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

Gastric Cancer Clinical Trial

— FLAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275951
• Other study ID #: 941004
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2006
• Last updated: November 15, 2012
• Start date: December 2005
• Est. completion date: June 2009

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Cetuximab 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.

Locations

Country	Name	City	State
Taiwan	Department of Oncology, National Taiwan University Hospital	Taipei

Sponsors (5)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Chang Gung Memorial Hospital, National Health Research Institutes, Taiwan, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed objective response rates		Confirmed objective response within 4 weeks	No
Secondary	Progression-free survival (PFS), overall survival (OS), treatment-related toxicity		3 years and 5 years	Yes