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

November 4, 2020 updated by: Ipsen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Institut Jules Bordet
      • Bruxelles, Belgium
        • Clinique Universitaire St. Luc
      • Hermalle-sous-Huy, Belgium
        • Clinique Notre-Dame
      • La Louvière, Belgium
        • Centre Hospitalier de Jolimont-Lobbes
  • France
      • Amiens, France
        • Hopital Nord
      • Angers, France
        • Clinique de l'Anjou
      • Angers, France
        • Hôtel-Dieu
      • Argenteuil, France, 95100
        • CH Victor Dupouy
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Brest, France, 29609
        • Hopital De La Cavale Blanche
      • Caen, France
        • Centre Francois Baclesse
      • Cebazat, France, 63118
        • Hopital Nord
      • Chatenay-Malabry, France
        • Clinique de l'Amandier
      • Clermont-Ferrand, France
        • Hôpital Hôtel-Dieu
      • Clichy, France, 92118
        • Hopital Beaujon
      • Colmar, France
        • Hopital PASTEUR
      • Compiegne, France, 60321
        • Centre Hospitalier de Compiegne
      • Creteil, France, 94000
        • Hopital Henri Mondor
      • Dreux, France, 28102
        • Centre Hospitalier Victor Jousselin
      • Hyeres, France
        • Clinique Sainte Marguerite
      • La Roche sur Yon, France
        • Centre Hospitalier departemental
      • Le Chesnay, France, 78150
        • Hôpital André Mignot
      • Levallois-Perret, France, 92309
        • Hôpital Notre-Dame du Perpétuel Secours
      • Limoges, France, 87042
        • Chu Dupuytren
      • Lorient, France
        • Hôpital Site de Lorient
      • Lyon, France
        • Hopital de La Croix Rousse
      • Nice, France
        • Hopital de l'archet 2
      • Orléans, France
        • Hôpital de la Source
      • Osny, France
        • Centre de Radiothérapie et Oncologie Médicale
      • Paris, France, 75651
        • Hopital Pitie Salpetriere
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75012
        • Hôpital des Diaconesses
      • Paris, France, 75181
        • Hotel Dieu
      • Paris, France, 75005
        • Hôpital du Val de Grâce
      • Paris, France, 75005
        • Institue Curie
      • Paris, France
        • Hopital Georges Pompidou
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Reims, France
        • Institut Jean Godinot
      • Rennes, France
        • Centre Eugene Marquis
      • Roanne, France
        • Centre Hospitalier de Roanne
      • Rouen, France
        • Hopital Charles Nicolle
      • Rouen, France, 76038
        • CAC Becquerel
      • Saint Etienne, France, 42020
        • Institut de Cancerologie de La Loire
      • Saint-Brieuc, France, 22015
        • Clinique Armoricaine de Radiologie
      • Saint-Doulchard, France
        • Clinique Guillaume De Varye
      • Sens, France, 89108
        • Centre Hospitalier Gaston Ramon
      • Strasbourg, France, 67091
        • Hôpital Civil
      • Strasbourg, France
        • Hôpital Hautepierre
      • Thionville, France, 57126
        • C.H.R. de Metz-Thionville
      • Toulouse, France
        • Hôpital Joseph Ducuing
      • Toulouse, France
        • Hopital de Rangueil
      • Villejuif, France
        • Institut Gustave Roussy
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Placebo Comparator: 2
Other: Placebo
A single intra-muscular injection on day 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: On day 7 (plus 1 day at the latest) after the first injection
On day 7 (plus 1 day at the latest) after the first injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of daily vomiting episodes or measurement of the daily drainage by NGT
Time Frame: Daily for the duration of the study
Daily for the duration of the study
Number of days with no vomiting episodes
Time Frame: For the duration of the study
For the duration of the study
Number of daily nausea episodes
Time Frame: Daily for the duration of the study
Daily for the duration of the study
Intensity of abdominal pain
Time Frame: Daily for the duration of the study
Daily for the duration of the study
Well-being
Time Frame: Daily for the duration of the study
Daily for the duration of the study
Symptom relief duration
Time Frame: Between the first day of clinical response and the end of follow-up
Between the first day of clinical response and the end of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-54-52030-156 (408)
  • 2005-002349-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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