NCT00103324

S0413 Lapatinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer

Phase II Study of GW572016 (NSC-727989) as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Diffuse Adenocarcinoma of the Stomach
• Intestinal Adenocarcinoma of the Stomach
• Mixed Adenocarcinoma of the Stomach
• Recurrent Gastric Cancer
• Stage III Gastric Cancer
• Stage IV Gastric Cancer

Interventions

Type	Name	Description
DRUG	lapatinib ditosylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-05-01
• First posted: 2005-02-08
• Last updated: 2013-01-17

Locations

1 site across 1 country: United States