Sandostatin LAR in prevention of Chemotherapy Induced Diarrhea

niversity Hospital Gent0 个研究点开始时间: 2006年8月8日最近更新: 2014年10月7日

试验速览

暂无简介。

•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

•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

发起方

niversity Hospital Gent