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 I/II study to test safety and efficacy of SIR-Spheres plus systemic chemotherapy with irinotecan in patients with non-resectable liver metastases from primary adenocarcinoma of the large bowel.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000009516

Enrollment

Registered

2006-01-04

Start date

2001-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

This dose escalation study is designed to assess the safety and efficacy of a single dose of SIR-Spheres when used in combination with irinotecan over a 9 treatment cycle duration. Each 3 week cycle of treatment with irinotecan on days 1 and 8 followed by a rest week on day 15.

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

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