Clinical trial · Interventional
Study of Cetuximab to Treat Gastric Cancer
Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy
NCT00699881CI-TRIAL-00002916STAGEcompletedPhase 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 evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy
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 | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- administer cetuximab in combination with modified FOLFIRI
- interventionNames
- Drug: cetuximab
Primary outcomes (1)
- measure
- time to progression
- timeFrame
- every 8 weeks
Secondary outcomes (1)
- measure
- toxicity
- timeFrame
- every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ECOG performance scale ≤ 1 * At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan) * Adequate hepatic, renal, heart, and hematologic functions (platelets\>80 × 109/L, neutrophil\>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN) Exclusion Criteria: * Pregnant or lactating women * Concurrent cancer * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Neuropathy, brain, or leptomeningeal involvement * Uncontrolled significant comorbid conditions and previous radiotherapy
References
Publications (1)
- DERIVEDLiu X, Guo W, Zhang W, Yin J, Zhang J, Zhu X, Liu T, Chen Z, Wang B, Chang J, Lv F, Hong X, Wang H, Wang J, Zhao X, Wu X, Li J. A multi-center phase II study and biomarker analysis of combined cetuximab and modified FOLFIRI as second-line treatment in patients with metastatic gastric cancer. BMC Cancer. 2017 Mar 14;17(1):188. doi: 10.1186/s12885-017-3174-z. PMID 28288572