Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Capecitabine; Lapatinib

Criteria

Inclusion Criteria:

• Has signed inform consent

• Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer, including the gastro-esophageal junction

• Tumor accessible to and patient consent for endoscopic biopsy at study start and after 7 days of single agent Lapatinib

• Measurable disease according to RECIST criteria

• Male or female > or = 18 years of age

• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram

• must have adequate organ function as defined by baseline laboratory values

Exclusion Criteria:

• Gastric carcinoid, sarcomas, or squamous cell cancer

• Pregnant or lactating females

• Intractable nausea, vomiting, or gastro intestinal obstruction requiring decompression and drainage with a gastric tube or nasogastric suction.

• patients who require continuous enteral feeding

• Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative colitis

• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure