An Exploratory Study of Chemotherapy for Metastatic Colorectal Cancer Based Upon Thymidine Phosphorylase Expression, KRAS and BRAF Mutation Status, and ERCC1 Expression

NCT01280643 NA TERMINATED Results posted

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, capecitabine, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab and 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. Giving combination chemotherapy together with bevacizumab or cetuximab may kill more tumor cells. PURPOSE:To evaluate the use of standard (KRAS) and experimental (thymidine phosphorylase, ERCC1 and BRAF) tumor testing can aid in selecting chemotherapy regimens

Details

Lead sponsor	Fox Chase Cancer Center
Phase	NA
Status	TERMINATED
Enrolment	3
Start date	2010-03
Completion	2014-05

Conditions

• Metastatic Colorectal Cancer

Interventions

• fluorouracil
• leucovorin calcium
• oxaliplatin
• irinotecan hydrochloride
• bevacizumab
• cetuximab
• capecitabine
• mutation analysis
• gene expression analysis
• laboratory biomarker analysis

Primary outcomes

• Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects — Over 21 months

Countries

United States