NCT01145404

Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer

Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: National Center for Tumor Diseases, Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	Lapatinib	Lapatinib (Tyverb) po 1500mg daily d1-21, new cycle will be started on day 22 until progression.
DRUG	Lapatinib plus capecitabine	Lapatinib po 1250mg daily d1-21; new cycle will be started on day 22 until progression

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-02-01
• Completion: 2013-10-01
• First posted: 2010-06-16
• Last updated: 2014-07-02

Locations

16 sites across 1 country: Germany