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NCT00604409 Clinical Trial

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

Metastatic Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00604409
Other study ID # FCCC04043
Secondary ID NCI-2010-01936
Status Completed
Phase Phase 1
First received December 28, 2007
Last updated September 3, 2015
Start date April 2006
Est. completion date January 2015

Study information
Verified date September 2015
Source Fox Chase Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date January 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adequate liver function

- Adequate performance status

Exclusion Criteria:

- Significant extrahepatic disease

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Radiation:
• SIRT
Undergo SIRT
Drug:
• capecitabine
Given PO

Locations
Country Name City State
United States Fox Chase Cancer Center Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Fox Chase Cancer Center Sirtex Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Efficacy response rate No
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