Clinical Trial: Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

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

Official Title: Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

Brief Summary: This study will evaluate the safety and efficacy of intraperitoneal administration of Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.

Detailed Summary: This protocol describes a pilot study to assess whether intraperitoneal Bevacizumab infusion is safe and improves the time to repeat paracentesis. In patients with non-draining malignant peritoneal effusion, published data suggests that the average time to repeat paracentesis in malignant ascites is 10-13 Days. The investigators' treatment will be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days.
Sponsor: Eastern Regional Medical Center

Current Primary Outcome:

  • Radiographic Improvement [ Time Frame: 14 days (+/-4 days) ]
    Radiographic improvement in area of intraperitoneal collection will be evaluated (between the area of the intraperitoneal collection on the ultrasound pre-procedure and ultrasound evaluation on day 14 (+/-4 days).
  • Volume Output [ Time Frame: 14 days (+/-4 days) ]
    Change in volume output from baseline to day 14 (+/-4 days)


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse Events [ Time Frame: 14 days (+/-4 days) ]

Adverse events will be judged possibly or probably related to intraperitoneal Bevacizumab infusion.


Original Secondary Outcome: Same as current

Information By: Eastern Regional Medical Center

Dates:
Date Received: July 1, 2015
Date Started: June 2015
Date Completion:
Last Updated: November 13, 2015
Last Verified: November 2015