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

Primary Purpose

Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lanreotide (microparticle formulation)
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Obstruction focused on measuring carcinomatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Universitaire St. LUC
  • Institut Jules Bordet
  • Clinique Notre-Dame
  • Centre Hospitalier de Jolimont-Lobbes
  • Hôpital Nord
  • Clinique de l'Anjou
  • Hôtel-Dieu
  • CH Victor Dupouy
  • Hôpital Saint André
  • Hôpital de la Cavale Blanche
  • Centre François Baclesse
  • Hôpital Nord
  • Clinique de l'Amandier
  • Hôpital Hôtel-Dieu
  • Hôpital Beaujon
  • Hôpital Pasteur
  • Centre Hospitalier de Compiègne
  • Hôpital Henri Mondor
  • Centre Hospitalier Victor Jousselin
  • Clinique Sainte Marguerite
  • Centre Hospitalier Départemental
  • Hôpital André Mignot
  • Hôpital Notre-Dame du Perpétuel Secours
  • CHU Dupuytren
  • Hôpital Site de Lorient
  • Hôpital de la Croix Rousse
  • Hôpital de l'Archet 2
  • Hôpital de la Source
  • Centre de Radiothérapie et Oncologie Médicale
  • Hôpital du Val de Grâce
  • Institue Curie
  • Hôpital des Diaconesses
  • Hôpital Saint Antoine
  • Hôtel Dieu
  • Hôpital Pitié Salpêtrière
  • Hôpital Georges Pompidou
  • Centre Hospitalier Lyon Sud
  • Institut Jean Godinot
  • Centre Eugène Marquis
  • Centre Hospitalier de Roanne
  • CAC Becquerel
  • Hôpital Charles Nicolle
  • Institut de Cancérologie de la Loire
  • Clinique Armoricaine de Radiologie
  • Clinique Guillaume de Varye
  • Centre Hospitalier Gaston Ramon
  • Hôpital Civil
  • Hôpital Hautepierre
  • C.H.R. de Metz-Thionville
  • Hôpital de Rangueil
  • Hôpital Joseph Ducuing
  • Institut Gustave Roussy
  • Academisch Medisch Centrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of daily vomiting episodes or measurement of the daily drainage by NGT
Number of days with no vomiting episodes
Number of daily nausea episodes
Intensity of abdominal pain
Well-being
Symptom relief duration

Full Information

First Posted
September 13, 2005
Last Updated
November 4, 2020
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00216372
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms
Keywords
carcinomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lanreotide (microparticle formulation)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A single intra-muscular injection on day 0.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of daily vomiting episodes or measurement of the daily drainage by NGT
Time Frame
Daily for the duration of the study
Title
Number of days with no vomiting episodes
Time Frame
For the duration of the study
Title
Number of daily nausea episodes
Time Frame
Daily for the duration of the study
Title
Intensity of abdominal pain
Time Frame
Daily for the duration of the study
Title
Well-being
Time Frame
Daily for the duration of the study
Title
Symptom relief duration
Time Frame
Between the first day of clinical response and the end of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Clinique Universitaire St. LUC
City
Bruxelles
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
Country
Belgium
Facility Name
Clinique Notre-Dame
City
Hermalle-sous-Huy
Country
Belgium
Facility Name
Centre Hospitalier de Jolimont-Lobbes
City
La Louvière
Country
Belgium
Facility Name
Hôpital Nord
City
Amiens
Country
France
Facility Name
Clinique de l'Anjou
City
Angers
Country
France
Facility Name
Hôtel-Dieu
City
Angers
Country
France
Facility Name
CH Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre François Baclesse
City
Caen
Country
France
Facility Name
Hôpital Nord
City
Cebazat
ZIP/Postal Code
63118
Country
France
Facility Name
Clinique de l'Amandier
City
Chatenay-Malabry
Country
France
Facility Name
Hôpital Hôtel-Dieu
City
Clermont-Ferrand
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hôpital Pasteur
City
Colmar
Country
France
Facility Name
Centre Hospitalier de Compiègne
City
Compiegne
ZIP/Postal Code
60321
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Hospitalier Victor Jousselin
City
Dreux
ZIP/Postal Code
28102
Country
France
Facility Name
Clinique Sainte Marguerite
City
Hyeres
Country
France
Facility Name
Centre Hospitalier Départemental
City
La Roche sur Yon
Country
France
Facility Name
Hôpital André Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Hôpital Notre-Dame du Perpétuel Secours
City
Levallois-Perret
ZIP/Postal Code
92309
Country
France
Facility Name
CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital Site de Lorient
City
Lorient
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Hôpital de l'Archet 2
City
Nice
Country
France
Facility Name
Hôpital de la Source
City
Orléans
Country
France
Facility Name
Centre de Radiothérapie et Oncologie Médicale
City
Osny
Country
France
Facility Name
Hôpital du Val de Grâce
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Institue Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital des Diaconesses
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôtel Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Georges Pompidou
City
Paris
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
Centre Hospitalier de Roanne
City
Roanne
Country
France
Facility Name
CAC Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint Etienne
ZIP/Postal Code
42020
Country
France
Facility Name
Clinique Armoricaine de Radiologie
City
Saint-Brieuc
ZIP/Postal Code
22015
Country
France
Facility Name
Clinique Guillaume de Varye
City
Saint-Doulchard
Country
France
Facility Name
Centre Hospitalier Gaston Ramon
City
Sens
ZIP/Postal Code
89108
Country
France
Facility Name
Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital Hautepierre
City
Strasbourg
Country
France
Facility Name
C.H.R. de Metz-Thionville
City
Thionville
ZIP/Postal Code
57126
Country
France
Facility Name
Hôpital de Rangueil
City
Toulouse
Country
France
Facility Name
Hôpital Joseph Ducuing
City
Toulouse
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23109694
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.
Results Reference
derived

Learn more about this trial

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

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