Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

Malignant Ascites Clinical Trial

Official title:

Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02496286
• Other study ID #: EP2014013
• Status: Terminated
• Phase: Phase 1
• First received: July 1, 2015
• Last updated: July 10, 2017
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: July 2017
• Source: Eastern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will be included in the case of:

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 2

• Participants must be 18 years of age or older

• Have ascites of malignant disease

• Have symptoms related to ascites

• Ascites Index above 0.05 (AI ? 0.05)

• Be an English speaking patient or have an interpreter available

• Be able to understand and comply with all study requirements and the implications of off-label use of intraperitoneal Bevacizumab

• Have had at least two paracentesis within the last 4 weeks

Exclusion Criteria:

• Patients will be excluded in the case of:

• Ascites due to non-malignant cause

• Concurrent treatment with systemic chemotherapy that has a realistic chance of controlling the ascites

• Concurrent treatment with intraperitoneal Bevacizumab

• life expectancy of less than 2 weeks

• A history of bowel perforation or fistula

• Symptoms or signs suggestive of bacterial peritonitis

• Child's C cirrhosis

• Uncontrolled hypertension

• Surgery within 28 days of catheter treatment

• Evidence of coagulopathy

• Symptoms suggestive of bowel obstruction

• Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.

• Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.

• Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

• Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation)

• Patients with pre-existing 3 + or greater urine dipstick reading proteinuria

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites

Intervention

Drug:
• Intraperitoneal Bevacizumab
Bevacizumab 200mg diluted in 250 ml of normal saline

Locations

Country	Name	City	State
United States	Eastern Regional Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Improvement	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).	14 days (+/-4 days)
Primary	Volume Output	Change in volume output from baseline to day 14 (+/-4 days)	14 days (+/-4 days)
Secondary	Adverse Events	Adverse events will be judged possibly or probably related to intraperitoneal Bevacizumab infusion.	14 days (+/-4 days)