Back to resultsStudy of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
Primary Purpose
Metastatic Liver Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SIRT
capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Liver Cancer
Eligibility Criteria
Inclusion Criteria:
- Adequate liver function
- Adequate performance status
Exclusion Criteria:
- Significant extrahepatic disease
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (SIRT and capecitabine)
Arm Description
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.
Outcomes
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.
Secondary Outcome Measures
Efficacy
Full Information
NCT ID
NCT00604409
First Posted
December 28, 2007
Last Updated
September 3, 2015
Sponsor
Fox Chase Cancer Center
Collaborators
Sirtex Medical
1. Study Identification
Unique Protocol Identification Number
NCT00604409
Brief Title
Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
Official Title
Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
Sirtex Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Liver Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (SIRT and capecitabine)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
SIRT
Other Intervention Name(s)
selective internal radiation therapy
Intervention Description
Undergo SIRT
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
CAPE, Ro 09-1978/000, Xeloda
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Efficacy
Time Frame
response rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adequate liver function
Adequate performance status
Exclusion Criteria:
Significant extrahepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J. Cohen, M.D.
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
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