Clinical trial NCT01076803: Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
Official title: Prospective Study to Assess the Efficacy and Safety of Lanreotide 120 mg as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Intestinal Obstruction
Keywords: Malignant intestinal obstruction in inoperable patients
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Percentage of responder patients.
timeFrame: At day 7 and day 14.
Secondary outcomes:
measure: Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT).
timeFrame: day 7, day 14 and day 28 after administration of Lanreotide
measure: Number of days without vomiting episodes
timeFrame: day 7, day 14 and day 28 after administration of Lanreotide
measure: Number of daily nausea episodes recorded on diary cards.
timeFrame: day 7, day 14 and day 28 after administration of Lanreotide
measure: Intensity of abdominal pain assessed on a visual analogue scale.
timeFrame: day 7, day 14 and day 28 after administration of Lanreotide.
measure: Well-being assessed on a visual analogue scale.
timeFrame: day 7, day 14 and day 28 after administration of Lanreotide.
measure: Time between first injection and clinical response.
timeFrame: day 7, day 14 and day 28 after administration of Lanreotide
measure: Clinical and biological adverse events.
timeFrame: day 7, day 14 and day 28 after administration of Lanreotide.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Karen Geboes, MD
role: PRINCIPAL_INVESTIGATOR
References: