Status:
COMPLETED
Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
National Health Research Institutes, Taiwan
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed 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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00275951
Start Date
December 1 2005
End Date
June 1 2009
Last Update
November 16 2012
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100