Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis

Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216372
• Other study ID #: 2-54-52030-156 (408)
• Secondary ID: 2005-002349-38
• Status: Completed
• Phase: Phase 3
• Start date: September 2003
• Est. completion date: October 2008

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Intestinal Obstruction
• Peritoneal Neoplasms

Intervention

Drug:
• Lanreotide (microparticle formulation)
A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment.

Other:
• Placebo
A single intra-muscular injection on day 0.

Locations

Country	Name	City	State
Belgium	Clinique Universitaire St. LUC	Bruxelles
Belgium	Institut Jules Bordet	Bruxelles
Belgium	Clinique Notre-Dame	Hermalle-sous-Huy
Belgium	Centre Hospitalier de Jolimont-Lobbes	La Louvière
France	Hôpital Nord	Amiens
France	Clinique de l'Anjou	Angers
France	Hôtel-Dieu	Angers
France	CH Victor Dupouy	Argenteuil
France	Hôpital Saint André	Bordeaux
France	Hôpital de la Cavale Blanche	Brest
France	Centre François Baclesse	Caen
France	Hôpital Nord	Cebazat
France	Clinique de l'Amandier	Chatenay-Malabry
France	Hôpital Hôtel-Dieu	Clermont-Ferrand
France	Hôpital Beaujon	Clichy
France	Hôpital Pasteur	Colmar
France	Centre Hospitalier de Compiègne	Compiegne
France	Hôpital Henri Mondor	Creteil
France	Centre Hospitalier Victor Jousselin	Dreux
France	Clinique Sainte Marguerite	Hyeres
France	Centre Hospitalier Départemental	La Roche sur Yon
France	Hôpital André Mignot	Le Chesnay
France	Hôpital Notre-Dame du Perpétuel Secours	Levallois-Perret
France	CHU Dupuytren	Limoges
France	Hôpital Site de Lorient	Lorient
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital de l'Archet 2	Nice
France	Hôpital de la Source	Orléans
France	Centre de Radiothérapie et Oncologie Médicale	Osny
France	Hôpital des Diaconesses	Paris
France	Hôpital du Val de Grâce	Paris
France	Hôpital Georges Pompidou	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	Hôpital Saint Antoine	Paris
France	Hôtel Dieu	Paris
France	Institue Curie	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Institut Jean Godinot	Reims
France	Centre Eugène Marquis	Rennes
France	Centre Hospitalier de Roanne	Roanne
France	CAC Becquerel	Rouen
France	Hôpital Charles Nicolle	Rouen
France	Institut de Cancérologie de la Loire	Saint Etienne
France	Clinique Armoricaine de Radiologie	Saint-Brieuc
France	Clinique Guillaume de Varye	Saint-Doulchard
France	Centre Hospitalier Gaston Ramon	Sens
France	Hôpital Civil	Strasbourg
France	Hôpital Hautepierre	Strasbourg
France	C.H.R. de Metz-Thionville	Thionville
France	Hôpital de Rangueil	Toulouse
France	Hôpital Joseph Ducuing	Toulouse
France	Institut Gustave Roussy	Villejuif
Netherlands	Academisch Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		On day 7 (plus 1 day at the latest) after the first injection
Secondary	Number of daily vomiting episodes or measurement of the daily drainage by NGT		Daily for the duration of the study
Secondary	Number of days with no vomiting episodes		For the duration of the study
Secondary	Number of daily nausea episodes		Daily for the duration of the study
Secondary	Intensity of abdominal pain		Daily for the duration of the study
Secondary	Well-being		Daily for the duration of the study
Secondary	Symptom relief duration		Between the first day of clinical response and the end of follow-up