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

This study has been completed.
Sponsor:
Collaborator:
Sirtex Medical
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00604409
First received: December 28, 2007
Last updated: September 3, 2015
Last verified: September 2015
  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: 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 ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: response rate ]

Enrollment: 34
Study Start Date: April 2006
Study Completion Date: January 2015
Primary Completion Date: June 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.
  Eligibility

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
  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 ClinicalTrials.gov identifier: 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
  More Information

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 )
Study First Received: December 28, 2007
Last Updated: September 3, 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

ClinicalTrials.gov processed this record on June 26, 2017