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

NCT ID: NCT00858429

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-01
• Study Completion Date: 2014-07-08

Brief 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.

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.

Conditions

Liver Cancer; Metastatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (capecitabine, Y90)

2,000mg/m2 capecitabine +110 Y90

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.

yttrium Y 90 glass microspheres

Intervention Type: RADIATION

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.

Cohort 2 (capecitabine , Y90)

2,000mg/m2 capecitabine + 130 Y90

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.

yttrium Y 90 glass microspheres

Intervention Type: RADIATION

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.

Cohort 3 (capecitabine, Y90)

2,000mg/m2 Capecitabine + 150 Y90

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.

yttrium Y 90 glass microspheres

Intervention Type: RADIATION

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.

Cohort 4 (capecitabine, Y90)

2,000 mg/m2 capecitabine = 170 Y90

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.

yttrium Y 90 glass microspheres

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

C14H15FN3O7; prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR)

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Mary Mulcahy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Mulcahy, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-08I5

Identifier Type: -

Identifier Source: secondary_id

STU00007062

Identifier Type: -

Identifier Source: secondary_id

NCI-2009-01122

Identifier Type: OTHER

Identifier Source: secondary_id

NU 08I5

Identifier Type: -

Identifier Source: org_study_id