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

Sponsored by Northwestern University

Phase Quota
Phase 1

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.

Study Start Date: March 2009

Estimated Completion Date: December 2017

Specialties: Gastroenterology: GI Oncology,Hepatology,Pharmacology/kinetics Oncology: Hepatobiliary/Pancreas,Pharmacology/Therapy,Radiation Oncology Pharmacy: Chemotherapy/Oncology Radiology: Radiotherapy (XRT)

Interventions

  • Radiation: yttrium Y 90 glass microspheres
  • Drug: capecitabine

Inclusion 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

Exclusion criteria

Study Locations And Contact Information

  • Northwestern University, Chicago Illinois

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