Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

NCT02496286 | Terminated Phase 1

• 1 other identifier: EP2014013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Ascites

Keywords

Necessary paracentesis for symptom control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse Events

  14 days (+/-4 days)

Study Arms (1)

Eligible patients requiring paracentesis for symptom control

EXPERIMENTAL

Drug: Intraperitoneal Bevacizumab

Interventions

Intraperitoneal Bevacizumab DRUG

Bevacizumab 200mg diluted in 250 ml of normal saline

Eligible patients requiring paracentesis for symptom control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Regional Medical Center: lead

Study Sites (1)

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 14, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

US (1)