Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

NCT ID: NCT02496286

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-08-31

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.

Conditions

Malignant Ascites

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Study Groups

Eligible patients requiring paracentesis for symptom control

Group Type: EXPERIMENTAL

Intraperitoneal Bevacizumab

Intervention Type: DRUG

Bevacizumab 200mg diluted in 250 ml of normal saline

Interventions

Intraperitoneal Bevacizumab

Bevacizumab 200mg diluted in 250 ml of normal saline

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

EP2014013

Identifier Type: -

Identifier Source: org_study_id