Clinical trial NCT00858429: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Cancer
Metastatic Cancer
Keywords: advanced adult primary liver cancer
liver metastases
adult primary cholangiocellular carcinoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximal tolerated dose of yttrium Y 90
timeFrame: During treatment and any time up to 6 weeks post-treatment
measure: Toxicity profile of yttrium Y 90
timeFrame: During treatment and up to 30 days post-treatment
measure: Time to tumor progression
timeFrame: At time of disease progression
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Mary Mulcahy, MD
role: PRINCIPAL_INVESTIGATOR
References: