ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00604409
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : September 7, 2015
Sponsor:
Collaborator:
Sirtex Medical
Information provided by (Responsible Party):
Fox Chase Cancer Center

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

Condition or disease Intervention/treatment Phase
Metastatic Liver Cancer Radiation: SIRT Drug: capecitabine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
Study Start Date : April 2006
Actual Primary Completion Date : June 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Efficacy [ Time Frame: response rate ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adequate liver function
  • Adequate performance status

Exclusion Criteria:

  • Significant extrahepatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604409


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

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00604409     History of Changes
Other Study ID Numbers: FCCC04043
NCI-2010-01936 ( Registry Identifier: NCI Clinical Trials Reporting Office )
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents