This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.
Although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more than one drug may be more effective. In this phase Ⅱ trial, the investigator would like to observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Disease control rate
Time frame: Up to 24 weeks
Overall survival
Time frame: From the date of first drug administration until the date of death, assessed up to 60months
Adverse events
Safety profile will be assessed using the NCI CTCAE version 3.0
Time frame: Each follow up visit, assessed up to 24 weeks
Progression free survival
Time frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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