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

NCT01145404 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-07-02

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Center for Tumor Diseases, Heidelberg

    lead OTHER

Principal Investigators

  • Florian Lordick, MD · Academic Teaching Hospital Braunschweig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-02-28
Completion
2013-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01145404 on ClinicalTrials.gov