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OpenTrials
Completed

NCT Number: NCT00216372

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

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.

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Key information

Conditions

Intestinal Obstruction Abdominal Neoplasms Carcinoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Intestinal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinique Universitaire St. LUC, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanreotide (microparticle formulation)

Drug

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

Other

A single intra-muscular injection on day 0.

Primary outcomes

  1. 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 outcomes

  1. Number of daily vomiting episodes or measurement of the daily drainage by NGT

    Time frame: Daily for the duration of the study

  2. Number of days with no vomiting episodes

    Time frame: For the duration of the study

  3. Number of daily nausea episodes

    Time frame: Daily for the duration of the study

  4. Intensity of abdominal pain

    Time frame: Daily for the duration of the study

  5. Well-being

    Time frame: Daily for the duration of the study

  6. Symptom relief duration

    Time frame: Between the first day of clinical response and the end of follow-up

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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