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

National Taiwan University

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Cetuximab Plus P-HDFL

Study type: Interventional

Funder types: Other

Identifiers

NCT00275951

941004

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Cetuximab Plus P-HDFL

Experimental group

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.

Treatment:

Drug: Cetuximab Plus P-HDFL