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

Sponsor
National Center for Tumor Diseases, Heidelberg
Study ID
NCT01145404
Phase
PHASE2
Status
Terminated

Conditions

  • GastroEsophageal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2010
Status verified
Jul 2014
Primary completion
Feb 28, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Lapatinib
    Lapatinib (Tyverb) po 1500mg daily d1-21, new cycle will be started on day 22 until progression.
  • Experimental: Arm B
    Lapatinib po 1250mg daily d1-21; new cycle will be started on day 22 until progression

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: about 10 month (until progression) ]

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