Status:
COMPLETED
Study of Cetuximab to Treat Gastric Cancer
Lead Sponsor:
Fudan University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy
Detailed Description
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤ 1
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- Adequate hepatic, renal, heart, and hematologic functions (platelets\>80 × 109/L, neutrophil\>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Exclusion
- Pregnant or lactating women
- Concurrent cancer
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Neuropathy, brain, or leptomeningeal involvement
- Uncontrolled significant comorbid conditions and previous radiotherapy
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00699881
Start Date
May 1 2008
End Date
October 1 2009
Last Update
December 23 2009
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China