Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
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.
Radiation: yttrium Y 90 glass microspheres
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver|
- Maximal tolerated dose of yttrium Y 90 [ Time Frame: During treatment and any time up to 6 weeks post-treatment ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: During treatment and up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
- Time to tumor progression [ Time Frame: At time of disease progression ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR)
- 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.
|Contact: Mary Mulcahy, MDfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Study Coordinator 312-695-1301 email@example.com|
|Principal Investigator:||Mary Mulcahy, MD||Robert H. Lurie Cancer Center|