Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Cetuximab Plus P-HDFL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years Histologically proven adenocarcinoma At least one measurable lesion (by RECIST) No prior chemotherapy for gastric cancer WHO performance status ≦ 2 Adequate baseline organ functions Fasting serum triglyceride level > 70 mg/dL Written informed consent At least one month from gastrectomy Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR Exclusion Criteria: Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy CNS metastasis Pregnancy, breast-feeding women and women of child-bearing potential Life expectancy less 3 months Serious concomitant illness Concurrent or prior second malignancy Known hypersensitivity reaction to any of the components of study treatments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetuximab Plus P-HDFL<br>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. | Drug: Cetuximab Plus P-HDFL<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed objective response rates |  | Confirmed objective response within 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS), overall survival (OS), treatment-related toxicity |  | 3 years and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combination, Chemotherapy, Gastric cancer