Trial | NCT00604409  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    34
This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.
Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.
Study Started
Apr 30
2006
Primary Completion
Jun 30
2014
Study Completion
Jan 31
2015
Last Update
Sep 07
2015
Estimate

Radiation SIRT

Undergo SIRT

  • Other names: selective internal radiation therapy

Drug capecitabine

Given PO

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

Treatment (SIRT and capecitabine) Experimental

Patients receive capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo SIRT on day 2 and may undergo a second course of SIRT on day 58.

Criteria 

Inclusion Criteria:

Adequate liver function
Adequate performance status

Exclusion Criteria:

Significant extrahepatic disease
No Results Posted