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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms

Intervention / Treatment
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* Drug: Lanreotide (microparticle formulation)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Lanreotide (microparticle formulation)<br>* 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.<br>|
| Placebo Comparator: 2<br> | Other: Placebo<br>* A single intra-muscular injection on day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of daily vomiting episodes or measurement of the daily drainage by NGT |  | Daily for the duration of the study | 
| 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 | 
| Intensity of abdominal pain |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carcinomatosis