Clinical trial NCT02891369: Analysis of Patients Treated With Bevacizumab Intraperitoneal for the Treatment of Refractory Malignant Ascites
Official title: Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Malignant Ascites
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with Refractory Malignant Ascites and wgho received bevacizumab intraperitoneal (IP) injection

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 description: 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®

Circulation mode and data processing and not opposition patient The anonymous data are entered on a computer file and centralized within the pharmacy department by the investigator of the Groupe Hospitalier Saint Joseph Paris, Carole METZ, to be processed locally.

For the statistical analysis, quantitative variables are expressed by their mean, standard deviations, their minimum and maximum values as appropriate. The variables will be expressed in numbers and percentages. Descriptive data analyzes, correlations between the study variables and more specific tests to determine the prognostic value of variable can be used.

This is a single-center retrospective cohort within the GHPSJ. Patients are aware of the potential use of their data in their files for medical research by information contained in the handbook of the institution for patients.

Development of the study:

* The list of patients who received bevacizumab injection is obtained from the CHIMIO® software.
* The data collected is validated by a multidisciplinary way oncologists and pharmacists.
* Collection and analysis of data by the internal pharmacy from computerized patient records (DxCare®) or not computerized.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Assessment of the ascites volume
timeFrame: 1 Hour before introduction of bevacizumab
Secondary outcomes:
measure: Assessment of the TNM classification of the cancer
timeFrame: Day1
measure: Assessment of the number of paracentis happened
timeFrame: Month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Meryam JARDIN, PharmD
role: PRINCIPAL_INVESTIGATOR
References: