Skip to main content
OpenTrials
Completed

NCT Number: NCT00604409

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adequate liver function
  • Adequate performance status

Exclusion criteria

  • Significant extrahepatic disease

Treatment and study plan

SIRT

Radiation

Undergo SIRT

Other names: selective internal radiation therapy

Capecitabine

Drug

Given PO

Other names: CAPE, Ro 09-1978/000, Xeloda

Primary outcomes

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

    Time frame: ongoing

Secondary outcomes

  1. Efficacy

    Time frame: response rate

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • Sirtex Medical

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2014
Study completion
2015
First posted
Jan 30, 2008
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.