Pilot study of SIR-Spheres plus systemic chemotherapy with irinotecan alone in patients with non-resectable liver metastases from primary adenocarcinoma of the large bowel

Phase 1

Active, not recruiting

• Conditions: Metastatic colorectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12606000009516
• Lead Sponsor: Sirtex Medical Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity[Assessed over the duration of treatment and up to 1 month after the conclusion of protocol chemotherapy using UICC criteria];Response Rate[Assessed up until the scan following the completion of protocol chemotherapy]

Secondary Outcome Measures

Name	Time	Method
Time to progressive disease[];Site of Progressive Disease[];Survival[]