Clinical trial · Interventional
Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
Phase II Study of Cetuximab Plus P-HDFL(Cisplatin and Weekly 24-Hour Infusion of High-dose 5-Fluorouracil and Leucovorin)for the First-line Treatment of Advanced Gastric Cancer
NCT00275951CI-TRIAL-00008504FLAGcompletedPhase 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 investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination 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 Plus P-HDFL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab Plus P-HDFL
- description
- Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.
- interventionNames
- Drug: Cetuximab Plus P-HDFL
Primary outcomes (1)
- measure
- Confirmed objective response rates
- timeFrame
- Confirmed objective response within 4 weeks
Secondary outcomes (1)
- measure
- Progression-free survival (PFS), overall survival (OS), treatment-related toxicity
- timeFrame
- 3 years and 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 75 years 2. Histologically proven adenocarcinoma 3. At least one "measurable" lesion (by RECIST) 4. No prior chemotherapy for gastric cancer 5. WHO performance status ≦ 2 6. Adequate baseline organ functions 7. Fasting serum triglyceride level \> 70 mg/dL 8. Written informed consent 9. At least one month from gastrectomy 10. Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR Exclusion Criteria: 1. Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy 2. CNS metastasis 3. Pregnancy, breast-feeding women and women of child-bearing potential 4. Life expectancy less 3 months 5. Serious concomitant illness 6. Concurrent or prior second malignancy 7. Known hypersensitivity reaction to any of the components of study treatments
References
Publications (0)
Data not yet available
No reference posted for this study.