Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin
with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of
patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor
selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher
levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal
tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to
surrounding normal tissue. This trial will investigate the activity of this novel
capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition,
an exploratory analysis will correlate response with thymidine synthase and thymidine
phosphorylase expression in primary tumor samples.