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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Malignant Intestinal Obstruction

Treatments: Drug: Lanreotide (acetate)

Study type: Interventional

Funder types: Other

Identifiers

NCT01076803

2009/289

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Lanreotide (acetate)

Experimental group

Treatment:

Drug: Lanreotide (acetate)