Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
Status:
Terminated
Trial end date:
2006-10-01
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. Trastuzumab is synergistic in vitro with multiple chemotherapeutic
agents including the platinum compounds. Studies have shown the efficacy of trastuzumab
combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer.
This trial will investigate the activity of capecitabine and oxaliplatin administered with
trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.