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Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

Primary Purpose

Malignant Ascites

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intraperitoneal Bevacizumab
Sponsored by
Eastern Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Ascites focused on measuring Necessary paracentesis for symptom control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eligible patients requiring paracentesis for symptom control

Arm Description

Outcomes

Primary Outcome Measures

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).
Volume Output
Change in volume output from baseline to day 14 (+/-4 days)

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2015
Last Updated
July 10, 2017
Sponsor
Eastern Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02496286
Brief Title
Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
Official Title
Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of Enrollment
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Regional Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Ascites
Keywords
Necessary paracentesis for symptom control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eligible patients requiring paracentesis for symptom control
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intraperitoneal Bevacizumab
Intervention Description
Bevacizumab 200mg diluted in 250 ml of normal saline
Primary Outcome Measure Information:
Title
Radiographic Improvement
Description
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).
Time Frame
14 days (+/-4 days)
Title
Volume Output
Description
Change in volume output from baseline to day 14 (+/-4 days)
Time Frame
14 days (+/-4 days)
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events will be judged possibly or probably related to intraperitoneal Bevacizumab infusion.
Time Frame
14 days (+/-4 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States

12. IPD Sharing Statement

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Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

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