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

Phase 1
18 Years
Open (Enrolling)
Liver Cancer, Metastatic Cancer

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Trial Information

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
course 2.

After completion of study therapy, patients are followed every 3 months for 2 years.

Inclusion Criteria


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal tolerated dose of yttrium Y 90

Outcome Time Frame:

During treatment and any time up to 6 weeks post-treatment

Safety Issue:


Principal Investigator

Mary Mulcahy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Food and Drug Administration

Study ID:

NU 08I5



Start Date:

March 2009

Completion Date:

December 2015

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • advanced adult primary liver cancer
  • liver metastases
  • adult primary cholangiocellular carcinoma
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Cholangiocarcinoma



Northwestern UniversityChicago, Illinois  60611