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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858429
• Other study ID #: NU 08I5
• Secondary ID: NU-08I5STU000070
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2009
• Est. completion date: July 8, 2014

Study information

• Verified date: January 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 8, 2014
• Est. primary completion date: March 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Liver Cancer
• Liver Neoplasms
• Metastatic Cancer

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal tolerated dose of yttrium Y 90		During treatment and any time up to 6 weeks post-treatment
Primary	Toxicity profile of yttrium Y 90	Toxicity will be defined as number of adverse events related to treatment experienced during treatment	During treatment and up to 30 days post-treatment
Primary	Time to tumor progression		At time of disease progression