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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Liver Cancer

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Trial Information

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


Patients with adequate liver function and performance status in whom liver-directed therapy
and capecitabine would be appropriate are eligible for this clinical trial.


Inclusion Criteria:



- Adequate liver function

- Adequate performance status

Exclusion Criteria:

- Significant extrahepatic disease

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer.

Outcome Time Frame:

ongoing

Safety Issue:

Yes

Principal Investigator

Steven J. Cohen, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

FCCC04043

NCT ID:

NCT00604409

Start Date:

April 2006

Completion Date:

December 2013

Related Keywords:

  • Metastatic Liver Cancer
  • Liver Neoplasms

Name

Location
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111