drugset / Trial / NCT01432119

Phase 1 Trial With SIR-Spheres and Cetuximab +/- Erlotinib

NCT01432119 ↗

Phase 1 Withdrawn M.D. Anderson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of selective internal radiation (SIR)-Spheres with yttrium-90 attached and cetuximab. Some participants will also take erlotinib with this combination. Yttrium-90 microspheres are designed to treat cancer that has spread to the liver. SIR-Spheres are designed to deliver the radiation directly to the liver. This radiation may cause the tumor cells to die. Cetuximab and erlotinib are drugs that are designed to block the epidermal growth factor receptor (EGFR). EGFR is a protein that helps cancer cells grow. Blocking the EGFR may stop tumors from growing.

Timeline

Start
2012-12
Primary completion
2019-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 200 mg/m2 Intravenous
Subject Erlotinib Small molecule 150 mg Oral