Overview

Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg. (A responder patient will be defined either as a patient experiencing < or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days) The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28 Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication In between the visits, the patient will keep and fill out his diary and VAS scale
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Ghent
Treatments:
Angiopeptin
Lanreotide
Somatostatin
Criteria
Inclusion Criteria:

- PIC

- >= 18 years at time of enrolment

- Diagnosis of a digestive obstruction of malignant origin

- Diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3
months

- Inoperability as decided after surgical consultation

Exclusion Criteria:

- Operable obstruction

- Bowel obstruction that can be explained by a non malignant cause

- Signs of bowel obstruction

- Prior treatment with somatostatin analogues within the previous 60 days

- Known hypersensitivity to any of the test materials or related compounds

- Previous enrolment in this study