Phase 2
Completed N=67
Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib
Neoplasms, Gastrointestinal Tract
Source: ClinicalTrials.gov NCT00526669 ↗
Enrolled (actual)
67
Serious AEs
32.8%
Results posted
Oct 2012
Primary outcomePrimary: Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 — 0.38; 0.12; 0.15; 0.01 ratio — p=0.10
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 |
0.38; 0.12; 0.15; 0.01; 0.87 | 0.10 |
| PRIMARY Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response]) |
17.9 | — |
| PRIMARY Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS) |
29 | — |
| SECONDARY PFS |
14.3 | — |
| SECONDARY Overall Survival (OS) |
27.6 | — |
| SECONDARY Time to Progression (All Deaths Are Treated as Competing Risk) |
18.9 | — |
| SECONDARY Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk) |
14.3 | — |
| SECONDARY Time to Response |
NA | — |
| SECONDARY Duration of Response |
18.4 | — |
| SECONDARY Number of Participants in the Indicated Categories for Best Overall Response (BOR) |
0; 12; 31; 16; 8 | — |
| SECONDARY 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 |
10; 9; 10; 4; 2; 4 | — |
| SECONDARY 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 |
6; 5; 8; 5; 2; 5 | — |
| SECONDARY 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 |
1; 3; 3; 6; 3; 2 | — |
| SECONDARY 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 |
1; 0; 2; 3; 2; 2 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points |
0; 2; 1; 2; 8; 3 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points |
7; 4; 5; 3; 3; 2 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points |
2; 1; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points |
13; 10; 10; 7; 6; 4 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points |
9; 3; 5; 3; 4; 4 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points |
1; 6; 3; 4; 1; 0 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points |
9; 7; 5; 7; 4; 1 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points |
10; 16; 12; 10; 7; 6 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points |
0; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points |
1; 2; 0; 2; 3; 2 | — |
| SECONDARY 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 |
5; 9; 6; 5; 3; 7 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00526669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.