drugset / Trial / NCT01044420
mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial
Non-randomizedSingle-groupOpen-labelTreatment
Summary
There are few studies about 2nd line treatment in advanced esophageal carcinoma(AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.
Timeline
- Start
- 2009-05
- Primary completion
- 2011-06
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2.4 g | Intravenous |
| Subject | fluorouracil | Small molecule | 3 g | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |