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

This study is currently recruiting participants.
Verified February 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Mary Mulcahy, Northwestern University
ClinicalTrials.gov Identifier:
NCT00858429
First received: March 6, 2009
Last updated: February 10, 2014
Last verified: February 2014

March 6, 2009
February 10, 2014
March 2009
December 2014   (final data collection date for primary outcome measure)
  • Maximal tolerated dose of yttrium Y 90 [ Time Frame: During treatment and any time up to 6 weeks post-treatment ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: During treatment and up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Time to tumor progression [ Time Frame: At time of disease progression ] [ Designated as safety issue: No ]
  • Maximal tolerated dose of yttrium Y 90 [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to tumor progression [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00858429 on ClinicalTrials.gov Archive Site
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Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cancer
  • Metastatic Cancer
  • Drug: capecitabine
    1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.
    Other Names:
    • C14H15FN3O7
    • prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR)
  • Radiation: yttrium Y 90 glass microspheres
    The amount of radioactivity required to deliver the desired dose to the liver is calculated using a formula. The dose depends on the cohort upon which the patient is enrolled. Y90 is administered during Cycle #2 on days 1-7.
  • Experimental: Cohort 1 (capecitabine, Y90)
    2,000mg/m2 capecitabine +110 Y90
    Interventions:
    • Drug: capecitabine
    • Radiation: yttrium Y 90 glass microspheres
  • Experimental: Cohort 2 (capecitabine , Y90)
    2,000mg/m2 capecitabine + 130 Y90
    Interventions:
    • Drug: capecitabine
    • Radiation: yttrium Y 90 glass microspheres
  • Experimental: Cohort 3 (capecitabine, Y90)
    2,000mg/m2 Capecitabine + 150 Y90
    Interventions:
    • Drug: capecitabine
    • Radiation: yttrium Y 90 glass microspheres
  • Experimental: Cohort 4 (capecitabine, Y90)
    2,000 mg/m2 capecitabine = 170 Y90
    Interventions:
    • Drug: capecitabine
    • Radiation: yttrium Y 90 glass microspheres
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mary Mulcahy, MD 312-695-4440 m-mulcahy@northwestern.edu
United States
 
NCT00858429
NU 08I5, NU-08I5, STU00007062, NCI-2009-01122
Yes
Mary Mulcahy, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center
Northwestern University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP