---
title: Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
nct_id: NCT00275951
overall_status: COMPLETED
phase: PHASE2
sponsor: National Taiwan University Hospital
study_type: INTERVENTIONAL
primary_condition: Gastric Cancer
countries: Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00275951.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00275951"
ct_last_update_post_date: 2012-11-16
last_seen_at: "2026-05-12T07:09:07.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer

**Official Title:** 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

**NCT ID:** [NCT00275951](https://clinicaltrials.gov/study/NCT00275951)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 39
- **Lead Sponsor:** National Taiwan University Hospital
- **Collaborators:** Taipei Veterans General Hospital, Taiwan, National Health Research Institutes, Taiwan, Chang Gung Memorial Hospital, Tri-Service General Hospital
- **Conditions:** Gastric Cancer
- **Start Date:** 2005-12
- **Completion Date:** 2009-06
- **CT.gov Last Update:** 2012-11-16

## Brief Summary

The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.

## Detailed Description

The clinical efficacy (confirmed objective response rates, progression-free survival, overall survival), and treatment-related toxicities of this novel regimen will be examined as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Cetuximab Plus P-HDFL** (EXPERIMENTAL) — 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.

## Interventions

- **Cetuximab Plus P-HDFL** (DRUG) — 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.

## Primary Outcomes

- **Confirmed objective response rates** _(time frame: Confirmed objective response within 4 weeks)_

## Secondary Outcomes

- **Progression-free survival (PFS), overall survival (OS), treatment-related toxicity** _(time frame: 3 years and 5 years)_

## Locations (1)

- Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of oncology, national taiwan university hospital|taipei||taiwan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00275951.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00275951*  
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