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


Tracking Information

Start Date  ICMJEMarch 2008
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 13, 2008)		Physician visit, side effects and labs will be monitored at every 3 weeks X 24, then every 6 weeks Tumor measurement will be every 6 weeks x 24, then every 12 weeks Gastric tumor biopsy needed pre-study and after one week of lapatinib
Original Primary Outcome Measures  ICMJE 
 (submitted: September 6, 2007)		Physician visit, side effects and labs will be monitored at every 3 weeks X 24, then every 6 weeks Tumor measurement will be every 6 weeks x 24, then every 12 weeks Gastric tumor biopsy needed pre-study and after one week of lapatinib [ Time Frame: 2 Years ]
Change HistoryComplete list of historical versions of study NCT00526669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 6, 2007)		When patient off-study, follow-up contact will occur every 12 weeks for survival Pharmacokinetic blood test to evaluate lapatinib levels in the blood at 6 wks x 4, then every 12 wks Gastric tumor biopsy needed pre-study and after one week of lapatinib [ Time Frame: 2 Years ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib
Official Title  ICMJEAn Exploratory, Phase II Trial to Determine the Association of Lapatinib Induced Fluoropyrimidine Gene Changes With Efficacy Parameters of Lapatinib and Capecitabine in First Line Gastric Cancer
Brief 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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Gastric Cancer
  • Gastro Esophageal(GE)Junction Cancer
Intervention  ICMJEDrug: Lapatinib and Capecitabine
Other Name: Lapatinib and Capecitabine

Recruitment Information

Estimated Enrollment  ICMJE64
Estimated Completion DateFebruary 2011
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJEUnited States,   Canada,   Korea, Republic of,   Mexico,   Russian Federation,   Taiwan

Administrative Information

NCT ID  ICMJENCT00526669
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJELPT109747
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical Trials, MDGlaxoSmithKline
Information Provided ByGlaxoSmithKline