Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Ascites
• Intervention / Treatment: Drug: Intraperitoneal Bevacizumab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19124
      • Eastern Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eligible patients requiring paracentesis for symptom control	Drug: Intraperitoneal Bevacizumab; Bevacizumab 200mg diluted in 250 ml of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Volume Output	Change in volume output from baseline to day 14 (+/-4 days)	14 days (+/-4 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events will be judged possibly or probably related to intraperitoneal Bevacizumab infusion.	14 days (+/-4 days)

Collaborators and Investigators

• Sponsor: Eastern Regional Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Necessary paracentesis for symptom control
• Additional Relevant MeSH Terms: Pathologic Processes; Ascites; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: EP2014013