Back to results

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

Primary Purpose

Liver Cancer, Metastatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

capecitabine

yttrium Y 90 glass microspheres

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring advanced adult primary liver cancer, liver metastases, adult primary cholangiocellular carcinoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1 (capecitabine, Y90)

Cohort 2 (capecitabine , Y90)

Cohort 3 (capecitabine, Y90)

Cohort 4 (capecitabine, Y90)

Arm Description

2,000mg/m2 capecitabine +110 Y90

2,000mg/m2 capecitabine + 130 Y90

2,000mg/m2 Capecitabine + 150 Y90

2,000 mg/m2 capecitabine = 170 Y90

Outcomes

Primary Outcome Measures

Maximal tolerated dose of yttrium Y 90

Toxicity profile of yttrium Y 90

Toxicity will be defined as number of adverse events related to treatment experienced during treatment

Time to tumor progression

Secondary Outcome Measures

Full Information

NCT ID

NCT00858429

First Posted

March 6, 2009

Last Updated

September 5, 2019

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT00858429

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 1, 2009 (Actual)

Primary Completion Date

March 19, 2014 (Actual)

Study Completion Date

July 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer, Metastatic Cancer

Keywords

advanced adult primary liver cancer, liver metastases, adult primary cholangiocellular carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 (capecitabine, Y90)

Arm Type

Experimental

Arm Description

2,000mg/m2 capecitabine +110 Y90

Arm Title

Cohort 2 (capecitabine , Y90)

Arm Type

Experimental

Arm Description

2,000mg/m2 capecitabine + 130 Y90

Arm Title

Cohort 3 (capecitabine, Y90)

Arm Type

Experimental

Arm Description

2,000mg/m2 Capecitabine + 150 Y90

Arm Title

Cohort 4 (capecitabine, Y90)

Arm Type

Experimental

Arm Description

2,000 mg/m2 capecitabine = 170 Y90

Intervention Type

Drug

Intervention Name(s)

capecitabine

Other Intervention Name(s)

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

Intervention Description

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

Radiation

Intervention Name(s)

yttrium Y 90 glass microspheres

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximal tolerated dose of yttrium Y 90

Time Frame

During treatment and any time up to 6 weeks post-treatment

Title

Toxicity profile of yttrium Y 90

Description

Toxicity will be defined as number of adverse events related to treatment experienced during treatment

Time Frame

During treatment and up to 30 days post-treatment

Title

Time to tumor progression

Time Frame

At time of disease progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Mulcahy, MD

Organizational Affiliation

Robert H. Lurie Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs