Analysis of Patients Treated With Bevacizumab Intraperitoneal for the Treatment of Refractory Malignant Ascites

NCT02891369 | Completed

• 1 other identifier: BEVASCITE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care. Conventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit. VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites. The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration. Studies in humans are few and the doses used are not consistent from one study to another.

Conditions

Refractory Malignant Ascites

Outcome Measures

Primary Outcomes (1)

• Assessment of the ascites volume

  Assessment of the ascites volume (mL) collected during paracentesis prior to the introduction of IP bevacizumab

  1 Hour before introduction of bevacizumab

Secondary Outcomes (2)

• Assessment of the TNM classification of the cancer

  Day1

• Assessment of the number of paracentis happened

  Month 12

Interventions

No intervention. Descriptive study OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with Refractory Malignant Ascites and wgho received bevacizumab intraperitoneal (IP) injection

You may qualify if:

• All assigns patients received at least one injection of bevacizumab intraperitoneal within GHPSJ between 01/01/2007 and 31/12/2014

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Meryam JARDIN, PharmD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 7, 2016
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 14, 2018

Record last verified: 2016-09

Locations

FR (1)