A Phase II Study of Yttrium-90 Radioactive Resin Microspheres in the Treatment of Colorectal Adenocarcinoma Metastatic to the Liver After Failure of First-Line Combination Chemotherapy
This is a phase II, single-arm study of Yttrium-90 (Y-90) radioactive resin microspheres in
the treatment of colorectal adenocarcinoma metastatic to the liver in patients who have had
progressive disease through first line combination chemotherapy or have otherwise failed
first line chemotherapy due to toxicity. Expected enrollment at UCSD is approximately 34
subjects.
The dose of Yttrium-90 radioactive resin microspheres is calculated based on body surface
area (to estimate normal liver volume), percentage of total liver represented by the
targeted lobe, and percentage of the lobe that is occupied by tumor, corrected for
percentage lung shunt. The prescribed dose, calculated by the nuclear medicine physician,
will be delivered by the interventional radiologist using the standard delivery system with
frequent fluoroscopic monitoring to assure ante grade blood flow immediately after
treatment. Additional current standard practice includes obtaining a nuclear medicine scan
of the patient immediately after each therapeutic Yttrium-90 microspheres administration to
prove delivery of the agent to the targeted portion of the liver and absence of either
extra-hepatic Yttrium-90 delivery or free Yttrium-90.
Blood samples will be obtained one week after the first treatment with microspheres. If the
patient has bi-lobar disease and the results of lab tests meet protocol specified criteria,
the dose will be repeated in the initially-untreated lobe. If the lab tests do not meet
protocol specified criteria (i.e. study inclusion/exclusion criteria), the treatment will be
deferred for fourteen days and labs repeated. If they are then within parameters, the
patient will receive the second dose. If they are not within parameters, the patient will
proceed to chemotherapy.
Patients will remain off chemotherapy after their final microspheres treatment for a minimum
of three weeks. Second line treatment options include FDA approved anti-neoplastic agents
used in colorectal cancer metastatic to the liver with the exception of bevacizumab and
capecitabine, which has been less rigorously studied with relation to Yttrium-90 radioactive
microspheres and therefore will not be used. When patients are found to have progressive
disease while receiving second line chemotherapy, they will then undergo a comprehensive
clinical, laboratory, and imaging assessment and enter the follow-up phase in which they are
assessed every five to seven months until death or withdrawal of consent.
A contrast enhanced ultrasound (CEUS) will be performed pre microsphere treatment (within 14
days), post microsphere treatment (2 weeks, 4 weeks, 8 weeks and 12 weeks post the
microsphere treatment). If patients require two treatments with microspheres, they will be
evaluated 2, 4, 8 and 12 weeks post the second treatment.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria using Computerized Tomography (CT) assessment of tumor(s) at 6 months since the diagnosis date of disease progression on first-line therapy.
4 years
No
Tony Reid, MD, PhD
Principal Investigator
University of California, San Diego
United States: Food and Drug Administration
071960
NCT01098422
January 2010
January 2014
Name | Location |
---|---|
UCSD Medical Center | La Jolla, California 92093 |
Thornton Hospital | La Jolla, California 92037 |
The Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093 |