Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver
- Establish the maximally tolerated dose of yttrium Y 90 glass microspheres in
combination with capecitabine in patients with intrahepatic cholangiocarcinoma or liver
- Characterize the toxicity of this regimen in these patients.
- Determine the time to tumor progression in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days
for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also
receive yttrium Y 90 glass microspheres by intra-arterial hepatic infusion on days 1-7 of
After completion of study therapy, patients are followed every 3 months for 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximal tolerated dose of yttrium Y 90
During treatment and any time up to 6 weeks post-treatment
Mary Mulcahy, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Northwestern University||Chicago, Illinois 60611|