Yttrium Y 90 Glass Microspheres and 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.

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

• Intrahepatic cholangiocarcinoma
• Metastatic cancer confined to the liver
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• Must have tumor volume ≤ 50% of total liver volume based on visual estimation

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm^3
• Serum creatinine ≤ 2.0 mg/dL
• Serum bilirubin ≤ 1.5 times upper limit of normal
• Albumin ≥ 2.0 g/dL
• No baseline symptoms or laboratory values > grade 2 in severity by NCI CTCAE v 3.0 criteria
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No malabsorption syndrome
• No severe liver dysfunction or pulmonary insufficiency
• No complete occlusion of the main portal vein
• No contraindication to iodine-based contrast agents
• No contraindication to hepatic artery catheterization (e.g., vascular abnormalities or bleeding diathesis)
• No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to the liver
• No more than 2 prior therapies for metastatic disease to the liver
• No prior intervention to or compromise of the Ampulla of Vater
• At least 4 weeks since prior and no concurrent sorivudine or brivudine
• No concurrent cimetidine