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

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ClinicalTrials.gov Identifier: NCT00216372
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 29, 2009
Sponsor:
Information provided by:
Ipsen

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : September 2003
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216372


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

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)
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by Ipsen:
carcinomatosis

Additional relevant MeSH terms:
Carcinoma
Peritoneal Neoplasms
Intestinal Obstruction
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs