Metastatic Cancer Clinical Trial
Official title:
Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that
deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause
less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Capecitabine may also make tumor cells more sensitive to radiation
therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass
microspheres when given together with capecitabine in treating patients with liver
cholangiocarcinoma or liver metastases.
OBJECTIVES:
- Establish the maximally tolerated dose of yttrium Y 90 glass microspheres in combination
with capecitabine in patients with intrahepatic cholangiocarcinoma or liver metastases.
- 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
course 2.
After completion of study therapy, patients are followed every 3 months for 2 years.
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