Study investigating efficacy of a medicine lanreotide on decrease of chemotherapy induced diarrhoea (CID) in patiens with cancer of colon and rectum.

Phase 1

• Conditions: Chemotherapy induced diarrhoea that is resistant to common treatment including loperamide in patients with colorectal carcinoma; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004473-16-CZ
• Lead Sponsor: Masarykuv onkologický ústav

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-17
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1Pacient with histologically verified colorectal carcinoma.
2Pacient treated by chemotherapy based on 5-FU, capecitabine or irinotecan in adjuvant or paliative indication. This includes regimens: FUFA Mayo, FUFA DeGramont, FOLFOX, FOLFIRI, bolus regimens with 5-FU and oxaliplatine or irinotecan, monotherapy by 5-FU, capecitabine or irinotecan. Combination of chemotherapy and targeted therapy is allowed (bevacizumab, cetuximab, panitumumab).
3Patients with CID grade =3 according the CTCAE classification version 4.03 (increase of number of stools of more than 7 per day against the entry state, incontinence, if the diarrhoea and its complications are the reason for hospitalisation, significant increase of bowel movements by colonostomy against the entry state, diarrhoea inducing limitation of independence in common everyday activities).
Note: Patients with colonostomy who receive enteral alimentation can be enrolled.
4CID resistant to diet and common medication which should include loperamide. This resistance is defined as a persisting diarrhoea grade =3 after 24-hours treatment by loperamide, the maximum dose allowed 8cps/day. In the first treatment line of CID also other common medication can be used (diphenoxylate, atropine, carbo medicinalis).
5Age =18 years and =80 years.
6Patients with PS WHO =3 with anticipated survival at least 3 months.
7Patients understands the informed consent and signs it.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1CID during concomitant chemoradiotherapy.
2Somatostatine analogs used for treatment of the current CID. Previous medication by short-acting somatostatine analogs or long-acting somatostatine analogs is allowed.
3Patients with proven or suspected chronic irradiation enteritis.
4Known allergy to Somatuline Autogel 60mg, 90mg or 120mg nor another somatostatine analogs.
5Anamnesis of acute or chronic enteritis, malabsorption syndrome or idiopatic bowel inflammation (Crohn's disease, ulcerative collitis).
6Bowel fistula, short bowel syndrome.
7Anamnesis of cholecystitis in cholecystolithiasis, if cholecystectomy have not been performed.
8Serious hepatic disease. Values of liver function parameters (bilirubin, ALT, AST, GGT, ALP) >3 fold of maximum normal values.
9Diarrhoea (= grade 2) or bowel incontinence from another reasons than CID (e.g. epidemiological anamnesis, dietary error).
10Pregnancy or breastfeeding (exluded by anamnesis)
11Patients who participated in some other clinical study - during 30 days prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified