Clinical trial NCT00216372: Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
Official title: Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intestinal Obstruction
Carcinoma
Peritoneal Neoplasms
Keywords: carcinomatosis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.


Eligibility criteria: Inclusion Criteria:

* digestive obstruction located in the upper part of the gastro-intestinal tract
* digestive obstruction of malignant origin
* peritoneal carcinomatosis confirmed by a CT Scan
* at least two vomiting episodes per day or a presence of a nasogastric suction tube
* inoperable patients

Exclusion Criteria:

* specific anticancer therapy within the previous 15 days
* signs of bowel perforation
* somatostatin or any analogue as treatment of the bowel obstruction

Primary outcomes:
measure: Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence)
timeFrame: On day 7 (plus 1 day at the latest) after the first injection
Secondary outcomes:
measure: Number of daily vomiting episodes or measurement of the daily drainage by NGT
timeFrame: Daily for the duration of the study
measure: Number of days with no vomiting episodes
timeFrame: For the duration of the study
measure: Number of daily nausea episodes
timeFrame: Daily for the duration of the study
measure: Intensity of abdominal pain
timeFrame: Daily for the duration of the study
measure: Well-being
timeFrame: Daily for the duration of the study
measure: Symptom relief duration
timeFrame: Between the first day of clinical response and the end of follow-up
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique Universitaire St. LUC
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Hermalle-sous-Huy
country: Belgium
facility: Clinique Notre-Dame
city: La Louvière
country: Belgium
facility: Centre Hospitalier de Jolimont-Lobbes
city: Amiens
country: France
facility: Hôpital Nord
city: Angers
country: France
facility: Clinique de l'Anjou
city: Angers
country: France
facility: Hôtel-Dieu
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Caen
country: France
facility: Centre François Baclesse
city: Cebazat
country: France
facility: Hôpital Nord
city: Chatenay-Malabry
country: France
facility: Clinique de l'Amandier
city: Clermont-Ferrand
country: France
facility: Hôpital Hôtel-Dieu
city: Clichy
country: France
facility: Hôpital Beaujon
city: Colmar
country: France
facility: Hôpital Pasteur
city: Compiegne
country: France
facility: Centre Hospitalier de Compiègne
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Dreux
country: France
facility: Centre Hospitalier Victor Jousselin
city: Hyeres
country: France
facility: Clinique Sainte Marguerite
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental
city: Le Chesnay
country: France
facility: Hôpital André Mignot
city: Levallois-Perret
country: France
facility: Hôpital Notre-Dame du Perpétuel Secours
city: Limoges
country: France
facility: CHU Dupuytren
city: Lorient
country: France
facility: Hôpital Site de Lorient
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Nice
country: France
facility: Hôpital de l'Archet 2
city: Orléans
country: France
facility: Hôpital de la Source
city: Osny
country: France
facility: Centre de Radiothérapie et Oncologie Médicale
city: Paris
country: France
facility: Hôpital du Val de Grâce
city: Paris
country: France
facility: Institue Curie
city: Paris
country: France
facility: Hôpital des Diaconesses
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôtel Dieu
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Georges Pompidou
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Roanne
country: France
facility: Centre Hospitalier de Roanne
city: Rouen
country: France
facility: CAC Becquerel
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Etienne
country: France
facility: Institut de Cancérologie de la Loire
city: Saint-Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Saint-Doulchard
country: France
facility: Clinique Guillaume de Varye
city: Sens
country: France
facility: Centre Hospitalier Gaston Ramon
city: Strasbourg
country: France
facility: Hôpital Civil
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Thionville
country: France
facility: C.H.R. de Metz-Thionville
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Toulouse
country: France
facility: Hôpital Joseph Ducuing
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L. Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2012 Dec 10;30(35):4337-43. doi: 10.1200/JCO.2011.40.5712. Epub 2012 Oct 29.