Clinical trial · Interventional
A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer
NCT00477711CI-TRIAL-00017949EXTRAcompletedPhase 2ClinicalTrials.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 purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab, cisplatin, capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C225+Chemotherapy
- interventionNames
- Drug: cetuximab, cisplatin, capecitabine
Primary outcomes (1)
- measure
- Tumor response rate
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Time to progression Disease control rate Overall survival K-ras, b-raf, p53 gene mutation and EGFR gene copy number vs. tumor response safety
- timeFrame
- 5 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Having signed informed consent * Age 18 to 75 years old * Histologically confirmed gastric adenocarcinoma * Unresectable recurrent or metastatic disease * Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 12 months * Measurable disease according to the RECIST criteria * Karnofsky performance status ≥60 * Life expectancy of ≥2 month * No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases) * Serum albumin level ≥3.0g/dL * Serum AKP \< 2.5 times ULN * Serum creatinine \<1.5mg/dL * Bilirubin level \< 1.5mg/dL * Serum creatinine \<1.5 times ULN * WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl Exclusion Criteria: * Brain metastasis (known or suspected) * Previous systemic therapy for metastatic gastric cancer * Inability to take oral medication * Previous EGFR pathway-targeting therapy * Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry * Heart failure, coronary artery disease, myocardial infarction within the last 6 months * Known allergy to any study treatment * Pregnancy or lactation period * Any investigational agent within the past 28 days * Other previous malignancy within 5 year, except non-melanoma skin cancer * Previous adjuvant therapy with capecitabine+platinum * Pre-existing neuropathy\>grade 1 * Legal incapacity
References
Publications (1)
- DERIVEDZhang X, Xu J, Liu H, Yang L, Liang J, Xu N, Bai Y, Wang J, Shen L. Predictive biomarkers for the efficacy of cetuximab combined with cisplatin and capecitabine in advanced gastric or esophagogastric junction adenocarcinoma: a prospective multicenter phase 2 trial. Med Oncol. 2014 Oct;31(10):226. doi: 10.1007/s12032-014-0226-y. Epub 2014 Sep 19. PMID 25234930