Chemotherapy induced diarrhoea that is resistant to common treatment including loperamide in patients with colorectal carcinoma
Conditions
Interventions
Trade Name: SOMATULINE AUTOGEL 120 MG INJ SOL 1X0.5ML/120MG
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: LANREOTIDE ACETATE
CAS Number: 127984-74-1
Other des
Sponsors
Masarykuv onkologický ústav
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Pacient with histologically verified colorectal carcinoma. 2 Pacient 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). 3 Patients 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. 4 CID 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). 5 Age =18 years and =80 years. 6 Patients with PS WHO =3 with anticipated survival at least 3 months. 7 Patients 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
Exclusion criteria: 1 CID during concomitant chemoradiotherapy. 2 Somatostatine analogs used for treatment of the current CID. Previous medication by short-acting somatostatine analogs or long-acting somatostatine analogs is allowed. 3 Patients with proven or suspected chronic irradiation enteritis. 4 Known allergy to Somatuline Autogel 60mg, 90mg or 120mg nor another somatostatine analogs. 5 Anamnesis of acute or chronic enteritis, malabsorption syndrome or idiopatic bowel inflammation (Crohn's disease, ulcerative collitis). 6 Bowel fistula, short bowel syndrome. 7 Anamnesis of cholecystitis in cholecystolithiasis, if cholecystectomy have not been performed. 8 Serious hepatic disease. Values of liver function parameters (bilirubin, ALT, AST, GGT, ALP) >3 fold of maximum normal values. 9 Diarrhoea (= grade 2) or bowel incontinence from another reasons than CID (e.g. epidemiological anamnesis, dietary error). 10 Pregnancy or breastfeeding (exluded by anamnesis) 11 Patients who participated in some other clinical study - during 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Definition of efficacy of lanreotid in the therapy of CID which is defined as a rate of regression of CID to grade G1 from the entry value (grade G3 or G4) according to CTCAE v.4.03;Secondary Objective: Secondary efficacy objectives: 1. Rate of regression of CID against the entry value – 2 grades (from G3 to G1 and from G4 to G2). 2-grades amelioration of CID is clinically significant. Usually it allows possibility of outpatient treatment without need of infusion support. 2. Monitoring of following intensity and density of chemotherapy (following of dosage and interval) 3. Influence of lanreotide treatment on quality of life (use of questionnaires EQ – 5D) Secondary safety objectives: assessment of occurence of AE –descriptive assessment of frequency of occurence, seriousness and types of all found AE. ;Primary end point(s): Paremeter of efficacy is the rate of regression of CID to grade G1 from the entry value (grade G3 or G4) during 7 days from the first administration of the investigational medicinal product.;Timepoint(s) of evaluation of this end point: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Rate of regression of CID against the entry value – 2 grades (from G3 to G1 and from G4 to G2) during 7 days from the first administration of the investigational medicinal product. 2. Compliance with intensity and density of chemotherapy (compliance with dosage and interval), asessed after the cycle of chemotherapy following the first application of lanreotide. 3. Compliance with intensity and density (compliance with dosage and interval), asessed after the last chemotherapy in this trial. 4. Quality of life -use of questionnaires EQ – 5D, assessed at the enrollment, day 7, one month after the first administration of lanreotide and two months after the first administration of lanreotide. ;Timepoint(s) of evaluation of this end point: 1. During 7 days from the first administration of the investigational medicinal product. 2. Assessed after the cycle of chemotherapy following the first application of lanreot 3. Asessed after the last chemotherapy in this trial. 4. Assessed at the enrollment, day 7, one month after the first administration of lanreotide and two months after the first administration of lanreotide. | — |
Countries
Czech Republic
Contacts
Public ContactOddelení klinických hodnocení
Masarykuv onkologický ústav
Outcome results
None listed