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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00216372
First received: September 13, 2005
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Intestinal Obstruction
Carcinoma
Peritoneal Neoplasms
Drug: Lanreotide (microparticle formulation)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

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) [ Time Frame: On day 7 (plus 1 day at the latest) after the first injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of daily vomiting episodes or measurement of the daily drainage by NGT [ Time Frame: Daily for the duration of the study ] [ Designated as safety issue: No ]
  • Number of days with no vomiting episodes [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • Number of daily nausea episodes [ Time Frame: Daily for the duration of the study ] [ Designated as safety issue: No ]
  • Intensity of abdominal pain [ Time Frame: Daily for the duration of the study ] [ Designated as safety issue: No ]
  • Well-being [ Time Frame: Daily for the duration of the study ] [ Designated as safety issue: No ]
  • Symptom relief duration [ Time Frame: Between the first day of clinical response and the end of follow-up ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216372

  Show 53 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Sandrine Lewin Ipsen
  More Information

No publications provided by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandrine Lewin, Ipsen
ClinicalTrials.gov Identifier: NCT00216372     History of Changes
Other Study ID Numbers: 2-54-52030-156 (408)
Study First Received: September 13, 2005
Last Updated: May 28, 2009
Health Authority: France: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Belgium: Institutional Review Board

Keywords provided by Ipsen:
carcinomatosis

Additional relevant MeSH terms:
Intestinal Obstruction
Peritoneal Neoplasms
Abdominal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Neoplasms
Neoplasms by Site
Peritoneal Diseases
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014