Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment
RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. 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. Giving cetuximab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine work in treating patients with metastatic colorectal cancer.
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymorphism analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: immunohistochemistry staining method
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Duration of overall survival (median and 1-year rate) [ Designated as safety issue: No ]
- Progression-free survival (median) [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Tolerance to therapy [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
- 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 samples.
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.
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|Study Chair:||Stephen I. Shibata, MD||Beckman Research Institute|