Overview

This trial is active, not recruiting.

Conditions liver cancer, metastatic cancer
Treatments capecitabine, yttrium y 90 glass microspheres
Phase phase 1
Sponsor Northwestern University
Start date March 2009
End date December 2016
Trial size 30 participants
Trial identifier NCT00858429, NCI-2009-01122, NU 08I5, NU-08I5, STU00007062

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2,000mg/m2 capecitabine +110 Y90
capecitabine C14H15FN3O7
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
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)
2,000mg/m2 capecitabine + 130 Y90
capecitabine C14H15FN3O7
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
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)
2,000mg/m2 Capecitabine + 150 Y90
capecitabine C14H15FN3O7
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
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)
2,000 mg/m2 capecitabine = 170 Y90
capecitabine C14H15FN3O7
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
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 Outcomes

Measure
Maximal tolerated dose of yttrium Y 90
time frame: During treatment and any time up to 6 weeks post-treatment
Toxicity
time frame: During treatment and up to 30 days post-treatment
Time to tumor progression
time frame: At time of disease progression

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver
Principal investigator Mary Mulcahy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Northwestern University.