Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms, Gastrointestinal Tract
Intervention: Lapatinib and Capecitabine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: An 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Start of Run-in Period in Biomarker Expression Levels at Day 0Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response]) Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)
Secondary outcome: PFSOverall Survival (OS) Time to Progression (All Deaths Are Treated as Competing Risk) Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk) Time to Response Duration of Response Number of Participants in the Indicated Categories for Best Overall Response (BOR) Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
GSK Investigational Site, Hwasun 519-809, Korea, Republic of
GSK Investigational Site, Seoul 110-744, Korea, Republic of
GSK Investigational Site, Seoul 120-752, Korea, Republic of
GSK Investigational Site, Suwon, Gyeonggi-do 442-723, Korea, Republic of
GSK Investigational Site, Mexico City CP 14080, Mexico
GSK Investigational Site, Astrakhan 414044, Russian Federation
GSK Investigational Site, Chelyabinsk 454087, Russian Federation
GSK Investigational Site, St. Petersburg 197022, Russian Federation
GSK Investigational Site, Ufa, 450054, Russian Federation
GSK Investigational Site, Changhua 500, Taiwan
GSK Investigational Site, Taipei 100, Taiwan
GSK Investigational Site, Taipei 104, Taiwan
GSK Investigational Site, Taipei 112, Taiwan
GSK Investigational Site, Loma Linda, California 92354, United States
GSK Investigational Site, Los Angeles, California 90033, United States
GSK Investigational Site, Washington, District of Columbia 20007, United States
GSK Investigational Site, Shreveport, Louisiana 71103, United States
GSK Investigational Site, Ann Arbor, Michigan 48109, United States
GSK Investigational Site, Southgate, Michigan 48195, United States
GSK Investigational Site, Jefferson City, Missouri 65109, United States
GSK Investigational Site, Montreal, Quebec H3T 1E2, Canada
GSK Investigational Site, Dallas, Texas 75137, United States
Additional Information
Starting date: March 2008
Last updated: July 27, 2015
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