Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Capecitabine

Lapatinib

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Lapatinib (Tyverb) po 1500mg daily d1-21, new cycle will be started on day 22 until progression.

Lapatinib po 1250mg daily d1-21; new cycle will be started on day 22 until progression

Lapatinib plus capecitabine

Florian Lordick, MD

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.

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

Objective response rate (ORR, complete and partial remission according to RECIST criteria

- all to be confirmed by at least two consecutive tumor response assessments within no shorter than 4 weeks)

recording of AEs/SAEs, vital signs, ECG, LVEF, physical exams, lab values

the definition of biomarkers that are associated with response or resistance to treatment

National Center for Tumor Diseases, Heidelberg

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg

Spots Global Cancer Trial Database for her2 gastro gastric esophageal cancer