Clinical Trials Directory

Trials / Completed

CompletedNCT01900002

Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

A Phase II Study of Sorafenib and Yttrium-90 Glass Microspheres for Advanced Hepatocellular Carcinoma, BCLC Stage C

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
40 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well sorafenib tosylate and yttrium Y 90 glass microspheres work in treating patients with liver cancer that cannot be removed by surgery. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Yttrium Y 90 glass microspheres use glass beads to carry radiation directly to tumor cells without harming normal cells. Giving sorafenib tosylate with yttrium Y 90 glass microspheres may be an effective treatment for liver cancer.

Detailed description

PRIMARY OBJECTIVES: I. Median progression-free survival (PFS). SECONDARY OBJECTIVES: I. Overall survival (OS). II. Time to radiographic progression (TTRP). III. To evaluate the safety of the combination of sorafenib (sorafenib tosylate) and Yttrium-90; adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 \[NCI-CTAE v 4.0\]). OTHER OBJECTIVES: I. Predictive biomarkers of response to therapy and survival: will assess pre-treatment plasma level of insulin-like growth factor 1 (IGF-1) as above, and assess its predictive ability of time to progression (TTP) and OS. OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily (BID). After 4 weeks, patients receive yttrium Y 90 glass microspheres intra-arterially (IA). Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Conditions

Interventions

TypeNameDescription
OTHERLaboratory Biomarker AnalysisCorrelative studies
OTHERQuality-of-Life AssessmentAncillary studies
DRUGSorafenibGiven PO
DRUGSorafenib TosylateGiven PO
RADIATIONYttrium Y 90 Glass MicrospheresGiven IA

Timeline

Start date
2013-09-13
Primary completion
2020-12-10
Completion
2020-12-10
First posted
2013-07-16
Last updated
2021-12-30
Results posted
2021-12-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01900002. Inclusion in this directory is not an endorsement.