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

This study is currently recruiting participants.

Verified by Fox Chase Cancer Center, December 2007

Sponsors and Collaborators:	Fox Chase Cancer Center Sirtex Medical
Information provided by:	Fox Chase Cancer Center
ClinicalTrials.gov Identifier:	NCT00604409

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	Device: Sir-Spheres Drug: Capecitabine	Phase I

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

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:	June 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Capecitabine plus Sir-Spheres

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

Responsible Party:	Fox Chase Cancer Center ( Steven J. Cohen, M.D. )
Study ID Numbers:	FCCC04043
Study First Received:	December 28, 2007
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00604409
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Liver Neoplasms
Capecitabine
Liver Diseases
Digestive System Diseases

Digestive System Neoplasms
Liver neoplasms
Gastrointestinal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009