Clinical Trial: Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites

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.


Detailed Summary:

Main objective / secondary:

The objective of this study is to describe the population, adverse effects, the volume of ascites product and time between paracentesis in patients receiving bevacizumab in intraperitoneal through a refractory malignant ascites.

Methodology :

This is a retrospective study mono centric and non-interventional. data collected

  • Name,
  • date of birth,
  • dates and numbers injection of bevacizumab doses
  • side effects,
  • type of cancer, TNM classification,
  • ascites volume collected during paracentesis prior to the introduction of IP bevacizumab,
  • frequency of paracentesis before the introduction of IP bevacizumab,
  • ascites volume collected during paracentesis after the introduction of IP bevacizumab,
  • frequency after paracentesis after the introduction of IP bevacizumab,
  • albumin
  • Number of lines of chemotherapy received
  • Treatment monotherapy or in combination with other chemotherapies
  • WHO Stadium in each course
  • Date of death

supports

  • Data collection from CHIMIO® software DxCare® and non-computerized patient records.
  • Series anonymized patient data on Excel®
    Sponsor: Groupe Hospitalier Paris Saint Joseph

    Current Primary Outcome: Assessment of the ascites volume [ Time Frame: H-0 ]

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


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Assessment of the TNM classification of the cancer [ Time Frame: Day1 ]
      type of cancer, TNM
    • Assessment of ascites volume collected during paracentesis [ Time Frame: H-0 ]
      Assessment of ascites volume collected during paracentesis prior to the introduction of IP bevacizumab
    • Assessment of the number of paracentis happened [ Time Frame: Month 12 ]
      frequency after paracentesis after the introduction of IP bevacizumab


    Original Secondary Outcome: Same as current

    Information By: Groupe Hospitalier Paris Saint Joseph

    Dates:
    Date Received: September 1, 2016
    Date Started: February 2015
    Date Completion:
    Last Updated: September 1, 2016
    Last Verified: September 2016