Chemo-Therapy Induced Diarrhea
Conditions
Interventions
Trade Name: Sandostatine Long Acting Repeatable
Product Name: Sandostatin LAR
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: octreotide acetate
CAS Number: 83150-76-9
Co
Sponsors
University Hospital Gent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient should be Sandostatin® or SSA naïve for at least 3 months prior to study entry (in the therapeutic phase). However, Sandostatin® s.c. is allowed after administration of the full dose chemotherapy as rescue medication. Once the first Sandostatin® LAR® is administered in the protocol, Sandostatin®s.c. is no longer needed. • Patient with histologically proven malignancy treated with chemotherapy and experiencing a more than or equal to grade II diarrhea • All chemotherapeutic regimens administered two or three weekly with or without biotherapies are allowed. (Examples of regimens chemotherapy associated with a = 40 % grade II diarrhea are provided in Appendix 1). • Prior chemotherapy is allowed, even with diarrhoea • Older than 18 years • Written informed consent given • Performance status ECOG less or equal than 2 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient with infectious diarrhea or severe irritable bowel or inflammatory bowel disease • HIV positive patients • Biotherapies alone • Patient with known allergic reaction or hypersensitivity to Sandostatin® or SSA analogues • Symptomatic cholecystolithiasis • Uncontrolled diabetes • Female patients who are lactating or child bearing potential without adequate contraceptive measures • Patients who were included in another study protocol less than 30 days before entering this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the effectiveness of Sandostatin® LAR® in secondary prevention and to study the ability of Sandostatin® LAR® to keep the optimal dosing of planned chemotherapy by preventing the incidence of severe and/or life-threatening diarrhea. This is expressed as the fraction of patients who have received at least a second injection of Sandostatin® LAR® and who develop a less than grade II diarrhea after having received a second subsequent full dose chemotherapy to the number of patients who have received a first injection of Sandostatin® LAR® and who develop a less than grade II diarrhea after the administration of a low dose chemotherapy.;Secondary Objective: • To determine the incidence of chemotherapy induced diarrhea. • To determine the incidence of screening failures. • To determine the incidence of treatment failures. • To determine the impact of prevention. ;Primary end point(s): To determine the number of patients who have received a second injection of Sandostatin® LAR® in secondary prevention and who develop a less than grade II diarrhea after returning to full dose chemotherapy. | — |
Countries
Belgium
Outcome results
None listed