Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver

Inclusion Criteria

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