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

National Taiwan University Hospital39 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer

Interventions

Cetuximab Plus P-HDFLDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Oncology, National Taiwan University Hospital

Taipei, Taiwan

Outcomes

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

Data from ClinicalTrials.gov

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