal paracentesis after the start of Bevacizumab therapy as compared with historical control data. [ Time Frame: Unspecified - depends upon when subject will need repeat paracentesis ]
- To analyze the mean number of paracentesis procedures required in each patient over the course of three months. [ Time Frame: 12 weeks after the initiation of study treatment ]
- To assess the effect of anti-VEGF therapy on quality of life in patients with malignant ascites. [ Time Frame: Every three weeks while on-study ]
Original Secondary Outcome: Same as current
Information By: Baylor College of Medicine
Dates:
Date Received: May 21, 2009
Date Started: July 2009
Date Completion:
Last Updated: June 2, 2015
Last Verified: February 2012
