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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Neoplasms, Gastrointestinal Tract

Treatments: Drug: Lapatinib and Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00526669

LPT109747

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)