Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has suspended participant recruitment.
Sirtex Medical
Information provided by (Responsible Party):
Fox Chase Cancer Center Identifier:
First received: December 28, 2007
Last updated: May 1, 2014
Last verified: May 2014

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

Condition Intervention Phase
Metastatic Liver Cancer
Radiation: SIRT
Drug: capecitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Resource links provided by NLM:

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: response rate ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: April 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (SIRT and capecitabine)
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.
Radiation: SIRT
Undergo SIRT
Other Name: selective internal radiation therapy
Drug: capecitabine
Given PO
Other Name: CAPE, Ro 09-1978/000, Xeloda

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adequate liver function
  • Adequate performance status

Exclusion Criteria:

  • Significant extrahepatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00604409

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Sirtex Medical
Study Chair: Steven J. Cohen, M.D. Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center Identifier: NCT00604409     History of Changes
Other Study ID Numbers: FCCC04043, NCI-2010-01936
Study First Received: December 28, 2007
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015