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

Temple University Health System (TUHS)

Status and phase: Completed; Phase 1

Conditions: Metastatic Liver Cancer

Treatments: Drug: capecitabine; Radiation: SIRT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00604409

FCCC04043

NCI-2010-01936 (Registry Identifier)

Details and patient eligibility

About

This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adequate liver function
• Adequate performance status

Exclusion criteria

• Significant extrahepatic disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Treatment (SIRT and capecitabine)

Experimental group

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.

Treatment:

Radiation: SIRT

Drug: capecitabine