Stage IV Gastric Cancer Clinical Trial
Official title:
Phase II Study of GW572016 (NSC-727989) as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To assess the confirmed response (complete and partial) probability in patients with
advanced/metastatic gastric cancer treated with GW572016.
II. To assess the time to treatment failure and overall survival in this group of patients.
III. To assess the qualitative and quantitative toxicities associated with this regimen.
IV. To assess, in a preliminary manner, the relationship of protein expression and gene
expression of EGFR, HER2 and markers of angiogenesis with clinical outcomes in patients
treated with GW572016.
OUTLINE: This is a multicenter study.
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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