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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00275951

Acronym

FLAG

Enrollment

Registered

2006-01-12

Start date

2005-12-31

Completion date

2009-06-30

Last updated

2012-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Combination, Chemotherapy, Gastric cancer

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.

Interventions

DRUGCetuximab Plus P-HDFL

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Confirmed objective response rates	Confirmed objective response within 4 weeks

Secondary

Measure	Time frame
Progression-free survival (PFS), overall survival (OS), treatment-related toxicity	3 years and 5 years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026