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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00216372

Enrollment

Registered

2005-09-22

Start date

2003-09-30

Completion date

2008-10-31

Last updated

2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Intestinal Obstruction, Peritoneal Neoplasms

Keywords

carcinomatosis

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.

Interventions

DRUGLanreotide (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.

OTHERPlacebo

A single intra-muscular injection on day 0.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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)	On day 7 (plus 1 day at the latest) after the first injection

Secondary

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

Countries

Belgium, France, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026