Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00604409

Enrollment

Registered

2008-01-30

Start date

2006-04-30

Completion date

2015-01-31

Last updated

2015-09-07

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

Conditions

Metastatic Liver Cancer

Brief summary

This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.

Detailed description

Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.

Interventions

RADIATIONSIRT

Undergo SIRT

DRUGcapecitabine

Given PO

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adequate liver function * Adequate performance status

Exclusion criteria

* Significant extrahepatic disease

Design outcomes

Primary

Measure	Time frame
To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer.	ongoing

Secondary

Measure	Time frame
Efficacy	response rate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026