NCT02496286

Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Eastern Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Malignant Ascites

Interventions

Type	Name	Description
DRUG	Intraperitoneal Bevacizumab	Bevacizumab 200mg diluted in 250 ml of normal saline

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-07-14
• Last updated: 2017-07-12

Locations

1 site across 1 country: United States