Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer
Status:
Terminated
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a
beneficial contribution to current treatment paradigms since preclinical data suggest that
lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines,
which may contribute to clinical benefit. The study described in this protocol has been
designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in
the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to
search for molecular correlates that may be associated with response to this compound.
The majority of patients with metastatic gastric and gastro-esophageal cancer undergo
first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes
combined to a taxane), but the role of second-line chemotherapy has not yet been defined.
Therefore, progression during or shortly after first-line chemotherapy is a medical condition
no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and
gastroesophageal cancer make these indications prime candidate for treatment with the dual
ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.