CA225103: A Phase II Study of a Combination of Cetuximab and Capecitabine in Patients With Metastatic Colorectal Cancer After Progression on Previous Fluoropyrimidine Containing Therapy
- Determine the response rate in patients with metastatic colorectal cancer treated with
cetuximab and capecitabine that progressed on prior fluoropyrimidine-containing therapy
comprising irinotecan with or without oxaliplatin.
- To determine the progression-free survival and overall survival of patients treated
with this regimen.
- To determine the tolerance to therapy in these patients.
- To assess biological correlates of response in available tissue biopsies and blood
OUTLINE: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and oral
capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood collection periodically for correlative studies.
Samples are analyzed for expression of genes correlated with fluoropyrimidine responsiveness
via quantitation RT-PCR; degree of expression of EGFR via immunohistochemistry; and
expression pattern analysis via gene expression profiling and polymorphism.
After completion of study treatment, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Stephen I. Shibata, MD
Beckman Research Institute
United States: Federal Government
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|