None listed
Conditions
Interventions
This multi-centre dose escalation study is designed to assess the safety and efficacy of a single implant of SIR-Spheres when given in combination with the first line chemotherapy combination consisting of irinotecan, 5-fluorouracil and leucovorin. The chemotherapy will be administered on weeks 1 and 2 of a 3 week cycle and given for 3 cycles. The irinotecan will then be escalated to the standard dose and an additional 6 cycles of chemotherapy will be administered.
Sponsors
Sirtex Medical Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically confirmed primary adenocarcinoma of the large bowelCT evidence of metastases in the liverLiver metastases not treatable by some form of local ablation. Prior treatment with 5FU based chemotherapy permissible for the irinotecan alone armAdequate haematological, renal and hepatic functionWHO performance status 0-2Willing and able to provide written informed consent.
Exclusion criteria
Pregnant or breast feedingEvidence of ascites, cirrhosis or portal hypertension as determined by clinical assessmentCNS metastasesPrevious radiotherapy to the liverimmeasurable or unevaluable metastases to the liverHepatic arterial anatomy that will prevent administration of SIR-Spheres>20% atreriovenous lung shuntingTreatment with capecitabine within 8 weeks of SIRT.
Outcome results
None listed