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
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Metastatic Cancer
Drug: capecitabine
Radiation: yttrium Y 90 glass microspheres
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 (capecitabine, Y90)
2,000mg/m2 capecitabine +110 Y90
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 2 (capecitabine , Y90)
2,000mg/m2 capecitabine + 130 Y90
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 3 (capecitabine, Y90)
2,000mg/m2 Capecitabine + 150 Y90
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 4 (capecitabine, Y90)
2,000 mg/m2 capecitabine = 170 Y90
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858429

Contacts
Contact: Mary Mulcahy, MD 312-695-4440 m-mulcahy@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Study Coordinator    312-695-1301    cancertrials@northwestern.edu   
Principal Investigator: Riad Salem, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Mary Mulcahy, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT00858429     History of Changes
Other Study ID Numbers: NU 08I5, NU-08I5, STU00007062, NCI-2009-01122
Study First Received: March 6, 2009
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
advanced adult primary liver cancer
liver metastases
adult primary cholangiocellular carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Doxifluridine
Fluorouracil
Capecitabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014