A Study of Bevacizumab to Prevent Malignant Ascites

Malignant Ascites Clinical Trial

Official title: A Prospective, Phase II Trial of Intravenous Bevacizumab (Avastin) for the Prevention of Recurrent Malignant Ascites

Status Withdrawn

Clinical Trial 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).

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites

• NCT number: NCT00908219
• Study type: Interventional
• Source: Baylor College of Medicine
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2009
• Completion date: February 2011