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

This study is currently recruiting participants.
Verified January 2013 by Fox Chase Cancer Center
Sponsor:
Collaborator:
Sirtex Medical
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00604409
First received: December 28, 2007
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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 2013
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

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

Inclusion Criteria:

  • Adequate liver function
  • Adequate performance status

Exclusion Criteria:

  • Significant extrahepatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604409

Contacts
Contact: Steven J. Cohen, M.D. 215-728-2450 S_Cohen@fccc.edu

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
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
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00604409     History of Changes
Other Study ID Numbers: FCCC04043, NCI-2010-01936
Study First Received: December 28, 2007
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013