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

Phase 1

Completed

• Conditions: Liver Cancer; Metastatic Cancer
• Interventions: Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres

• Registration Number: NCT00858429
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Study Start: 2009-04-01
• Primary Completion: 2014-03-19
• Study Completion: 2014-07-08
• Status Verified: 2018-01
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 4 (capecitabine, Y90)	yttrium Y 90 glass microspheres	2,000 mg/m2 capecitabine = 170 Y90
Cohort 2 (capecitabine , Y90)	yttrium Y 90 glass microspheres	2,000mg/m2 capecitabine + 130 Y90
Cohort 3 (capecitabine, Y90)	yttrium Y 90 glass microspheres	2,000mg/m2 Capecitabine + 150 Y90
Cohort 1 (capecitabine, Y90)	yttrium Y 90 glass microspheres	2,000mg/m2 capecitabine +110 Y90
Cohort 1 (capecitabine, Y90)	capecitabine	2,000mg/m2 capecitabine +110 Y90
Cohort 2 (capecitabine , Y90)	capecitabine	2,000mg/m2 capecitabine + 130 Y90
Cohort 3 (capecitabine, Y90)	capecitabine	2,000mg/m2 Capecitabine + 150 Y90
Cohort 4 (capecitabine, Y90)	capecitabine	2,000 mg/m2 capecitabine = 170 Y90

Primary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States