Clinical trial · Interventional
Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib
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
NCT00526669CI-TRIAL-00020711completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Gastrointestinal Tract | Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib and Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Change From Start of Run-in Period in Biomarker Expression Levels at Day 0
- timeFrame
- evaluated at baseline and after 7 days of study treatment
- description
- Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.
- measure
- Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])
- timeFrame
- From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)
- description
- Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as \>= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLaBonte MJ, Yang D, Zhang W, Wilson PM, Nagarwala YM, Koch KM, Briner C, Kaneko T, Rha SY, Gladkov O, Urba SG, Sakaeva D, Pishvaian MJ, Hsieh RK, Lee WP, Lenz HJ. A Phase II Biomarker-Embedded Study of Lapatinib plus Capecitabine as First-line Therapy in Patients with Advanced or Metastatic Gastric Cancer. Mol Cancer Ther. 2016 Sep;15(9):2251-8. doi: 10.1158/1535-7163.MCT-15-0908. Epub 2016 Jun 20. PMID 27325685