Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases

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Northwestern University

Status and phase

Completed
Phase 1

Conditions

Metastatic Cancer
Liver Cancer

Treatments

Drug: capecitabine
Radiation: yttrium Y 90 glass microspheres

Study type

Interventional

Funder types

Other

Identifiers

NCT00858429
NCI-2009-01122 (Other Identifier)
NU 08I5
NU-08I5
STU00007062

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 4 patient groups

Cohort 1 (capecitabine, Y90)
Experimental group
Description:
2,000mg/m2 capecitabine +110 Y90
Treatment:
Radiation: yttrium Y 90 glass microspheres
Drug: capecitabine
Cohort 2 (capecitabine , Y90)
Experimental group
Description:
2,000mg/m2 capecitabine + 130 Y90
Treatment:
Radiation: yttrium Y 90 glass microspheres
Drug: capecitabine
Cohort 3 (capecitabine, Y90)
Experimental group
Description:
2,000mg/m2 Capecitabine + 150 Y90
Treatment:
Radiation: yttrium Y 90 glass microspheres
Drug: capecitabine
Cohort 4 (capecitabine, Y90)
Experimental group
Description:
2,000 mg/m2 capecitabine = 170 Y90
Treatment:
Radiation: yttrium Y 90 glass microspheres
Drug: capecitabine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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