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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborators: Chang Gung Memorial Hospital; National Health Research Institutes, Taiwan; Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital
• Treatments: Cetuximab; Cisplatin

Criteria

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