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

Completed · Phase 2

Conditions studied: Neoplasms, Gastrointestinal Tract

In brief

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.

Key facts

Study ID

NCT00526669

Run by

GlaxoSmithKline

People needed

68

Starts

2008-03-01

Expected to finish

2015-01-01

Last updated by the study team

2016-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Loma Linda, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Shreveport, Louisiana, United States
• GSK Investigational Site — Ann Arbor, Michigan, United States
• GSK Investigational Site — Southgate, Michigan, United States
• GSK Investigational Site — Jefferson City, Missouri, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Mexico City, Mexico
• GSK Investigational Site — Astrakhan, Russia
• GSK Investigational Site — Chelyabinsk, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Ufa, Russia
• GSK Investigational Site — Hwasun, South Korea
• GSK Investigational Site — Seoul, South Korea
• GSK Investigational Site — Seoul, South Korea
• GSK Investigational Site — Suwon, Gyeonggi-do, South Korea
• GSK Investigational Site — Changhua, Taiwan
• GSK Investigational Site — Taipei, Taiwan
• GSK Investigational Site — Taipei, Taiwan
• GSK Investigational Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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