Status:
COMPLETED
Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
Lead Sponsor:
Northwestern University
Conditions:
Liver Cancer
Metastatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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 o...
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. * Charac...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00858429
Start Date
April 1 2009
End Date
July 8 2014
Last Update
September 9 2019
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611